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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM
10-Q
 
 
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2024
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
Montrouge 92120 France
  
N/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)
  
Name of each exchange
on which registered
American Depositary Shares, each representing
one-half
of one ordinary share, nominal value
€0.10 per share
  
DBVT
  
The Nasdaq Stock Market LLC
Ordinary shares, nominal value €0.10 per share*
  
n/a
  
The Nasdaq Stock Market LLC
 
*
Not for trading, but only in connection with the registration of the American Depositary Shares.
Securities registered pursuant to section 12(g) of the Act: None.
 
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation
S-T
(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging 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 May 7, 2024, the registrant had 96,434,369
      
ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
 
 
 

Table of contents

 

Part I

   Financial information      3  

Item 1

   Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31, 2024 and December 31, 2023      3  
  Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three Months Ended March 31, 2024 and 2023      4  
  Condensed Consolidated Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2024 and 2023      5  
  Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Three Months Ended March 31, 2024 and 2023      6  
  Notes to the Condensed Consolidated Financial Statements (Unaudited)      7  

Item 2

   Management’s Discussion and Analysis of Financial Condition and Results of Operations      18  

Item 3

   Quantitative and Qualitative Disclosures About Market Risk      23  

Item 4

   Controls and Procedures      23  

Part II

   Other Information      24  

Item 1

   Legal Proceedings      24  

Item 1A

   Risk Factors      24  

Item 2

   Unregistered Sales of Equity Securities and Use of Proceeds      24  

Item 3

   Defaults Upon Senior Securities      24  

Item 4

   Mine Safety Disclosures      24  

Item 5

   Other Information      24  

Item 6

   Exhibits      25  

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

 

558800010174
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 (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, (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:
 
  •  
our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated
re-submission
of a Biologics License Application, or a BLA, for Viaskin
TM
Peanut to the U.S. Food and Drug Administration, or the FDA;
 
  •  
the design, timing and anticipated results of 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 funding;
 
  •  
our financial performance;
 
  •  
developments relating to our competitors and our industry, including competing therapies; 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, 2023, filed with the Securities and Exchange Commission, or the SEC on March 7, 2024. 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
Part I - Financial Information
Item 1. Financial Statements
DBV Technologies S.A.
Condensed Consolidated Statements of Financial Position (unaudited)
(amounts in thousands, except share and per share data)
 
           
March 31,
    
December 31,
  
    
Note
     
2024
    
2023
  
Assets
        
Current assets:
        
Cash and cash equivalents
   
 
3
 
    $ 101,525     $ 141,367  
Other current assets
   
 
4
 
      18,037       17,548  
     
 
 
    
 
 
  
Total current assets
      
 
119,562
 
  
 
158,915
 
Property, plant, and equipment, net
         12,913       12,623  
Right-of-use
assets related to operating leases
   
 
5
 
      6,551       5,247  
Intangible assets
         52       58  
Other
non-current
assets
         6,818       6,144  
     
 
 
    
 
 
  
Total
non-current
assets
      
 
26,334
 
  
 
24,071
 
     
 
 
    
 
 
  
Total Assets
      
$
145,895
 
  
$
182,986
 
     
 
 
    
 
 
  
Liabilities and shareholders’ equity
        
Current liabilities:
        
Trade payables
   
 
6
 
    $ 18,076     $ 23,302  
Short-term operating leases
   
 
5
 
      232       1,144  
Current contingencies
   
 
9
 
      3,153       3,959  
Other current liabilities
   
 
6
 
      5,023       8,934  
     
 
 
    
 
 
  
Total current liabilities
      
 
26,483
 
  
 
37,339
 
     
 
 
    
 
 
  
Long-term operating leases
   
 
5
 
      6,793       4,526  
Non-current
contingencies
   
 
9
 
      965       935  
Other
non-current
liabilities
   
 
6
 
      —        —   
     
 
 
    
 
 
  
Total
non-current
liabilities
      
 
7,758
 
  
 
5,461
 
     
 
 
    
 
 
  
Total Liabilities
      
$
34,241
 
  
$
42,799
 
     
 
 
    
 
 
  
Shareholders’ equity:
        
Ordinary shares, €0.10 par value; 96,434,369 and 96,431,770 shares authorized, and issued as of March 31, 2024 and December 31, 2023, respectively
       $ 10,972     $ 10,972  
Additional
paid-in
capital
         379,426       377,468  
Treasury stock, 262,644 and 222,988 ordinary shares as of March 31, 2024 and December 31, 2023, respectively, at cost
         (1,325 )      (1,263 ) 
Accumulated deficit
         (266,207  )      (238,862  ) 
Accumulated other comprehensive income
         683       742  
Accumulated currency translation effect
         (11,897 )      (8,871 ) 
     
 
 
    
 
 
  
Total Shareholders’ equity
   
 
7
 
   
$
111,654
 
  
$
140,187
 
     
 
 
    
 
 
  
Total Liabilities and Shareholders’ equity
      
$
145,895
 
  
$
182,986
 
     
 
 
    
 
 
  
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
3
DBV Technologies S.A.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(amounts in thousands, except share and per share data)
 
           
Three Months Ended

March 31,
  
    
Note
     
2024
    
2023
  
Operating income
   
 
10
 
   
$
1,407
 
  
$
2,194
 
Operating expenses
        
Research and development expenses
   
 
11
 
      (21,403 )      (16,037 ) 
Sales and marketing expenses
   
 
11
 
      (758 )      (434 ) 
General and administrative expenses
   
 
11
 
      (7,804 )      (6,889 ) 
     
 
 
    
 
 
  
Total Operating expenses
      
 
(29,964
) 
  
 
(23,359
) 
     
 
 
    
 
 
  
Loss from operations
      
 
(28,558
) 
  
 
(21,165
) 
     
 
 
    
 
 
  
Financial income(expenses)
   
 
13
 
      1,261       605  
     
 
 
    
 
 
  
Loss before taxes
      
 
(27,297
) 
  
 
(20,561
) 
     
 
 
    
 
 
  
Income tax (expense)
         (48 )      —   
     
 
 
    
 
 
  
Net loss
      
$
(27,345
) 
  
$
(20,561
) 
     
 
 
    
 
 
  
Foreign currency translation differences, net of taxes
         (3,026 )      3,666  
Actuarial gains (losses) on employee benefits, net of taxes
         (59 )      (82 ) 
     
 
 
    
 
 
  
Total comprehensive loss
      
$
(30,429
) 
  
$
(16,977
) 
     
 
 
    
 
 
  
Basic/diluted Net loss per share attributable to shareholders
   
 
15
 
   
$
(0.28
) 
  
$
(0.22
) 
Weighted average shares outstanding used in computing per share amounts:
         96,176,057       93,970,598  
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
4
DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)
 
           
Three Months Ended March 31,
  
    
Notes
     
2024
    
2023
  
Net loss for the period
      
$
(27,345
) 
  
$
(20,561
) 
Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities:
        
Depreciation, amortization and accrued contingencies
         53       (228 ) 
Retirement pension obligations
         (8 )      (35 ) 
Expenses related to share-based payments
   
 
8
 
      1,958       1,632  
Other elements
         —          —     
Changes in operating assets and liabilities:
        
Decrease (increase) in other current assets
         (835 )      (3,098 ) 
(Decrease) increase in trade payables
         (4,805 )      4,478  
(Decrease) increase in other current and
non-current
liabilities
         (3,765 )      (2,989 ) 
Change in operating lease liabilities and right of use assets
         56       (42 ) 
Net cash flow provided by (used in) operating activities
      
 
(34,692
) 
  
 
(20,841
) 
     
 
 
    
 
 
  
Cash flows provided by (used in) investing activities:
        
Acquisitions of property, plant, and equipment
         (1,335 )      (111 ) 
Proceeds from property, plant, and equipment dispositions
         —          —     
Acquisitions of
non-current
financial assets
         (858 )      —   
Proceeds from
non-current
financial assets dispositions
         62       153  
     
 
 
    
 
 
  
Net cash flows provided by (used in) investing activities
      
 
(2,132
) 
  
 
42
 
     
 
 
    
 
 
  
Cash flows provided by (used in) financing activities:
        
(Decrease) increase in conditional advances
         —          —     
Treasury shares
         (62 )      (14 ) 
     
 
 
    
 
 
  
Net cash flows provided by (used in) financing activities
      
 
(62
) 
  
 
(14
) 
     
 
 
    
 
 
  
Effect of exchange rate changes on cash and cash equivalents
         (2,957 )      3,909  
     
 
 
    
 
 
  
Net increase (decrease) in cash and cash equivalents
      
 
(39,842
) 
  
 
(16,905
) 
     
 
 
    
 
 
  
Net Cash and cash equivalents at the beginning of the period
         141,367       209,194  
     
 
 
    
 
 
  
Net cash and cash equivalents at the end of the period
   
 
3
 
   
$
101,525
 
  
$
192,289
 
     
 
 
    
 
 
  
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
5
DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)
(amounts in th
ousands, 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, 2023
   
 
94,137,145
 
   
$
 10,720
 
   
$
458,221
 
  
$
(1,109
) 
  
$
(259,578
) 
  
$
781
 
  
$
(14,581
) 
  
$
194,453
 
Net (loss)
      —         —         —        —        (20,561 )      —        —        (20,561 ) 
Other comprehensive income (loss)
      —         —         —        —        —        (82 )      3,666       3,584  
Issuance of ordinary shares
     
10 174
        1        (1 )      —        —        —        —        —   
Treasury shares
      —         —         —        (14 )      —        —        —        (14 ) 
Share-based payments
      —         —         1,632       —        —        —        —        1,632  
  
 
 
     
 
 
     
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Balance at March 31, 2023
   
 
94,147,319
 
   
$
10,721
 
   
$
459,852
 
  
$
(1,123
) 
  
$
(280,138
) 
  
$
698
 
  
$
(10,915
) 
  
$
179,094
 
 
    
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, 2024
   
 
96,431,770
 
   
$
10,972
 
   
$
377,468
 
  
$
(1,263
) 
  
$
(238,862
) 
  
$
742
 
  
$
(8,871
) 
  
$
140,187
 
Net (loss)
      —         —         —        —        (27,345 )      —        —        (27,345 ) 
Other comprehensive income (loss)
      —         —         —        —        —        (59 )      (3,026 )      (3,084 ) 
Issuance of ordinary shares
      2,599        3        (3 )      —        —        —        —        —   
Treasury shares
      —         —         —        (62 )      —        —        —        (62 ) 
Share-based payments
      —         —         1,958       —        —        —        —        1,958  
  
 
 
     
 
 
     
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Balance at March 31, 2024
   
 
96,434,369
 
   
$
10,972
 
   
$
379,426
 
  
$
(1,325
) 
  
$
(266,207
) 
  
$
683
 
  
$
(11,897
) 
  
$
111,654
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
6
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”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.
Basis of Presentation
The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.
The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form
10-K
filed with the SEC on March 7, 2024 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2023 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, 2023.
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, 2024, 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 wind-down activities resulting from the termination of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets—operating lease, (4) impairment of
right-of-use
assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, (7) estimate of contingencies
,
and (8) estimate of employee benefits obligations.
Going Concern
These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists.
Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin Peanut, in August 2020, the Company scaled down its other clinical programs and
pre-clinical
spend to focus on Viaskin Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin Peanut in the United States and European Union.
 
7
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 CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the
6-month
safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population.
Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/ Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol.
In December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch was completed at the end of February 2022 and has been prepared for FDA submission.
In May 2022, the Company established an
At-The-Market
(“ATM”) program allowing 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”). 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 Platform and for working capital and other general corporate purposes.
In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect. The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut- allergic children ages 4 to 7 years.
During the same month, the Company announced private placement financing (“PIPE”) amounting to $194 million.
In September 2022, after announcing the initiation of the VITESSE clinical trial, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study. Within the FDA’s communication, the modifications 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.
On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that the VITESSE phase 3 clinical study may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024.
The company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.
Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024 will be sufficient to fund our operations until December 31, 2024.
The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings prior to December 31, 2024. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of
non-dilutive
financings.
The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. The
COVID-19
pandemic and conflict in Ukraine caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
 
8
If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.
These Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern.
Accounting Pronouncements recently adopted
There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements.
There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows.
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.
Note 2: Significant Events and Transactions
Clinical programs
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. 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,
 the
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.
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. The Company completed CHAMP in the second quarter of 2021. 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 the 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 on 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 sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. The Company estimated that the FDA’s newly proposed sequential 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 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. 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.
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
4-7
years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.
 
9
On September 21, 2022, the Company announced it received feedback from the U.S. 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 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 the Company satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE phase 3 clinical study may proceed with the revised trial protocol.
On March 2, 2023, the Company 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 scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA.
On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by the third quarter of 2024.
On April 19, 2023, the Company outlined the regulatory pathway 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 required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.
On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 –
3-years
and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 –
7-years
and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. FDA agreed with a
6-month
study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. 
The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program.
Viaskin Peanut for children ages
4-11—
European Union Regulatory History and Current Status
On August 2, 2021, the Company announced it received from the European Medicines Agency (EMA) 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.
On December 20, 2021, the Company announced it withdrew the Marketing Authorization Application (MAA) for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by 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 clinical 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 clinical 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
In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study, subjects 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 µg dose in this age group, which is the dose being studied in Part B of the EPITOPE phase 3 clinical study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021.
 
10
In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms respectively. Enrollment was balance for age and baseline disease characteristics between the active and placebo treatment arms.
The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages
1
to
3
years, given the high unmet need and absence of approved treatments for this vulnerable population.
On April 19, 2023, the Company outlined the regulatory pathway 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
1-3
years old with a confirmed peanut allergy.
In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.
The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program.
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
4-7
years with peanut allergy.
The Company
defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.
On September 21, 2022, the Company 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,
the Company
engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition,
the Company
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 the last patient is anticipated by
the third quarter of
2024.
In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. In summary, there was an agreement with the Agency that COMFORT Children will be a Double-Blind, Placebo-Controlled study involving approximately 270 children, randomized at a 3:1 ratio (active to placebo). Participation will not necessitate a food challenge, and patch adhesion data will be generated using the same approach as previously agreed upon with the FDA for the VITESSE phase 3 study.
Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children. This feedback included language simplification for how Viaskin should be used. Furthermore, the key inclusion criteria for the COMFORT Children study will be based on a physician-diagnosed peanut allergy, peanut-specific IgE and a Skin Prick Test (with no requirement for a DBPCFC). The revised protocol design of the safety study was submitted to the FDA in Q4 2023. COMFORT Children is anticipated to be initiated towards the end of VITESSE enrollment. The Company intends that enrollment of the COMFORT Children safety study will be strategically timed to avoid competition with the VITESSE study for the same subjects.
Legal Proceedings
From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings.
Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of March 31, 2024 and December 31, 2023:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Cash
      15,725        10,530  
Cash equivalents
      85,800        130,836  
  
 
 
     
 
 
  
Total cash and cash equivalents as reported in the statements of financial position
   
 
101,525
 
   
 
141,367
 
  
 
 
     
 
 
  
 
11
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Bank overdrafts
      —         —   
  
 
 
     
 
 
  
Total cash and cash equivalents as reported in the
statements
of cash flows
   
 
101,525
 
   
 
141,367
 
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:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Research tax credit
      10,066        8,857  
Other tax claims
      5,725        5,236  
Prepaid expenses
      1,727        2,103  
Other receivables
      518        1,353  
  
 
 
     
 
 
  
Total
   
 
18,037
 
   
 
17,548
 
  
 
 
     
 
 
  
Research tax credit
The variance in Research Tax Credit is presented as follows:
 
    
Amount in

thousands of US

Dollars
  
Opening research tax credit receivable as of January 1, 2024
   
 
8,857
 
+ Operating revenue
      1,407  
- Payment received
      —   
- Adjustment and currency translation effect
      (198 ) 
  
 
 
  
Closing research tax credit receivable as of March 31, 2024
   
 
10,066
 
  
 
 
  
Of which -
Non-current
portion
      —   
Of which - Current portion
   
 
10,066
 
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.
 
12
Note 5
:
Lease contracts
Future minimum lease payments under the Company’s operating
leas
es’ right of use as of March 31, 2024 and December 31, 2023, are as follows:
 
    
March 31, 2024
    
December 31, 2023
  
    
Real estate
    
Other

assets
    
Total
    
Real estate
    
Other

assets
    
Total
  
Current portion
      344       61       405       1,205       71       1,275  
Year 2
      1,014       —        1,014       65       11       75  
Year 3
      1,259       —        1,259       421       —        421  
Thereafter
      6,256       —        6,256       5,515       —        5,515  
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Total minimum lease payments
   
 
8,873
 
  
 
61
 
  
 
8,934
 
  
 
7,205
 
  
 
81
 
  
 
7,295
 
Less: Effects of discounting
     (1,902 )      (7 )      (1,909 )      (1,617 )      (9 )      (1,626 ) 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Present value of operating lease
   
 
6,971
 
  
 
54
 
  
 
7,025
 
    
5
,588
    
 
73
 
  
 
5,670
 
Less: current portion
      (178 )      (54 )      (232 )      (1,072  
) 		     (72  
) 		     (1,144  
) 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Long-term operating lease
   
 
6,793
 
     —     
 
6,793
 
  
 
4,516
 
  
 
1
 
  
 
4,526
 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Weighted average remaining lease term (years)
      7.52       0.01       7.95       —     
Weighted average discount rate
      5.00 %      0.03  
% 		       4.53 %      2.50  
% 		  
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:
 
    
March 31,
  
  
2024
     
2023
  
Operating lease expense / (income)
      586        446  
Net termination impact
      (12 )       (81 ) 
Supplemental cash flow information related to operating leases is as follows for the period March 31, 2024 and 2023:
 
    
March 31
  
  
2024
     
2023
  
Cash paid for amounts included in the measurement of lease liabilities
      
Operating cash flows for operating leases
      501        496  
Note 6: Trade Payables and Other Liabilities
6.1 Trade Payables
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.
6.2 Other Current Liabilities
The following tables summarize the other current liabilities as of March 31, 2024 and December 31, 2023:
 
    
March 31
     
December 31,
  
    
2024
     
2023
  
    
Other
 current
liabilities
     
Other
 non-
current
liabilities
     
Total
     
Other
 current
liabilities
     
Other
 non-
current
liabilities
     
Total
  
Employee related liabilities
      4,629        —         4,629        7,828        —         7,828  
Tax liabilities
      180        —         180        223        —         223  
Other debts
      214        —         214        883        —         883  
  
 
 
     
 
 
     
 
 
     
 
 
     
 
 
     
 
 
  
Total
   
 
5,023
 
      —      
 
5,023
 
   
 
8,934
 
      —      
 
8,934
 
  
 
 
     
 
 
     
 
 
     
 
 
     
 
 
     
 
 
  
 
13
The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations as of March 31, 2024. The Employee related liabilities included short-term debt to employees including social welfare, tax agency obligations and bonus provision (paid during first quarter 2024)
as
of December 31, 2023.
Note 7: Shareholders’ equity
The share capital as of March 31, 2024 is set at the sum of €9,643,437 ($10,972 thousands converted at historical rates). It is divided into 96,434,369 fully authorized, subscribed and
paid-up
ordinary
shares with a par value of €0.10.
Note 8: Share-Based Payments
The Board of Directors has been authorized by the Shareholders General Meeting to grant restricted stock units (“RSU”), stock options (“SO”) and
non-employee
warrants (
Bons de Souscription d’Actions
or “BSA”).
During the three months ended March 31, 2024, the Company granted 262,000 stock options and 59,000 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.
 
14
Change in Number of BSA/SO/RSU:
 
    
Number of outstanding
  
    
BSA
     
SO
     
RSUs
  
Balance as of December 31, 2023
   
 
244,693
 
   
 
7,129,541
 
   
 
2,021,370
 
Granted during the period
      —         262,000        59,000  
Forfeited during the period
      —         3,525        13,738  
Exercised/released duri
n
g the period
      —         —         2,598  
Expired during the period
      —         —         —   
  
 
 
     
 
 
     
 
 
  
Balance as of March 31, 2024
   
 
244,693
 
   
 
7,388,016
 
   
 
2,064,035
 
  
 
 
     
 
 
     
 
 
  
Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research & development
      SO        (513 )       (429 ) 
  
 
RSU
 
   
 
(256
) 
   
 
(258
) 
Sales & marketing
      SO        (23 )       (27 ) 
  
 
RSU
 
   
 
(9
) 
   
 
(8
) 
General & administrative
      SO        (1,030 )       (797 ) 
  
 
RSU
 
   
 
(126
) 
   
 
(113
) 
     
 
 
     
 
 
  
Total share-based compensation (expense)
      
 
(1,958
) 
   
 
(1,632
) 
     
 
 
     
 
 
  
The $0.3 million increase in share-based compensation expenses is notably due to the increase of number of ordinary share equivalents granted in 2023 impacting the three months ended March 31, 2024, in comparison to the number granted in 2022 impacting the three months ended March 31, 2023.
Note 9: Contingencies
The following tables summarize the contingencies as of March 31, 2024 and December 31, 2023:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Current contingencies
      3,153        3,959  
Non-current
contingencies
      965        935  
  
 
 
     
 
 
  
Total contingencies
   
 
4,118
 
   
 
4,894
 
  
 
 
     
 
 
  
The changes in contingencies are as follows:
 
    
Pension

retirement

obligations
     
Other

contingencies
     
Total
  
At January 1, 2024
   
 
935
 
   
 
3,959
 
   
 
4,894
 
Increases in liabilities
      —         —         —   
Used liabilities
      —         (723 )       (723 ) 
Reversals of unused liabilities
      (8 )       —         (8 ) 
Net interest related to employee benefits, and unwinding of discount
      —         —         —   
Actuarial gains and losses on defined-benefit plans
      59        —         59  
Currency translation effect
      (20 )       (82 )       (103 ) 
  
 
 
     
 
 
     
 
 
  
At March 31, 2024
   
 
965
 
   
 
3,153
 
   
 
4,118
 
  
 
 
     
 
 
     
 
 
  
 
15
    
Pension

retirement

obligations
     
Other

contingencies
     
Total
  
Of which Current
   
 
— 
 
   
 
3,153
 
   
 
3,153
 
Of which
Non-current
   
 
965
 
   
 
— 
 
   
 
965
 
In May 2016, the Company entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”) under which the Company was responsible for leading the development activities of MAG1C up through a pivotal phase 3 clinical program.
On October 30, 2023, the Company signed and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement.
As of March 31, 2024, the accrual for ongoing Clinical study completion totals $1.3 million (vs. $2.3 million as of December 31, 2023) representing our best estimate of the remaining expenses related to the ongoing clinical study.
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 14 to the consolidated financial statements included in the Annual Report.
Note 10: Operating income
The following table summarizes the operating income during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research tax credit
      1,407        1,765  
Other operating income
      —         429  
  
 
 
     
 
 
  
Total
   
 
1,407
 
   
 
2,194
 
  
 
 
     
 
 
  
As of March 31, 2023, other income were recorded according the Collaboration Agreement between the Company and NESTEC.
On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement, explaining the lack of other income as of March 31, 2024.
Note 11: Operating expenses
The Company had an average of 105 employees during the three months ended March 31, 2024, in comparison with an average of 87 employees during the three months ended March 31, 2023. This increase is mainly due to hiring to support clinical development activities related to ongoing and anticipated clinical trials and to support quality activities.
The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research and Development expenses
      5,048        4,006  
Sales and Marketing expenses
      334        165  
General and Administrative expenses
      3,236        3,100  
  
 
 
     
 
 
  
Total personnel expenses
   
 
8,618
 
   
 
7,272
 
  
 
 
     
 
 
  
 
16
The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Wages and salaries
      5,144        4,438  
Social security contributions
      1,207        699  
Expenses for pension commitments
      309        258  
Employer contribution to bonus shares
      —         244  
Share-based payments
      1,958        1,632  
  
 
 
     
 
 
  
Total
   
 
8,618
 
   
 
7,272
 
  
 
 
     
 
 
  
The increase in personnel expenses is mainly due to the recruitment of US employees.
Note 12: Financial income (expense)
Our financial income was $1.3 million for the three months ended March 31, 2024, compared to $0.6 million for the three
months
ended March 31, 2023. This item mainly includes the financial income on our financial assets.
Note 13: Commitments
There has been no significant change in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.
Note 14: Relationships with Related Parties
There were no new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.
Note 15: Loss Per Share
Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three months ended March 31, 2024 and 2023, 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 months ended March 31, 2024 and 2023 indicated in number of potential shares:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Non-employee
warrants
      244,693        251,693  
Stock options
      7,388,016        5,318,569  
Restricted stock units
      2,064,035        1,583,938  
Prefunded warrants
      28,276,331        28,276,331
Note 16: Events after the Close of the Period
The Company evaluated subsequent events that occurred after March 31, 2024, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on May 7, 2024 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
On April 22, 2024, the Company moved its headquarters to 107 Avenue de la République in Châtillon in France, which is subject to ratification by the shareholders of the Company at the annual general meeting on May 16, 2024.
 
 
17

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, 2023, included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 7, 2024, 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, our proprietary method of delivering biologically active compounds to the immune system through intact skin using 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. Viaskin 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 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, if approved.

Our most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy, as well as two planned Phase 3 supplementary safety studies, one in peanut-allergic children ages four through seven, and one in peanut-allergic toddlers, ages one through three.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the 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.

Business trends and Results of Operations

Comparison of the Three Months Ended March 31, 2024 and 2023

The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended March 31, 2024 and 2023.

 

18

     Three months ended
March 31,		                
     2024      2023      $ change      % change  

Operating income

    $ 1,407      $ 2,194        (787 )       (36 %) 

Operating expenses

            

Research and development expenses

      (21,403 )       (16,037 )       (5,366 )       33 % 

Sales and marketing expenses

      (758 )       (434 )       (324 )       75 % 

General and administrative expenses

      (7,804 )       (6,889 )       (915 )       13 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total Operating expenses

      (29,964 )       (23,359 )       (6,605 )       28 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Financial income

      1,261        605        656        108 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Income tax

      (48 )       —         (48 )       —   
  

 

 

     

 

 

     

 

 

     

 

 

  

Net loss

    $ (27,345 )     $ (20,561 )       (6,785 )       33 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Basic/diluted Net loss per share attributable to shareholders

    $ (0.28 )     $ (0.22 )       

Operating Income

The following table summarizes our operating income during the three months ended March 31, 2024 and 2023:

 

     Three months ended
March 31,		      $ change      % change  
     2024      2023                

Sales

      —         —         —         —   

Other income

      1,407        2,194        (787 )       (36 %) 

Research tax credit

      1,407        1,765        (358 )       (20 )% 

Other operating income

      —         429        (429 )       (100 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total operating income

      1,407        2,194        (787 )       (36 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Until the end of 2023, our operating income was composed of both the French research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively generated by the French research tax credit.

Operating Expenses

Since inception, our operating expenses have consisted primarily of research and development activities, and to a lower extent general and administration sales and marketing activities.

 

19

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended March 31, 2024 and 2023:

 

     Three Months Ended
March 31,		                
Research and Development expenses    2024      2023      $ change      % change  

External clinical-related expenses

      14,026        10,471        3,555        34 % 

Employee-related costs

      4,278        3,319        959        29 % 

Share-based payment expenses

      770        687        83        12 % 

Depreciation, amortization and other costs

      2,329        1,559        770        69 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total Research and Development expenses

      21,403        16,037        5,366        33 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Research and Development expenses increased by $5.4 million for the three months ended March 31, 2024, compared to the three

months ended March 31, 2023, primarily due to the increase in external clinical-related expenses for $3.6 million, driven by progress on patient enrollment in VITESSE Phase 3 clinical trial.

Employee-related costs, excluding share-based payments, increased by $1.0 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023 due to the recruitment of employees to support research and development activities mainly on the VITESSE trial.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2024 and 2023:

 

     Three Months Ended
March 31,		      $ change      % change  
Sales and Marketing expenses    2024      2023  

Personnel expenses (incl. share-based payment expenses)

      334        165        169        102 % 

External professional services and other costs

      424        269        155        58 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total Sales and Marketing expenses

      758        434        324        75 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Sales and marketing expenses have increased by $0.3 million during the three months ended March 31, 2024, compared the three months ended March 31, 2023 to support pre-commercialization activities for Viaskin Peanut in North America.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the three months ended March 31, 2024 and 2023:

 

     Three Months Ended
March 31,		      $ change      % change  
General and Administrative expenses    2024      2023  

External professional services

      2,433        1,706        726        43 % 

Employee-related costs

      2,080        2,190        (111 )       (5 %) 

Share-based payment expenses

      1,157        910        247        27 % 

Depreciation, amortization and other costs

      2,135        2,082        53        3 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Total General and Administrative expenses

      7,804        6,889        915        13 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

General and Administrative expenses increased by $0.9 million for the three months ended March 31, 2024, compared to the three months ended March 31, 2023 as a result of external professional services incurred to prepare financing activities as well to perform recruitments.

 

20

Financial income (expense)

Our financial income was $1.3 million for the three months ended March 31, 2024, compared to a financial income of $0.6 million for the three months ended March 31, 2023. This item mainly includes the financial income on our financial assets.

This item mainly includes the financial income on our financial assets, reflecting the rise of Euro short term monetary rates between 2023-Q1 (€STER = 1.89% on December 31, 2022) and 2024-Q1 (€STER = 3.88% on December 31, 2023), where our excess cash is invested.

Income tax

Our income tax profit for the three months ended March 31, 2024 was $48 thousand. We did not have any income tax profit or expense for the three months ended March 31, 2023.

Net loss

Net loss was $27.3 million for the three months ended March 31, 2024, compared to $20.6 million for the three months ended March 31, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.28 and $0.22 for the three months ended March 31, 2024 and 2023, respectively.

Liquidity and Capital Resources

Financial Condition

On March 31, 2024, we had $101.5 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023. Based on its current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations until December 31, 2024.

As of the date of filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern.

We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $34.7 million and $20.8 million for the three months ended March 31, 2024 and 2023, respectively. For the three months ended March 31, 2024, we recorded a net loss of $27.3 million. Our net cash flows provided by financing activities was $(0.1) million during the three months ended March 31, 2024 compared to a nil amount during the three months ended March 31, 2023. Our net cash flows used in investing activities was $(2.1) million during the three months ended March 31, 2024, including revamping of the new headquarter for $(1.3) million, compared to $(0.1) million during the three months ended March 31, 2023.

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.

We fund short-term cash requirements primarily from payments associated with research tax credits (Crédit d’Impôt Recherche).

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 Platform and for working capital and other general corporate purposes.

 

21

We intend to seek additional capital as we prepare for the launch of 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.

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.

Operating leases

At the date of filing, our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023 and represents a $4.5 million cash requirement as of March 31, 2024 until March, 2033. The move of the corporate headquarters to Châtillon, France is subject to ratification by the shareholders of the Company at the annual general meeting on May 16, 2024.

The lease agreement for the office occupying 4,470 square meter facility in Montrouge, France, signed on March 3, 2015, with an effective date of August 1, 2025, expires on May, 2024. Associated lease termination costs were reflected in the Company’s financial accounts in the Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024.

At the date of filing, our primary U.S. office is located in Warren, New Jersey. In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. The Warren office represent a $1.8 million cash requirement as of March 31, 2024 which expires December 31, 2029.

We also have facilities in North America that were intended to support our U.S. operations. We lease 5,799 square feet in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months.

The Company transitioned to its new offices location in Warren NJ and Châtillon France over the end of the first quarter of 2024. Leases from prior offices located in Basking Ridge NJ and Montrouge, France offices were still active at the time of filing.

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. As of December 31, 2023, expenses associated with the ongoing trials amounted globally to $114.4 millions, and we had non-cancellable contractual obligations with CRO until year ended 2025 amounting to $64.4 millions.

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

Summary Statement of Cash Flows

The table below summarizes our sources and uses of cash for the three months ended March 31, 2024 and 2023.

 

     Three months ended
March 31,		                
(Amounts in thousands of U.S. Dollars)    2024      2023      $ change      % of
change		  

Net cash flow provided by (used in) operating activities

      (34,692 )       (20,841 )       (13,851 )       66 % 

Net cash flow provided by (used in) investing activities

      (2,132 )       42        (2,174 )       (5,176 %) 

Net cash flow provided by (used in) financing activities

      (62 )       (14 )       (47 )       328 % 

Effect of exchange rate changes on cash and cash equivalents

      (2,957 )       3,909        (6,866 )       (176 %) 
  

 

 

     

 

 

     

 

 

     

 

 

  

Net (decrease) increase in cash and cash equivalents

      (39,842 )       (16,905 )       (22,937 )       136 % 
  

 

 

     

 

 

     

 

 

     

 

 

  

Operating Activities

Our net cash flows used in operating activities were $34.7 million and $20.8 million during the three months ended March 31, 2024 and 2023, respectively. The variance of $13.9 million is mainly driven by the increase in (1) external clinical-related expenses by $3.7 million, (2) R&D activities to support clinical trials progress through Regulatory Affairs, Medical Affairs, Manufacturing platform and Supply activities by $6.4 million and (3) internal employees’ compensation increase by $2.5 million with 18 additional employees.

 

22

Investing Activities

Our net cash flows used in investing activities was $(2.1) million during the three months ended March 31, 2024, including revamping of the new offices in Châtillon, France for $(1.3) million, compared to $(0.1) million during the three months ended March 31, 2023.

Smaller Reporting Company Status

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

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are a smaller reporting company as defined by Rule 12b-2 of the 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 March 31, 2024, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

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

Limitation on Effectiveness of Controls and Procedures

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

 

23

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 Quarterly Report.
Item 1A. Risk Factors
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 in 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.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the three months ended March 31, 2024, we issued the following unregistered securities:
 
  •  
On March 23, 2024, the issuance of an aggregate of 2,599 ordinary shares to US and
non-US
employees 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
During the three months ended March 31, 2024, none of our directors and officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted or terminated any contracts, instructions or written plans for the purchase or sale of the Company’s securities.
 
24

Item 6. Exhibits.

Exhibit Index

 

          Incorporated by Reference  

Exhibit

   

Description

    Schedule/ Form      File Number      Exhibit      File Date  

3.1

    By-laws (status) of the registrant (English translation)            

31.1

    Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended            

31.2

    Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended            

32.1*

    Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended            

101.INS

    XBRL Instance Document            

101.SCH

    XBRL Taxonomy Extension Schema Document            

101.CAL

    XBRL Taxonomy Extension Calculation Linkbase Document            

101.DEF

    XBRL Taxonomy Extension Definition Linkbase Document            

101.LAB

    XBRL Taxonomy Extension Labels Linkbase Document            

101.PRE

    XBRL Taxonomy Extension Presentation Linkbase Document            

104

    Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101.            

 

*

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

 

25

SIGNATURES

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

 

    DBV Technologies S.A.
    (Registrant)
Date: May 7, 2024     By:  

/s/ Daniel Tassé

    Daniel Tassé
    Chief Executive Officer
    (Principal Executive Officer)
Date: May 7, 2024     By:  

/s/ Virginie Boucinha

    Virginie Boucinha
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

26

Exhibit 3.1

BY-LAWS

(updated by decision of the CEO on March 23, 2024)

DBV Technologies

Limited Company with share capital of € 9,643,436.90

177-181 avenue Pierre Brossolette - 92120 Montrouge, France

Nanterre Trade and Companies Register No. 441 772 522

 

1

I. - CHARACTERISTIC FEATURES OF THE COMPANY

Article 1 - Form

The Company was incorporated in the form of a French Limited Company (Société Anonyme) with a Board of Directors.

Article 2 - Name

The name of the Company is: “DBV Technologies”.

Article 3 - Registered office

The registered office is located at: 177-181 avenue Pierre Brossolette - 92120 Montrouge, France

Article 4 - Corporate Purpose

The Company’s corporate purpose in France and in all countries is:

 

  •  

the development of any innovative medical products, including any drugs, or diagnostic or treatment products;

 

  •  

the study, research, development, industrial manufacturing, and marketing of said products;

 

  •  

the use and development of any patents or licenses relating to these products, and generally speaking any commercial, investment or real estate, financial or other transactions that are directly or indirectly related to the corporate purpose in whole or in part, or to any other similar or related purpose, and that may promote the operation and commercial development of the Company.

Article 5 - Term

The Company’s term is ninety-nine years as from its registration in the Trade and Companies Register.

Article 6 - Share capital

The share capital has been set at € 9,643,436.90.

It is divided into 96,434,369 ordinary shares with a par value of 10-euro cents (€0.10) each. All of the shares have been fully subscribed, and their full amount paid up in cash.

Article 7 - Changes to the share capital

I. The share capital may be increased either via the issue of new shares, or by increasing the par value of the existing shares.

 

2

The new shares will be paid for in cash, or via a contribution in kind, offset against liquid and due receivables, or via the incorporation of profits, reserves, or share premiums into the share capital, either as the result of a merger or demerger, or following the exercise of a right attached to transferable securities granting entitlement to the share capital, including payment of the corresponding amounts, where applicable.

The new equity securities will be issued either at their par value, or at that amount plus a share premium.

Only the Extraordinary General Meeting of Shareholders has the power to decide on increasing the share capital, based on a report from the Board of Directors containing the disclosures required by law.

However, the Extraordinary General Meeting of Shareholders may delegate this power to the Board of Directors under the conditions determined by law. The Board of Directors has the requisite powers to perform a capital increase in one or several installments, to determine its terms and conditions, to record its completion, and to amend the By-Laws accordingly within the limits of the powers so granted by the Extraordinary General Meeting of Shareholders.

If the General Meeting of Shareholders decides to increase the share capital, it may delegate the powers required to perform the transaction to the Board of Directors.

If a delegation of power or of authority is used, the Board of Directors will draw up a supplementary report at the next Ordinary General Meeting of Shareholders.

If the capital increase is performed via the incorporation of profits, reserves, or share premiums, the Extraordinary General Meeting of Shareholders will take decisions under the quorum and majority conditions provided for Ordinary General Meetings of Shareholders. In this case, it may decide that rights amounting to fractional shares may neither be traded nor transferred, and that the corresponding equity securities must be sold. The proceeds from the sale will be allocated to the holders in proportion to their rights.

A capital increase by increasing the par value of the shares can only be decided with the shareholders’ unanimous consent, except if it results from the incorporation of profits, reserves, or share premiums into the share capital.

Shareholders will have a preferential right to subscribe to the cash shares issued in order to perform a capital increase, in proportion to the number of shares that they hold. The shares purchased as a result of exercising this right will be shares in the same class as the one for the shares giving rise to said right, together with the shares resulting from the purchase of other transferable securities than shares.

The shareholders may sell all or some of their subscription rights throughout the subscription period. These rights will be tradable if they are stripped from shares that are themselves tradable. Otherwise, they may be sold under the same conditions as the actual shares.

Shareholders may waive their preferential subscription right on an individual basis.

The Extraordinary General Meeting of Shareholders that decides on the capital increase may waive the preferential subscription right under the conditions and limits determined by law, and rule to that effect on the reports prepared by the Board of Directors and the Statutory Auditors under the conditions determined by the laws and regulations in effect.

If the Extraordinary General Meeting of Shareholders, or the Board of Directors in the event of a delegation of authority, has expressly decided to do so, any shares that have not been subscribed on an irrevocable basis will be allotted to shareholders who subscribed to a higher number of shares on a revocable basis than the number to which they were able to subscribe on a preferential basis, in proportion to the subscription rights that they hold, and within the limits of their request, in any event.

 

3

If, for any reason, subscriptions have not absorbed the full amount of the capital increase, the Board of Directors may use the options provided for below, or only some of them, in the order that it determines:

 

(i)

limiting the capital increase to the amount of the subscriptions, subject to the general condition that it amounts to at least three quarters of the increase decided upon, and that this option was not expressly excluded by the Extraordinary General Meeting of Shareholders at the time of issue;

 

(ii)

allocating the balance of the shares if the Extraordinary General Meeting of Shareholders has not decided otherwise;

 

(iii)

opening the subscription process to the public if the Extraordinary General Meeting of Shareholders has expressly authorized it.

If subscriptions have not absorbed the entire capital increase following the exercise of these options, or three-quarters of the increase in the case provided for under (i) above, the capital increase will not be performed.

However, the Board of Directors may automatically limit the capital increase to the amount raised in all cases where the unsubscribed shares account for less than 3% of the capital increase.

In the event of a capital increase with or without preferential subscription rights, the Extraordinary General Meeting of Shareholders may provide that the number of securities may be increased by up to 15% of the initial issue, at the same price as the one used for the initial issue within a period of thirty days following the close of the subscription period.

If the capital increase creates fractions of shares, shareholders who have an insufficient number of subscription or allotment rights must make arrangements to purchase or sell the rights required to obtain the delivery of a whole number of new shares.

II. The Extraordinary General Meeting of Shareholders (or the Board of Directors in the event of a delegation of authority) may also authorize or decide on a capital decrease, subject to the rights of creditors, where applicable.

Decreasing the share capital below the legal limit can only be decided under the condition precedent of a capital increase intended to return the share capital to an amount that is at least equal to the minimum legal threshold, unless the Company turns itself into a company with another legal form. Otherwise, any interested party may apply to the courts to have the Company wound up. The court may not order the Company to be wound up if the amount of the share capital has been restored to the statutory minimum by the day when it rules on the substance of the case.

Article 8 - Financial year

The financial year runs from January 1 to December 31.

II. - ADMINISTRATION OF THE COMPANY

Article 9 - Executive Management exercise method

The executive management of the Company is the responsibility either of the Chairman of the Board of Directors or of another individual appointed by the Board of Directors bearing the title of Chief Executive Officer.

The Board of Directors chooses between the two Executive Management exercise methods based on the unanimous vote of all of its members.

Where responsibility for the Company’s Executive Management is held by the Chairman of the Board of Directors, the following provisions concerning the role of Chief Executive Officer apply.

 

4

A. The Board of Directors

Article 10 - Composition of the Board of Directors

The Company is governed by a Board of Directors that consists of between 3 and 18 directors.

The Directors are appointed by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.

The term of office for the Directors appointed during the term of the company is three (3) years. This term expires at the end of the meeting convened to approve the financial statements for the year just ended, and which is held in the year during which their term of office expires.

By way of exception and in order to allow exclusively for the implementation or maintenance of the staggered terms of office of Directors, the ordinary General Meeting of Shareholders may appoint one or more members of the Board for a term of two (2) years or one (1) year.

The Directors may be dismissed at any time and without any good reason by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.

The number of Directors aged over eighty cannot exceed one third of the Board members.

Article 11 - Board Discussions

The Board of Directors meets as often as is required by the Company’s interests at the invitation of the Chairman of the Board of Directors, at the registered office or the place specified in the notice of meeting. The invitation may be issued by any means five days in advance: it may also be issued orally and immediately if all of the Directors and non-voting Board members agree.

The Board of Directors may also make decisions by written consultation of the directors under the conditions provided by law.

The Board of Directors may also, at the discretion of its Chairman, make the following decisions by written consultation:

 

•  

cooptation following (i) a death, (ii) a resignation, (iii) when the number of directors has fallen below the statutory minimum, or (iv) when the gender balance is no longer respected;

 

•  

authorization of sureties, endorsements and guarantees given by the Company;

 

•  

transfer of the registered office in the same department;

 

•  

amendment of the articles of association to bring them into line with the conditions laid down by law;

 

•  

convening of the General Meeting.

In the event of a written consultation, the Chairman sends to each director, alternatively (i) by registered letter with acknowledgement of receipt, (ii) by e-mail with acknowledgement of receipt, the text of the proposed decisions as well as all documents useful for his information.

The directors have a period of five calendar days (ending at 11:59 p.m., Paris time, on the last day of this period) from the date of dispatch of the draft decisions to express their vote in writing. The reply is sent alternatively (i) by registered letter with acknowledgement of receipt, (ii) by e-mail with acknowledgement of receipt, to the attention of the Chairman of the Board of Directors, at the Company’s registered office, if any.

The Board of Directors may only validly deliberate on a written consultation if at least half of its members have replied within the time limit indicated above.

Decisions are taken by a majority of the votes of the members who have replied, each member having one vote.

 

5

If it has not met for over two months, at least one quarter of the members of the Board of Directors may ask the Chairman to convene the Board based on a determined agenda. The Chief Executive Officer or a Director may also ask the Chairman to convene the Board of Directors based on a determined agenda. The Chairman will be bound by any such requests.

An attendance register will be kept, and minutes will be drawn up following each meeting. The Board may only validly take decisions if at least half of its members are present.

Except where the choice of the method for exercising Executive Management is concerned, decisions will be taken based on a majority vote of the Directors present or represented. The Chairman will have a casting vote in the event that the vote is split.

The Directors and any individuals asked to attend the Board of Directors’ meetings are required to exercise discretion with respect to information of a confidential nature, and which is provided as such by the Chairman of the Board of Directors.

Article 12 - The Board’s powers

The Board of Directors determines the Company’s guidelines, and ensures their implementation. Subject to the powers specifically assigned to General Meetings of Shareholders, and within the limits of the corporate purpose, the Board will deal with any matter involving the proper operation of the Company, and settle any matters concerning it through its discussions.

The Board of Directors carries out the controls and verifications that it considers appropriate. Every Director will receive all of the information required to fulfill their assignment, and may ask for the disclosure of any documents that they consider useful.

Article 13 - The Chairman of the Board of Directors

The Board of Directors elects a Chairman, who must be a private individual, from among its members, and determines their remuneration, in accordance with applicable law. The Chairman is appointed for a period that may not exceed the length of their term of office as a Director. They are eligible for re-election. The Board of Directors may dismiss the Chairman at any time. Any provisions to the contrary will be considered void.

No one aged 75 or over may be appointed as Chairman. If the incumbent Chairman reaches this age during a financial year, their duties will automatically end following the Ordinary General Meeting of Shareholders convened to approve the financial statements for that financial year.

The Chairman organizes and directs the work undertaken by the Board, and accounts for it at the General Meeting of Shareholders. They ensure that the Company’s bodies operate properly, and especially that the Directors are in a position to fulfill their assignment.

Article 14 - Non-Voting Board Members

The General Meeting of Shareholders may appoint one or two non-voting Board members for the Company who are private individuals, regardless of whether they are shareholders; they will be aged 65 at most on the day of their appointment.

Non-voting Board members are appointed for a period of two (2) years. Their assignment ends after the General Meeting of Shareholders that has approved the financial statements for the year just ended, and held in the year during which their term of office expires.

Non-voting Board members do not receive any remuneration. They may receive allowances determined by the Board of Directors in order to reimburse the expenses that they are required to incur as part of the normal performance of their duties. If the Board delegates a specific assignment to the non-voting Board members or to one of them, they may allocate them an allowance in proportion to the importance of the assignment entrusted to them, as well as a budget for performing said assignment. Non-voting Board members are invited to all of the Board of Directors’ meetings and to all of the General Meeting

 

6

of Shareholders, and take part in the discussions in an advisory capacity. Non-voting Board members perform a general and permanent advisory and supervisory role at the Company. However, they may not interfere in the management of the Company under any circumstances, or, in general, replace its legal bodies.

B. The Executive Management

Article 15 - Chief Executive Officers and Deputy Chief Executive Officers

The executive management of the Company is the responsibility of a private individual appointed by the Board of Directors bearing the title of Chief Executive Officer, under the Company’s responsibility.

The Board of Directors may appoint one or more private individuals responsible for assisting the Chief Executive Officer, who will bear the title of Deputy Chief Executive Officer, on the recommendation of the Chief Executive Officer. The number of Deputy Chief Executive Officers cannot exceed five.

The Chief Executive Officer may be dismissed by the Board of Directors at any time. The same applies to the Deputy Chief Executive Officers, on the recommendation of the Chief Executive Officer. If the dismissal is not on justified grounds, it may result in the payment of damages and interest.

Where the Chief Executive Officer ceases, or is otherwise prevented from performing their duties, the Deputy Chief Executive Officers will retain their positions and their assignments until a new Chief Executive Officer is appointed, unless the Board decides otherwise.

The Board of Directors determines the compensation paid to the Chief Executive Officer and the Deputy Chief Executive Officers, in accordance with applicable law.

Article 16 - Powers of the Chief Executive Officer and Deputy Chief Executive Officers

The Chief Executive Officer is granted very extensive powers to act in the Company’s name in all circumstances. They exercise the powers within the limit of the corporate purpose, and subject to those that the law and these By-Laws expressly assign to General Meeting of Shareholders and to the Board of Directors.

They represent the Company in its dealings with third parties. The Company will be committed even by the Chief Executive Officer’s actions that do not relate to the corporate purpose, unless it proves that the third party was aware that the action exceeded that purpose, or could not ignore this fact in view of the circumstances. The sole publication of the By-Laws does not amount to sufficient proof.

The Board of Directors determines the scope and term of the powers granted to the Deputy Chief Executive Officers, with the Chief Executive Officer’s consent. The Deputy Chief Executive Officers have the same powers as the Chief Executive Officer where third parties are concerned.

III. - GENERAL MEETING OF SHAREHOLDERS

Article 17 - General Meeting of Shareholders

The duly constituted General Meeting of Shareholders represents the entire body of shareholders.

Its decisions, which are taken in accordance with the law and the By-Laws, are binding on all of the shareholders, even if they are absent, disagree, or are incapable.

There are three forms of meetings, depending on the purpose of the resolutions put forward:

 

  •  

Ordinary General Meetings;

 

7

  •  

Extraordinary General Meetings;

 

  •  

Special Meetings that bring together the holders of shares in a given class.

Article 18 - Invitations

The Meetings are convened by the Board of Directors. They may also be convened by the Statutory Auditor or by a court representative, under the conditions and in accordance with the procedures provided for by law.

Meetings are convened by the liquidator(s) during the liquidation period.

The Meetings are held at the registered office or at any other location specified in the notice of meeting.

A notice of meeting is published in the Bulletin des Annonces Légales Obligatoires (French Official Gazette, or BALO) at least thirty-five days before a Meeting is held. In addition to the information relating to the Company, the notice specifies the agenda for the Meeting, and the wording of the draft resolutions that will be put forward. Requests to enter points or draft resolutions on the agenda must be addressed to the Company under the conditions provided for by the regulations in effect.

The Meetings are held at the registered office or at any other location specified in the notice of meeting.

Subject to specific legal provisions, the invitation is issued at least fifteen days before the date of the Meeting by a notice inserted in a legal gazette published in the Department where the registered office is located, as well as in the BALO.

The holders of registered shares must be convened under the conditions provided for by the regulations in force.

The notice of meeting must also specify the conditions under which shareholders may vote by post, and the places where, and terms and conditions according to which, they may obtain postal vote forms.

The notice of meeting may be sent, where applicable, with a proxy form and a postal voting form, under the conditions specified in Article 21 of these Articles of Association, or with a postal voting form only, under the conditions specified in Article 21 of these Articles of Association.

Where a Meeting has been unable to take decisions as a result of failing to achieve the quorum required, a second Meeting will be convened, subject to specific legal provisions, at least ten days in advance, in the forms provided for by the regulations in effect.

Article 19 - Agenda

The agenda for Meetings will be prepared by the person convening the meeting.

One or several shareholders, who represent at least the percentage of the share capital specified by law, and acting in accordance with the legal conditions and timeframes, have the option to request the inclusion of points or draft resolutions on the agenda for the Meeting, via registered letter with a request for acknowledgment of receipt.

The Meeting may not discuss an issue that has not been entered on the agenda, which cannot be altered at the time of the second invitation. However, it may dismiss one or several members of the Board of Directors, and replace them in all circumstances.

Article 20 - Participation of Shareholders in Meetings

Any shareholder may participate, personally or by proxy, in the meetings upon proof of identity and ownership of his or her shares, in accordance with the procedures provided for by the laws and regulations in force.

 

8

Article 21 - Postal and proxy voting

Postal voting is carried out in accordance with the terms and conditions laid down by the legal and regulatory provisions. In particular, any shareholder may send postal voting forms either in paper form or, if the Board of Directors decides to do so and publishes the decision in the notice of meeting, by electronic means, before the meetings. Proxy forms may be sent either in paper form or by electronic means before the meetings.

If the Board of Directors decides at the time of convening the meeting to allow the transmission of voting or proxy forms by electronic means, the electronic signature of these forms may result from a reliable process for identifying the shareholder, guaranteeing its link with the remote form to which its signature is attached. The vote thus expressed before the meeting by this electronic means, as well as the acknowledgement of receipt given, will be considered as non-revocable writings and opposable to all. The proxy is however revocable in the same way as those required for the appointment of the proxy. In the event of a transfer of ownership of securities occurring before midnight (Paris time) on the second business day preceding the meeting, the Company will invalidate or modify accordingly, as the case may be, the proxy or the vote cast before the meeting by this electronic means.

Article 22 - Attendance sheet

An attendance sheet containing the information specified by law will be kept at each Meeting.

This attendance sheet, duly initialed by the shareholders present and the proxies, and the shareholders attending via video-conference or another means of telecommunication, in accordance with the legal and regulatory requirements, and to which the powers granted to each representative are appended, together with the postal voting forms, will be certified as accurate by the Meeting Bureau.

The Meetings will be chaired by the Chairman of the Board of Directors. Otherwise, the Meeting will elect its own Chairman.

The tellers’ duties will be performed by two shareholders who are present and agree to do so, and who represent the highest number of votes, both on their own behalf and as proxies.

The Bureau formed in this way will appoint a secretary, who may be chosen from outside the shareholders.

Article 23 - Voting rights attached to shares

The voting right attached to the shares is proportional to the percentage of the total share capital that they represent. Each equity share or dividend share will grant entitlement to one vote. Fully paid-up shares for which proof can be provided that they have been registered in the name of the same shareholder for at least two years do not benefit from double voting rights.

Article 24 - Minutes

The decisions taken at the Meetings will be recorded in minutes that are drawn up in a special ledger held at the registered office, and signed by the members of the Bureau.

Copies or excerpts of the minutes of the decisions will be certified either by the Chairman of the Board of Directors or by the Meeting Secretary. They will be validly certified by the liquidator(s) in the event of liquidation proceedings.

Article 25 - Disclosure of documents

Any shareholder has the right to obtain disclosure of, and the Board of Directors is required to send or make available to them, the documents required to enable them to form an opinion in full knowledge of the facts, and to make an informed judgment on the Company’s management and operations.

The nature of these documents, and the conditions for sending them or making them available to the shareholders are determined by the regulations in effect.

 

9

Every shareholder or their representative may seek the assistance of an expert registered on one of the lists drawn up by the courts, in order to exercise their right of disclosure.

The exercise of the right of disclosure entails the right to take copies, except where records are concerned.

Article 26 - Ordinary General Meeting of Shareholders

The Ordinary General Meeting of Shareholders takes all of the decisions that exceed the powers of the Board of Directors and which do not fall within the remit of the Extraordinary General Meeting of Shareholders.

The Meeting is convened at least once a year, within a period of six months following the end of each financial year, in order to approve the financial statements for that year, subject to this period being extended by an order from the Presiding Judge of the Commercial Court ruling at the request of the Board of Directors.

The Meeting is convened on an extraordinary basis every time that this appears to be in the Company’s interests.

When convened for the first time, the Ordinary General Meeting of Shareholders may only validly deliberate if the shareholders present, represented, or who have voted by post hold at least one fifth of the shares to which voting rights are attached.

No quorum is required if the meeting is convened for a second time and the original agenda has not been amended.

The Ordinary General Meeting of Shareholders decides by a majority of the votes expressed by the shareholders present, represented or voting by mail. The expressed votes do not include those attached to shares for which the shareholder has not taken part in the vote, has abstained or has voted blank or null.

Article 27 - Extraordinary General Meeting of Shareholders

Only the Extraordinary General Meeting of Shareholders is authorized to amend all of the provisions of the By-Laws, and to specifically decide on turning the Company into a company with another legal form. It cannot, however increase the shareholders’ undertakings, except in the case of transactions resulting from a duly executed reverse share split.

The Extraordinary General Meeting of Shareholders may only validly deliberate if the shareholders present, represented or who have voted by post hold at least one quarter of the shares with voting rights at the time of the first invitation, and one fifth of the shares with voting rights at the time of the second invitation. If the second quorum is not achieved, the second Meeting may be postponed to a date no later than two months after the date on which it was convened.

The Meeting passes resolutions based on a two-thirds majority vote expressed by the shareholders who are present, represented, or have voted by post, or who are attending the Meeting via video-conference or another means of telecommunication, in accordance with the legal and regulatory provisions.

As a legal exemption to the above provisions, a General Meeting of Shareholders that decides on a capital increase via the capitalization of reserves, profits, or share premiums may pass resolutions under the same quorum and majority conditions as an Ordinary General Meeting of Shareholders.

Furthermore, where the Extraordinary General Meeting of Shareholders is required to discuss the approval of a contribution in kind or the granting of a particular benefit, the shares held by the individual making the contribution or the beneficial owner will not be taken into account to calculate the majority. The individual making the contribution or the beneficial owner will not have a vote, either on their own behalf, or as a proxy.

 

10

Article 28 - Special Meeting

If there are several share classes, no change may be made to the rights attached to shares in one of these classes without a due vote at an Extraordinary General Meeting of Shareholders open to all shareholders and, furthermore, without an equally compliant vote at a Special Meeting open only to the holders of shares in the class in question.

Special Meetings may only validly discuss matters if the shareholders present, represented, who have voted by post, or who are attending the Meeting via video-conference or via another means of telecommunication in accordance with the legal and regulatory provisions, hold at least one third of the shares with voting rights, where an amendment to those rights is planned, on the first invitation, and one fifth of the shares on the second invitation. Otherwise, the second Special Meeting may be postponed to a date no later than two months after the date on which it was convened.

Special Meetings pass resolutions based on a two-thirds majority of the expressed votes of the shareholders present or represented.

IV. - THE COMPANY’S SECURITIES

Article 29 - Payment for the shares

At least 25% of the par value of shares subscribed in cash must be paid at the time of subscription, together with the full share premium, where applicable.

The balance must be paid in one or several installments, as called by the Board of Directors, and within a period of five years from the date on which the capital increase was finalized.

Calls for funds are made known to the shareholders via a notice published in the BALO fifteen (15) days in advance.

If the shareholder does not make the required payments on the amount of the shares to which they have subscribed at the times determined by the Board of Directors, these payments will automatically bear interest payable to the Company at the legal rate determined in Article L. 313-2 of the French Monetary and Financial Code, as from the end of the month following the date when they are due, without any requirement for a court application or letter of notice. Furthermore, shares for which the required payments have not been made at the end of a period of 30 days as from the sending of a letter of notice to the defaulting shareholder, to which no reply has been received, will no longer grant the right to attend General Meetings of Shareholders and to vote at those Meetings, and will be deducted from the quorum calculation. The right to dividends, and the preferential right to subscribe to capital increases attached to the shares will be suspended. These rights will be recovered once the capital and interest amounts due have been paid. The shareholder may then request the payment of dividends that have not expired, and exercise their preferential subscription right, if the determined timeframe for exercising that right has not expired.

The share capital must be fully paid up before any issue of new shares to be paid for in cash.

Article 30 - Form of the shares - Management of the securities accounts

The shares may be in registered or bearer form, if the legislation allows, depending on the shareholder’s choice.

Issued shares give rise to a registration in individual accounts in the name of each shareholder opened by the Company or any authorized intermediary. These accounts are held under the conditions and in accordance with the procedures provided for by the legal and regulatory provisions.

In order to identify the owners of bearer shares, the company may, under the conditions provided for by the legal and regulatory provisions in force, request, at any time, information concerning the owners of its shares and securities conferring immediate or future voting rights at its own General Meetings of Shareholders.

 

11

Article 31 - Transfer of the shares

Shares registered on an account are transferred from account to account.

Cash shares are freely tradable as from the completion of the capital increase. Shares resulting from contributions are freely tradable as from the completion of the capital increase, i.e. the date of the Meeting or of the meeting of the Board of Directors acting on a delegation of authority, which approved the contributions, in the event of a contribution in kind during the term of the company.

The transfer of ownership will result from their registration on the purchaser’s account, on the date and under the conditions determined by law and the applicable regulations, where applicable.

The shares will be freely tradable, subject to the provisions provided for by law.

Article 32 - Crossing of thresholds

Any private individual or legal entity referred to in Articles L. 233-7, L. 233-9, and L. 223-10 of the French Commercial Code who comes to directly or indirectly hold a number of shares representing a percentage of the Company’s share capital or voting rights higher than or equal to 2.5% or a multiple of that percentage, either on a stand-alone basis or in concert, must inform the Company of the total number of shares, voting rights, and securities granting access to the share capital or to voting rights immediately or in the future that they hold, via registered letter with a request for an acknowledgment of receipt sent to the registered office within a period of four trading days, prior to the market close as from the point when they crossed said percentage threshold(s).

The disclosure obligation provided for above also applies under the same conditions when each threshold mentioned above is crossed downwards.

If they have not been reported under the conditions specified above, shares or voting rights that exceed the percentage that should have been reported will be stripped of their voting rights at General Meetings of Shareholders at any Meeting that may be held until the expiry of a two-year period following the date when the notice of interest was made compliant, in accordance with Article L. 233-14 of the French Commercial Code, if a failure to report has been observed, and if one or several shareholders holding an interest of at least 2.5% have made a request recorded in the minutes of the General Meeting of Shareholders.

The above reports will apply notwithstanding the reports on the crossing of thresholds provided for by the legal or regulatory provisions in effect.

Article 33 - Rights and obligations attached to the shares

Each share entitles the holder to a share in the Company’s profits and assets, in proportion to the amount of capital that it represents.

Furthermore, each share entitles the holder to vote and be represented at General Meetings of Shareholders under legal and statutory provisions.

Shareholders will only be liable up to the amount of the par value of the shares that they hold; any calls for funds above that amount are prohibited.

Ownership of a share automatically entails adherence to the Company’s By-Laws and to the decisions of the General Meeting of Shareholders.

Heirs, creditors, assigns, or other representatives of a shareholder will not be entitled to request seizure of the Company’s assets or securities, or ask for them to be shared out or sold at auction, nor interfere in administrative acts relating to the Company in order to exercise their rights; they must refer to the company records and to the resolutions of the General Meeting of Shareholders.

 

12

Whenever it is necessary to hold several shares in order to exercise a given right, such as in the case of an exchange, reverse share split or allotment of shares, or an increase or decrease in the share capital, or a merger or other corporate transaction, the holders of single shares, or of a lower number of shares than required, may only exercise these rights if they personally arrange for the consolidation, and potentially the purchase or sale of the shares required.

However, in the event of the exchange of securities following a merger or demerger transaction, a capital decrease, a reverse share split or share split, and the mandatory conversion of bearer shares to registered shares, or of the distribution of securities charged to the reserves relating to a capital decrease, or the distribution or allotment of bonus shares, based solely on a decision by the Board of Directors, the Company may sell securities that the beneficiaries have requested to be delivered to them, as long as it has carried out the publication formalities provided for in the regulations at least two years beforehand.

As from the sale, the old securities or the old rights to distributions or allotments will be canceled, as and when required, and their holders will only be able to claim the cash allocation of the net proceeds of the sale of the unclaimed securities.

Article 34 - Beneficial & Bare ownership

The shares are indivisible as regards the Company.

Joint owners of shares are required to have themselves represented to the Company by just one of them, who will be considered as the sole owner, or by a single proxy; in the event of disagreement, the single proxy may be appointed by a court at the request of the first joint owner to do so.

Unless the Company has been notified of an agreement to the contrary, the beneficial owners of shares will validly represent the bare owners with the Company. Voting rights will be held by the beneficial owner at Ordinary General Meetings of Shareholders and by the bare owner at Extraordinary General Meetings of Shareholders.

Unless otherwise agreed between the parties, the preferential subscription right attached to securities belongs to the bare owner where the shares are encumbered by a usufruct interest.

V. - COMPANY FINANCIAL STATEMENTS

Article 35. - Preparation and approval of the company financial statements

 

a)

The Board of Directors will draw up an inventory and the annual financial statements at the end of each financial year, and will then prepare the management report.

Where applicable, the Board of Directors will prepare and publish the consolidated financial statements, together with the report regarding the management of the Group.

 

b)

The Ordinary General Meeting of Shareholders will approve the annual company financial statements within a period of six months following the financial year-end, after familiarizing itself with the management report and the report prepared by the Statutory Auditors; the consolidated financial statements and the report regarding the management of the Group will be presented at that Meeting, if required.

All information measures will be taken in compliance with the law and the regulations.

Article 36 - Audit of the financial statements

The financial statements will be audited by one or several incumbent, and, where applicable, alternate Statutory Auditors, under the conditions determined by Articles L. 225-218 of the French Commercial Code.

 

13

Article 37 - Allocation of the amounts available for distribution

Following the approval of the financial statements, and the recording of the existence of amounts available for distribution, the Ordinary General Meeting of Shareholders will determine the share of these amounts allotted to the shareholders in the form of a dividend; this dividend will be charged to the distributable profit for the year as a priority.

The procedures for paying the dividends or interim dividends are determined by the General Meeting of Shareholders.

Write-down differences are not available for distribution.

If required, the Meeting will allocate the non-distributed portion of the profit for the financial year available for distribution in the proportions that it determines, either to one or several reserves, which may be general or special, which remain at its disposal, or to the “retained earnings” account.

Any losses will be carried forward, unless the Meeting decides to offset them against existing reserves.

VI. - LIQUIDATION OF THE COMPANY

Article 38 - Liquidation

Once it has been wound up, the Company will be liquidated under the conditions determined by the French Commercial Code.

Unless the Ordinary General Meeting of Shareholders decides otherwise, the liquidator or liquidators will pursue any ongoing business until it is completed.

The net proceeds of the liquidation, following the settlement of the liabilities and payroll expenses, and repayment to the shareholders of the non-amortized par value of their shares, will be divided between the shareholders, taking the rights of the different share categories into account, where applicable.

Vll - MISCELLANEOUS ITEMS

Article 39 - Powers

All powers will be granted to the bearers of original copies of these By-Laws, or of copies or excerpts certified as original, in order to carry out all formalities.

 

14

Exhibit 31.1

Certification by the Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Daniel Tassé, certify that:

 

1.

I have reviewed this quarterly report on Form 10-Q of DBV Technologies S.A.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 7, 2024      

/s/ Daniel Tassé

      Daniel Tassé
      Chief Executive Officer
      (Principal Executive Officer)

Exhibit 31.2

Certification by the Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Virginie Boucinha, certify that:

 

1.

I have reviewed this quarterly report on Form 10-Q of DBV Technologies S.A.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 7, 2024      

/s/ Virginie Boucinha

      Virginie Boucinha
      Chief Financial Officer
      (Principal Financial and Accounting Officer)

Exhibit 32.1

Certification by the 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

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), Daniel Tassé, Chief Executive Officer of DBV Technologies S.A. (the “Company”), and Virginie Boucinha, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:

1. The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) and Section 15(d) of the Exchange Act, and

2. The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 7, 2024

 

/s/ Daniel Tassé

     

/s/ Virginie Boucinha

Daniel Tassé      Virginie Boucinha
Chief Executive Officer      Chief Financial Officer
(Principal Executive Officer)      (Principal Financial and Accounting Officer)

This certification accompanies the Quarterly Report, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing.

v3.24.1.u1
Cover Page - shares
 3 Months Ended
Mar. 31, 2024
May 07, 2024
Document Information [Line Items]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Mar. 31, 2024  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q1  
Entity Registrant Name DBV TECHNOLOGIES S.A.  
Entity Central Index Key 0001613780  
Entity File Number 001-36697  
Current Fiscal Year End Date --12-31  
Entity Current Reporting Status Yes  
Entity Filer Category Non-accelerated Filer  
Entity Interactive Data Current Yes  
Entity Common Stock, Shares Outstanding   96,434,369
Document Transition Report false  
Document Quarterly Report true  
Entity Shell Company false  
Entity Emerging Growth Company false  
Entity Address, Country FR  
Entity Small Business true  
Entity Incorporation, State or Country Code I0  
Entity Address, Address Line One 177-181 avenue Pierre  
Entity Address, Address Line Two Brossolette  
Entity Address, City or Town Montrouge  
Entity Address, Postal Zip Code 92120  
City Area Code 33  
Local Phone Number 1 55 42 78 78  
Entity Tax Identification Number 00-0000000  
American Depositary Share [Member]    
Document Information [Line Items]    
Title of 12(b) Security American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share  
Trading Symbol DBVT  
Security Exchange Name NASDAQ  
Ordinary Shares [Member]    
Document Information [Line Items]    
Title of 12(b) Security Ordinary shares, nominal value €0.10 per share  
Security Exchange Name NASDAQ  
No Trading Symbol Flag true  
v3.24.1.u1
Condensed Consolidated Statements of Financial Position - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 101,525 $ 141,367
Other current assets 18,037 17,548
Total current assets 119,562 158,915
Non-Current assets    
Property, plant, and equipment, net 12,913 12,623
Right-of-use assets related to operating leases 6,551 5,247
Intangible assets 52 58
Other non-current assets 6,818 6,144
Total non-current assets 26,334 24,071
Total Assets 145,895 182,986
Current liabilities    
Trade payables 18,076 23,302
Short-term operating leases 232 1,144
Current contingencies 3,153 3,959
Other current liabilities 5,023 8,934
Total current liabilities 26,483 37,339
Non-Current liabilities    
Long-term operating leases 6,793 4,526
Non-current contingencies 965 935
Other non-current liabilities 0 0
Total non-current liabilities 7,758 5,461
Total Liabilities 34,241 42,799
Shareholders' equity:    
Ordinary shares, €0.10 par value; 96,434,369 and 96,431,770 shares authorized, and issued as of March 31, 2024 and December 31, 2023, respectively 10,972 10,972
Additional paid-in capital 379,426 377,468
Treasury stock, 262,644 and 222,988 ordinary shares as of March 31, 2024 and December 31, 2023, respectively, at cost (1,325) (1,263)
Accumulated deficit (266,207) (238,862)
Accumulated other comprehensive income 683 742
Accumulated currency translation effect (11,897) (8,871)
Total Shareholders' equity 111,654 140,187
Total Liabilities and Shareholders' equity $ 145,895 $ 182,986
v3.24.1.u1
Condensed Consolidated Statements of Financial Position (Parenthetical) - € / shares
Mar. 31, 2024
Mar. 31, 2023
Treasury stock, common, shares 262,644 222,988
Common Shares [Member]    
Common stock shares par value € 0.1 € 0.1
Common stock shares authorized 96,434,369 96,431,770
Common stock shares issued 96,434,369 96,431,770
v3.24.1.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Operating income $ 1,407 $ 2,194
Operating expenses    
Research and development expenses (21,403) (16,037)
Sales and marketing expenses (758) (434)
General and administrative expenses (7,804) (6,889)
Total Operating expenses (29,964) (23,359)
Loss from operations (28,558) (21,165)
Financial income(expenses) 1,261 605
Loss before taxes (27,297) (20,561)
Income tax (expense) (48) 0
Net loss (27,345) (20,561)
Foreign currency translation differences, net of taxes (3,026) 3,666
Actuarial gains (losses) on employee benefits, net of taxes (59) (82)
Total comprehensive loss $ (30,429) $ (16,977)
Basic Net loss per share attributable to shareholders $ (0.28) $ (0.22)
Weighted average shares outstanding used in computing per share amounts: 96,176,057 93,970,598
Diluted Net loss per share attributable to shareholders $ (0.28) $ (0.22)
Weighted average shares outstanding used in computing per share amounts: 96,176,057 93,970,598
v3.24.1.u1
Condensed Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Statement of Cash Flows [Abstract]    
Net loss for the period $ (27,345) $ (20,561)
Cash flows used in operating activities:    
Depreciation, amortization and accrued contingencies 53 (228)
Retirement pension obligations (8) (35)
Expenses related to share-based payments 1,958 1,632
Other elements 0 0
Changes in operating assets and liabilities:    
Decrease (increase) in other current assets (835) (3,098)
(Decrease) increase in trade payables (4,805) 4,478
(Decrease) increase in other current and non-current liabilities (3,765) (2,989)
Change in operating lease liabilities and right of use assets 56 (42)
Net cash flow provided by (used in) operating activities (34,692) (20,841)
Cash flows provided by (used in) investing activities:    
Acquisitions of property, plant, and equipment (1,335) (111)
Proceeds from property, plant, and equipment dispositions 0 0
Acquisitions of non-current financial assets (858) 0
Proceeds from non-current financial assets dispositions 62 153
Net cash flows provided by (used in) investing activities (2,132) 42
Cash flows provided by (used in) financing activities:    
(Decrease) increase in conditional advances 0 0
Treasury shares (62) (14)
Net cash flows provided by (used in) financing activities (62) (14)
Effect of exchange rate changes on cash and cash equivalents (2,957) 3,909
Net increase (decrease) in cash and cash equivalents (39,842) (16,905)
Net Cash and cash equivalents at the beginning of the period 101,525 192,289
Net cash and cash equivalents at the end of the period $ 141,367 $ 209,194
v3.24.1.u1
Condensed Consolidated Statements of Changes in Shareholders' Equity - USD ($)
$ in Thousands
Total
Common Shares [Member]
Additional Paid-in Capital [Member]
Treasury Stock [Member]
Accumulated Deficit [Member]
Accumulated Other Comprehensive income (loss) [Member]
Accumulated Currency Translation Effect [Member]
Beginning balance at Dec. 31, 2022 $ 194,453 $ 10,720 $ 458,221 $ (1,109) $ (259,578) $ 781 $ (14,581)
Beginning balance (Shares) at Dec. 31, 2022   94,137,145          
Net (loss) (20,561)       (20,561)    
Other comprehensive income (loss) 3,584         (82) 3,666
Issuance of ordinary shares 0 $ 1 (1)        
Issuance of ordinary shares (Shares)   10,174          
Treasury shares (14)     (14)      
Share-based payments 1,632   1,632        
Ending balance at Mar. 31, 2023 179,094 $ 10,721 459,852 (1,123) (280,138) 698 (10,915)
Ending balance (Shares) at Mar. 31, 2023   94,147,319          
Beginning balance at Dec. 31, 2023 140,187 $ 10,972 377,468 (1,263) (238,862) 742 (8,871)
Beginning balance (Shares) at Dec. 31, 2023   96,431,770          
Net (loss) (27,345)       (27,345)    
Other comprehensive income (loss) (3,084)         (59) (3,026)
Issuance of ordinary shares 0 $ 3 (3)        
Issuance of ordinary shares (Shares)   2,599          
Treasury shares (62)     (62)      
Share-based payments 1,958   1,958        
Ending balance at Mar. 31, 2024 $ 111,654 $ 10,972 $ 379,426 $ (1,325) $ (266,207) $ 683 $ (11,897)
Ending balance (Shares) at Mar. 31, 2024   96,434,369          
v3.24.1.u1
Pay vs Performance Disclosure - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Pay vs Performance Disclosure    
Net Income (Loss) $ (27,345) $ (20,561)
v3.24.1.u1
Insider Trading Arrangements
 3 Months Ended
Mar. 31, 2024
Trading Arrangements, by Individual  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.1.u1
The Company
 3 Months Ended
Mar. 31, 2024
Accounting Policies [Abstract]  
The Company
Note 1: The Company
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies” or the “Company”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.
Basis of Presentation
The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.
The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form
10-K
filed with the SEC on March 7, 2024 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2023 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, 2023.
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, 2024, 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 wind-down activities resulting from the termination of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets—operating lease, (4) impairment of
right-of-use
assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, (7) estimate of contingencies
,
and (8) estimate of employee benefits obligations.
Going Concern
These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists.
Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin Peanut, in August 2020, the Company scaled down its other clinical programs and
pre-clinical
spend to focus on Viaskin Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin Peanut in the United States and European Union.
 
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 CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the
6-month
safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population.
Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/ Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol.
In December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch was completed at the end of February 2022 and has been prepared for FDA submission.
In May 2022, the Company established an
At-The-Market
(“ATM”) program allowing 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”). 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 Platform and for working capital and other general corporate purposes.
In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect. The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut- allergic children ages 4 to 7 years.
During the same month, the Company announced private placement financing (“PIPE”) amounting to $194 million.
In September 2022, after announcing the initiation of the VITESSE clinical trial, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study. Within the FDA’s communication, the modifications 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.
On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that the VITESSE phase 3 clinical study may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024.
The company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.
Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024 will be sufficient to fund our operations until December 31, 2024.
The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings prior to December 31, 2024. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of
non-dilutive
financings.
The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. The
COVID-19
pandemic and conflict in Ukraine caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.
These Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern.
Accounting Pronouncements recently adopted
There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements.
There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows.
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.
v3.24.1.u1
Significant Events and Transactions
 3 Months Ended
Mar. 31, 2024
Significant Events And Transactions of the Period Disclsure [Abstract]  
Significant Events and Transactions
Note 2: Significant Events and Transactions
Clinical programs
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. 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,
 the
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.
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. The Company completed CHAMP in the second quarter of 2021. 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 the 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 on 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 sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. The Company estimated that the FDA’s newly proposed sequential 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 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. 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.
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
4-7
years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional 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 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 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 the Company satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE phase 3 clinical study may proceed with the revised trial protocol.
On March 2, 2023, the Company 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 scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA.
On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by the third quarter of 2024.
On April 19, 2023, the Company outlined the regulatory pathway 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 required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.
On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 –
3-years
and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 –
7-years
and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. FDA agreed with a
6-month
study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. 
The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program.
Viaskin Peanut for children ages
4-11—
European Union Regulatory History and Current Status
On August 2, 2021, the Company announced it received from the European Medicines Agency (EMA) 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.
On December 20, 2021, the Company announced it withdrew the Marketing Authorization Application (MAA) for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by 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 clinical 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 clinical 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
In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study, subjects 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 µg dose in this age group, which is the dose being studied in Part B of the EPITOPE phase 3 clinical study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021.
 
In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms respectively. Enrollment was balance for age and baseline disease characteristics between the active and placebo treatment arms.
The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages
1
to
3
years, given the high unmet need and absence of approved treatments for this vulnerable population.
On April 19, 2023, the Company outlined the regulatory pathway 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
1-3
years old with a confirmed peanut allergy.
In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.
The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program.
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
4-7
years with peanut allergy.
The Company
defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.
On September 21, 2022, the Company 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,
the Company
engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition,
the Company
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 the last patient is anticipated by
the third quarter of
2024.
In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. In summary, there was an agreement with the Agency that COMFORT Children will be a Double-Blind, Placebo-Controlled study involving approximately 270 children, randomized at a 3:1 ratio (active to placebo). Participation will not necessitate a food challenge, and patch adhesion data will be generated using the same approach as previously agreed upon with the FDA for the VITESSE phase 3 study.
Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children. This feedback included language simplification for how Viaskin should be used. Furthermore, the key inclusion criteria for the COMFORT Children study will be based on a physician-diagnosed peanut allergy, peanut-specific IgE and a Skin Prick Test (with no requirement for a DBPCFC). The revised protocol design of the safety study was submitted to the FDA in Q4 2023. COMFORT Children is anticipated to be initiated towards the end of VITESSE enrollment. The Company intends that enrollment of the COMFORT Children safety study will be strategically timed to avoid competition with the VITESSE study for the same subjects.
Legal Proceedings
From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings.
v3.24.1.u1
Cash and Cash Equivalents
 3 Months Ended
Mar. 31, 2024
Cash and Cash Equivalents [Abstract]  
Cash and Cash Equivalents
Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of March 31, 2024 and December 31, 2023:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Cash
      15,725        10,530  
Cash equivalents
      85,800        130,836  
  
 
 
     
 
 
  
Total cash and cash equivalents as reported in the statements of financial position
   
 
101,525
 
   
 
141,367
 
  
 
 
     
 
 
  
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Bank overdrafts
      —         —   
  
 
 
     
 
 
  
Total cash and cash equivalents as reported in the
statements
of cash flows
   
 
101,525
 
   
 
141,367
 
Cash equivalents are immediately convertible into cash at no or insignificant cost,
on
demand. They are measured using level 1 fair value measurements.
v3.24.1.u1
Other Current Assets
 3 Months Ended
Mar. 31, 2024
Other Current Assets [Abstract]  
Other Current Assets
Note 4
:
Other Current Assets
Other current assets consisted of the following:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Research tax credit
      10,066        8,857  
Other tax claims
      5,725        5,236  
Prepaid expenses
      1,727        2,103  
Other receivables
      518        1,353  
  
 
 
     
 
 
  
Total
   
 
18,037
 
   
 
17,548
 
  
 
 
     
 
 
  
Research tax credit
The variance in Research Tax Credit is presented as follows:
 
    
Amount in

thousands of US

Dollars
  
Opening research tax credit receivable as of January 1, 2024
   
 
8,857
 
+ Operating revenue
      1,407  
- Payment received
      —   
- Adjustment and currency translation effect
      (198 ) 
  
 
 
  
Closing research tax credit receivable as of March 31, 2024
   
 
10,066
 
  
 
 
  
Of which -
Non-current
portion
      —   
Of which - Current portion
   
 
10,066
 
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.
v3.24.1.u1
Lease contracts
 3 Months Ended
Mar. 31, 2024
Lessee Disclosure [Abstract]  
Lease contracts
Note 5
:
Lease contracts
Future minimum lease payments under the Company’s operating
leas
es’ right of use as of March 31, 2024 and December 31, 2023, are as follows:
 
    
March 31, 2024
    
December 31, 2023
  
    
Real estate
    
Other

assets
    
Total
    
Real estate
    
Other

assets
    
Total
  
Current portion
      344       61       405       1,205       71       1,275  
Year 2
      1,014       —        1,014       65       11       75  
Year 3
      1,259       —        1,259       421       —        421  
Thereafter
      6,256       —        6,256       5,515       —        5,515  
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Total minimum lease payments
   
 
8,873
 
  
 
61
 
  
 
8,934
 
  
 
7,205
 
  
 
81
 
  
 
7,295
 
Less: Effects of discounting
     (1,902 )      (7 )      (1,909 )      (1,617 )      (9 )      (1,626 ) 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Present value of operating lease
   
 
6,971
 
  
 
54
 
  
 
7,025
 
    
5
,588
    
 
73
 
  
 
5,670
 
Less: current portion
      (178 )      (54 )      (232 )      (1,072  
) 		     (72  
) 		     (1,144  
) 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Long-term operating lease
   
 
6,793
 
     —     
 
6,793
 
  
 
4,516
 
  
 
1
 
  
 
4,526
 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Weighted average remaining lease term (years)
      7.52       0.01       7.95       —     
Weighted average discount rate
      5.00 %      0.03  
% 		       4.53 %      2.50  
% 		  
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:
 
    
March 31,
  
  
2024
     
2023
  
Operating lease expense / (income)
      586        446  
Net termination impact
      (12 )       (81 ) 
Supplemental cash flow information related to operating leases is as follows for the period March 31, 2024 and 2023:
 
    
March 31
  
  
2024
     
2023
  
Cash paid for amounts included in the measurement of lease liabilities
      
Operating cash flows for operating leases
      501        496  
v3.24.1.u1
Trade payables and Other Liabilities
 3 Months Ended
Mar. 31, 2024
Payables and Accruals [Abstract]  
Trade payables and Other Liabilities
Note 6: Trade Payables and Other Liabilities
6.1 Trade Payables
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.
6.2 Other Current Liabilities
The following tables summarize the other current liabilities as of March 31, 2024 and December 31, 2023:
 
    
March 31
     
December 31,
  
    
2024
     
2023
  
    
Other
 current
liabilities
     
Other
 non-
current
liabilities
     
Total
     
Other
 current
liabilities
     
Other
 non-
current
liabilities
     
Total
  
Employee related liabilities
      4,629        —         4,629        7,828        —         7,828  
Tax liabilities
      180        —         180        223        —         223  
Other debts
      214        —         214        883        —         883  
  
 
 
     
 
 
     
 
 
     
 
 
     
 
 
     
 
 
  
Total
   
 
5,023
 
      —      
 
5,023
 
   
 
8,934
 
      —      
 
8,934
 
  
 
 
     
 
 
     
 
 
     
 
 
     
 
 
     
 
 
  
 
The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations as of March 31, 2024. The Employee related liabilities included short-term debt to employees including social welfare, tax agency obligations and bonus provision (paid during first quarter 2024)
as
of December 31, 2023.
v3.24.1.u1
Shareholders' equity
 3 Months Ended
Mar. 31, 2024
Stockholders' Equity Note [Abstract]  
Shareholders' equity
Note 7: Shareholders’ equity
The share capital as of March 31, 2024 is set at the sum of €9,643,437 ($10,972 thousands converted at historical rates). It is divided into 96,434,369 fully authorized, subscribed and
paid-up
ordinary
shares with a par value of €0.10.
v3.24.1.u1
Share-Based Payments
 3 Months Ended
Mar. 31, 2024
Share-based Payment Arrangement [Abstract]  
Share-Based Payments
Note 8: Share-Based Payments
The Board of Directors has been authorized by the Shareholders General Meeting to grant restricted stock units (“RSU”), stock options (“SO”) and
non-employee
warrants (
Bons de Souscription d’Actions
or “BSA”).
During the three months ended March 31, 2024, the Company granted 262,000 stock options and 59,000 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, 2023
   
 
244,693
 
   
 
7,129,541
 
   
 
2,021,370
 
Granted during the period
      —         262,000        59,000  
Forfeited during the period
      —         3,525        13,738  
Exercised/released duri
n
g the period
      —         —         2,598  
Expired during the period
      —         —         —   
  
 
 
     
 
 
     
 
 
  
Balance as of March 31, 2024
   
 
244,693
 
   
 
7,388,016
 
   
 
2,064,035
 
  
 
 
     
 
 
     
 
 
  
Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research & development
      SO        (513 )       (429 ) 
  
 
RSU
 
   
 
(256
) 
   
 
(258
) 
Sales & marketing
      SO        (23 )       (27 ) 
  
 
RSU
 
   
 
(9
) 
   
 
(8
) 
General & administrative
      SO        (1,030 )       (797 ) 
  
 
RSU
 
   
 
(126
) 
   
 
(113
) 
     
 
 
     
 
 
  
Total share-based compensation (expense)
      
 
(1,958
) 
   
 
(1,632
) 
     
 
 
     
 
 
  
The $0.3 million increase in share-based compensation expenses is notably due to the increase of number of ordinary share equivalents granted in 2023 impacting the three months ended March 31, 2024, in comparison to the number granted in 2022 impacting the three months ended March 31, 2023.
v3.24.1.u1
Contingencies
 3 Months Ended
Mar. 31, 2024
Loss Contingency [Abstract]  
Contingencies
Note 9: Contingencies
The following tables summarize the contingencies as of March 31, 2024 and December 31, 2023:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Current contingencies
      3,153        3,959  
Non-current
contingencies
      965        935  
  
 
 
     
 
 
  
Total contingencies
   
 
4,118
 
   
 
4,894
 
  
 
 
     
 
 
  
The changes in contingencies are as follows:
 
    
Pension

retirement

obligations
     
Other

contingencies
     
Total
  
At January 1, 2024
   
 
935
 
   
 
3,959
 
   
 
4,894
 
Increases in liabilities
      —         —         —   
Used liabilities
      —         (723 )       (723 ) 
Reversals of unused liabilities
      (8 )       —         (8 ) 
Net interest related to employee benefits, and unwinding of discount
      —         —         —   
Actuarial gains and losses on defined-benefit plans
      59        —         59  
Currency translation effect
      (20 )       (82 )       (103 ) 
  
 
 
     
 
 
     
 
 
  
At March 31, 2024
   
 
965
 
   
 
3,153
 
   
 
4,118
 
  
 
 
     
 
 
     
 
 
  
 
    
Pension

retirement

obligations
     
Other

contingencies
     
Total
  
Of which Current
   
 
— 
 
   
 
3,153
 
   
 
3,153
 
Of which
Non-current
   
 
965
 
   
 
— 
 
   
 
965
 
In May 2016, the Company entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”) under which the Company was responsible for leading the development activities of MAG1C up through a pivotal phase 3 clinical program.
On October 30, 2023, the Company signed and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement.
As of March 31, 2024, the accrual for ongoing Clinical study completion totals $1.3 million (vs. $2.3 million as of December 31, 2023) representing our best estimate of the remaining expenses related to the ongoing clinical study.
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 14 to the consolidated financial statements included in the Annual Report.
v3.24.1.u1
Operating Income
 3 Months Ended
Mar. 31, 2024
Other Income and Expenses [Abstract]  
Operating Income
Note 10: Operating income
The following table summarizes the operating income during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research tax credit
      1,407        1,765  
Other operating income
      —         429  
  
 
 
     
 
 
  
Total
   
 
1,407
 
   
 
2,194
 
  
 
 
     
 
 
  
As of March 31, 2023, other income were recorded according the Collaboration Agreement between the Company and NESTEC.
On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement, explaining the lack of other income as of March 31, 2024.
v3.24.1.u1
Operating Expenses
 3 Months Ended
Mar. 31, 2024
Operating Expenses [Abstract]  
Operating expenses
Note 11: Operating expenses
The Company had an average of 105 employees during the three months ended March 31, 2024, in comparison with an average of 87 employees during the three months ended March 31, 2023. This increase is mainly due to hiring to support clinical development activities related to ongoing and anticipated clinical trials and to support quality activities.
The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research and Development expenses
      5,048        4,006  
Sales and Marketing expenses
      334        165  
General and Administrative expenses
      3,236        3,100  
  
 
 
     
 
 
  
Total personnel expenses
   
 
8,618
 
   
 
7,272
 
  
 
 
     
 
 
  
 
The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Wages and salaries
      5,144        4,438  
Social security contributions
      1,207        699  
Expenses for pension commitments
      309        258  
Employer contribution to bonus shares
      —         244  
Share-based payments
      1,958        1,632  
  
 
 
     
 
 
  
Total
   
 
8,618
 
   
 
7,272
 
  
 
 
     
 
 
  
The increase in personnel expenses is mainly due to the recruitment of US employees.
v3.24.1.u1
Financial Income (Expense)
 3 Months Ended
Mar. 31, 2024
Financial Income Expense [Abstract]  
Financial income (expense)
Note 12: Financial income (expense)
Our financial income was $1.3 million for the three months ended March 31, 2024, compared to $0.6 million for the three
months
ended March 31, 2023. This item mainly includes the financial income on our financial assets.
v3.24.1.u1
Commitments
 3 Months Ended
Mar. 31, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments
Note 13: Commitments
There has been no significant change in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.
v3.24.1.u1
Relationships with Related Parties
 3 Months Ended
Mar. 31, 2024
Related Party Transactions [Abstract]  
Relationships with Related Parties
Note 14: Relationships with Related Parties
There were no new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.
v3.24.1.u1
Loss Per Share
 3 Months Ended
Mar. 31, 2024
Earnings Per Share [Abstract]  
Loss Per Share
Note 15: Loss Per Share
Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three months ended March 31, 2024 and 2023, 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 months ended March 31, 2024 and 2023 indicated in number of potential shares:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Non-employee
warrants
      244,693        251,693  
Stock options
      7,388,016        5,318,569  
Restricted stock units
      2,064,035        1,583,938  
Prefunded warrants
      28,276,331        28,276,331
v3.24.1.u1
Events After the Close of the Period
 3 Months Ended
Mar. 31, 2024
Subsequent Events [Abstract]  
Events after the Close of the Period
Note 16: Events after the Close of the Period
The Company evaluated subsequent events that occurred after March 31, 2024, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on May 7, 2024 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
On April 22, 2024, the Company moved its headquarters to 107 Avenue de la République in Châtillon in France, which is subject to ratification by the shareholders of the Company at the annual general meeting on May 16, 2024.
v3.24.1.u1
The Company (Policies)
 3 Months Ended
Mar. 31, 2024
Accounting Policies [Abstract]  
Basis of Presentation
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 7, 2024 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2023 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, 2023.
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, 2024, or any other future period.
Use of estimates
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 wind-down activities resulting from the termination of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets—operating lease, (4) impairment of
right-of-use
assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, (7) estimate of contingencies
,
and (8) estimate of employee benefits obligations.
Going concern
Going Concern
These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists.
Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin Peanut, in August 2020, the Company scaled down its other clinical programs and
pre-clinical
spend to focus on Viaskin Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin Peanut in the United States and European Union.
 
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 CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the
6-month
safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population.
Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/ Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol.
In December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch was completed at the end of February 2022 and has been prepared for FDA submission.
In May 2022, the Company established an
At-The-Market
(“ATM”) program allowing 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”). 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 Platform and for working capital and other general corporate purposes.
In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect. The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut- allergic children ages 4 to 7 years.
During the same month, the Company announced private placement financing (“PIPE”) amounting to $194 million.
In September 2022, after announcing the initiation of the VITESSE clinical trial, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study. Within the FDA’s communication, the modifications 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.
On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that the VITESSE phase 3 clinical study may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024.
The company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.
Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024 will be sufficient to fund our operations until December 31, 2024.
The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings prior to December 31, 2024. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of
non-dilutive
financings.
The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. The
COVID-19
pandemic and conflict in Ukraine caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.
These Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern.
Accounting Pronouncements recently adopted
Accounting Pronouncements recently adopted
There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements.
There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows.
Accounting Pronouncements issued not yet adopted
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.
v3.24.1.u1
Cash and Cash Equivalents (Tables)
 3 Months Ended
Mar. 31, 2024
Cash and Cash Equivalents [Abstract]  
Summary of breakdown of cash and cash equivalents
The following tables summarize the cash and cash equivalents as of March 31, 2024 and December 31, 2023:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Cash
      15,725        10,530  
Cash equivalents
      85,800        130,836  
  
 
 
     
 
 
  
Total cash and cash equivalents as reported in the statements of financial position
   
 
101,525
 
   
 
141,367
 
  
 
 
     
 
 
  
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Bank overdrafts
      —         —   
  
 
 
     
 
 
  
Total cash and cash equivalents as reported in the
statements
of cash flows
   
 
101,525
 
   
 
141,367
 
v3.24.1.u1
Other Current Assets (Tables)
 3 Months Ended
Mar. 31, 2024
Other Current Assets [Abstract]  
Summary of Other Current Asset
Other current assets consisted of the following:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Research tax credit
      10,066        8,857  
Other tax claims
      5,725        5,236  
Prepaid expenses
      1,727        2,103  
Other receivables
      518        1,353  
  
 
 
     
 
 
  
Total
   
 
18,037
 
   
 
17,548
 
  
 
 
     
 
 
  
Summary of Research Tax Credit
The variance in Research Tax Credit is presented as follows:
 
    
Amount in

thousands of US

Dollars
  
Opening research tax credit receivable as of January 1, 2024
   
 
8,857
 
+ Operating revenue
      1,407  
- Payment received
      —   
- Adjustment and currency translation effect
      (198 ) 
  
 
 
  
Closing research tax credit receivable as of March 31, 2024
   
 
10,066
 
  
 
 
  
Of which -
Non-current
portion
      —   
Of which - Current portion
   
 
10,066
 
v3.24.1.u1
Lease contracts (Tables)
 3 Months Ended
Mar. 31, 2024
Lessee Disclosure [Abstract]  
Summary of Operating Leases Future Minimum Payments Receivable
Future minimum lease payments under the Company’s operating
leas
es’ right of use as of March 31, 2024 and December 31, 2023, are as follows:
 
    
March 31, 2024
    
December 31, 2023
  
    
Real estate
    
Other

assets
    
Total
    
Real estate
    
Other

assets
    
Total
  
Current portion
      344       61       405       1,205       71       1,275  
Year 2
      1,014       —        1,014       65       11       75  
Year 3
      1,259       —        1,259       421       —        421  
Thereafter
      6,256       —        6,256       5,515       —        5,515  
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Total minimum lease payments
   
 
8,873
 
  
 
61
 
  
 
8,934
 
  
 
7,205
 
  
 
81
 
  
 
7,295
 
Less: Effects of discounting
     (1,902 )      (7 )      (1,909 )      (1,617 )      (9 )      (1,626 ) 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Present value of operating lease
   
 
6,971
 
  
 
54
 
  
 
7,025
 
    
5
,588
    
 
73
 
  
 
5,670
 
Less: current portion
      (178 )      (54 )      (232 )      (1,072  
) 		     (72  
) 		     (1,144  
) 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Long-term operating lease
   
 
6,793
 
     —     
 
6,793
 
  
 
4,516
 
  
 
1
 
  
 
4,526
 
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
  
Weighted average remaining lease term (years)
      7.52       0.01       7.95       —     
Weighted average discount rate
      5.00 %      0.03  
% 		       4.53 %      2.50  
% 		  
Summary of Rent expenses Rent expense presented in the condensed consolidated statement of operations and comprehensive loss was:
 
    
March 31,
  
  
2024
     
2023
  
Operating lease expense / (income)
      586        446  
Net termination impact
      (12 )       (81 ) 
Summary of Supplemental cash flow information related to our operating leases
Supplemental cash flow information related to operating leases is as follows for the period March 31, 2024 and 2023:
 
    
March 31
  
  
2024
     
2023
  
Cash paid for amounts included in the measurement of lease liabilities
      
Operating cash flows for operating leases
      501        496  
v3.24.1.u1
Trade payables and Other Liabilities (Tables)
 3 Months Ended
Mar. 31, 2024
Other Liabilities, Current [Abstract]  
Summary of Other Current Liabilities
The following tables summarize the other current liabilities as of March 31, 2024 and December 31, 2023:
 
    
March 31
     
December 31,
  
    
2024
     
2023
  
    
Other
 current
liabilities
     
Other
 non-
current
liabilities
     
Total
     
Other
 current
liabilities
     
Other
 non-
current
liabilities
     
Total
  
Employee related liabilities
      4,629        —         4,629        7,828        —         7,828  
Tax liabilities
      180        —         180        223        —         223  
Other debts
      214        —         214        883        —         883  
  
 
 
     
 
 
     
 
 
     
 
 
     
 
 
     
 
 
  
Total
   
 
5,023
 
      —      
 
5,023
 
   
 
8,934
 
      —      
 
8,934
 
  
 
 
     
 
 
     
 
 
     
 
 
     
 
 
     
 
 
  
v3.24.1.u1
Share-Based Payments (Tables)
 3 Months Ended
Mar. 31, 2024
Summary of RSU Activity
Change in Number of BSA/SO/RSU:
 
    
Number of outstanding
  
    
BSA
     
SO
     
RSUs
  
Balance as of December 31, 2023
   
 
244,693
 
   
 
7,129,541
 
   
 
2,021,370
 
Granted during the period
      —         262,000        59,000  
Forfeited during the period
      —         3,525        13,738  
Exercised/released duri
n
g the period
      —         —         2,598  
Expired during the period
      —         —         —   
  
 
 
     
 
 
     
 
 
  
Balance as of March 31, 2024
   
 
244,693
 
   
 
7,388,016
 
   
 
2,064,035
 
  
 
 
     
 
 
     
 
 
  
Summary of Share-Based Payments Expenses
Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research & development
      SO        (513 )       (429 ) 
  
 
RSU
 
   
 
(256
) 
   
 
(258
) 
Sales & marketing
      SO        (23 )       (27 ) 
  
 
RSU
 
   
 
(9
) 
   
 
(8
) 
General & administrative
      SO        (1,030 )       (797 ) 
  
 
RSU
 
   
 
(126
) 
   
 
(113
) 
     
 
 
     
 
 
  
Total share-based compensation (expense)
      
 
(1,958
) 
   
 
(1,632
) 
     
 
 
     
 
 
  
v3.24.1.u1
Contingencies (Tables)
 3 Months Ended
Mar. 31, 2024
Loss Contingency [Abstract]  
Summary of Non-current Contingencies and Current Contingencies
The following tables summarize the contingencies as of March 31, 2024 and December 31, 2023:
 
    
March 31,
     
December 31,
  
    
2024
     
2023
  
Current contingencies
      3,153        3,959  
Non-current
contingencies
      965        935  
  
 
 
     
 
 
  
Total contingencies
   
 
4,118
 
   
 
4,894
 
  
 
 
     
 
 
  
Summary of Movement in Provisions
The changes in contingencies are as follows:
 
    
Pension

retirement

obligations
     
Other

contingencies
     
Total
  
At January 1, 2024
   
 
935
 
   
 
3,959
 
   
 
4,894
 
Increases in liabilities
      —         —         —   
Used liabilities
      —         (723 )       (723 ) 
Reversals of unused liabilities
      (8 )       —         (8 ) 
Net interest related to employee benefits, and unwinding of discount
      —         —         —   
Actuarial gains and losses on defined-benefit plans
      59        —         59  
Currency translation effect
      (20 )       (82 )       (103 ) 
  
 
 
     
 
 
     
 
 
  
At March 31, 2024
   
 
965
 
   
 
3,153
 
   
 
4,118
 
  
 
 
     
 
 
     
 
 
  
 
    
Pension

retirement

obligations
     
Other

contingencies
     
Total
  
Of which Current
   
 
— 
 
   
 
3,153
 
   
 
3,153
 
Of which
Non-current
   
 
965
 
   
 
— 
 
   
 
965
 
v3.24.1.u1
Operating Income (Tables)
 3 Months Ended
Mar. 31, 2024
Other Income and Expenses [Abstract]  
Schedule of operating income
The following table summarizes the operating income during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research tax credit
      1,407        1,765  
Other operating income
      —         429  
  
 
 
     
 
 
  
Total
   
 
1,407
 
   
 
2,194
 
  
 
 
     
 
 
  
v3.24.1.u1
Operating Expenses (Tables)
 3 Months Ended
Mar. 31, 2024
Operating Expenses [Abstract]  
Summary of Allocation of Personnel Expenses By Function
The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Research and Development expenses
      5,048        4,006  
Sales and Marketing expenses
      334        165  
General and Administrative expenses
      3,236        3,100  
  
 
 
     
 
 
  
Total personnel expenses
   
 
8,618
 
   
 
7,272
 
  
 
 
     
 
 
  
Summary of Allocation of Personnel Expenses By Nature
The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2024 and 2023:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Wages and salaries
      5,144        4,438  
Social security contributions
      1,207        699  
Expenses for pension commitments
      309        258  
Employer contribution to bonus shares
      —         244  
Share-based payments
      1,958        1,632  
  
 
 
     
 
 
  
Total
   
 
8,618
 
   
 
7,272
 
  
 
 
     
 
 
  
v3.24.1.u1
Loss Per Share (Tables)
 3 Months Ended
Mar. 31, 2024
Earnings Per Share, Basic [Abstract]  
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
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 months ended March 31, 2024 and 2023 indicated in number of potential shares:
 
    
Three Months Ended

March 31,
  
    
2024
     
2023
  
Non-employee
warrants
      244,693        251,693  
Stock options
      7,388,016        5,318,569  
Restricted stock units
      2,064,035        1,583,938  
Prefunded warrants
      28,276,331        28,276,331
v3.24.1.u1
The Company - Additional Information (Detail) - USD ($)
$ in Thousands
 1 Months Ended 6 Months Ended
May 31, 2022
Jun. 30, 2022
Mar. 31, 2024
Dec. 31, 2023
Subsidiary or Equity Method Investee [Line Items]        
Cash and cash equivalents     $ 101,525 $ 141,367
American Depositary Shares [Member] | At The Market [Member]        
Subsidiary or Equity Method Investee [Line Items]        
Proceeds From Issuance Of Common Stock $ 100,000      
Private Investment In Public Equity [Member]        
Subsidiary or Equity Method Investee [Line Items]        
Proceeds From Issuance Of Common Stock   $ 194,000    
v3.24.1.u1
Significant Events and Transactions - Additional Information (Detail) - ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member] - Candidates
Jul. 31, 2023
Jan. 31, 2020
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Clinical Program Trial Period   6 months
Comfort Toddlers Safety Study [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Total number of additional candidates covered by the study 400  
Period for which the study shall be carried out 6 months  
Comfort Children Safety Study [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Period for which the study shall be carried out 6 months  
Minimum [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Age Of Child   4 years
Minimum [Member] | Comfort Toddlers Safety Study [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Age Of Child 1 year  
Minimum [Member] | Comfort Children Safety Study [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Age Of Child 4 years  
Maximum [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Age Of Child   11 years
Maximum [Member] | Comfort Toddlers Safety Study [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Age Of Child 3 years  
Maximum [Member] | Comfort Children Safety Study [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Age Of Child 7 years  
v3.24.1.u1
Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Cash and Cash Equivalents, at Carrying Value [Abstract]    
Cash $ 15,725 $ 10,530
Cash equivalents 85,800 130,836
Total cash and cash equivalents as reported in the statements of financial position 101,525 141,367
Bank overdrafts 0 0
Total cash and cash equivalents as reported in the statements of cash flows $ 101,525 $ 141,367
v3.24.1.u1
Other Current Assets - Summary of Other Current Asset (Detail) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Other Assets [Abstract]    
Research tax credit $ 10,066 $ 8,857
Other tax claims 5,725 5,236
Prepaid expenses 1,727 2,103
Other receivables 518 1,353
Total $ 18,037 $ 17,548
v3.24.1.u1
Other Current Assets - Summary Of Research Tax Credit (Detail)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
USD ($)
Tax Credit Carryforward [Line Items]  
Opening balance $ 8,857
+ Operating revenue 1,407
- Payment received 0
- Adjustment and currency translation effect (198)
Closing balance 10,066
Of which - Non-current portion 0
Of which - Current portion $ 10,066
v3.24.1.u1
Lease contracts - Summary of Operating Leases Future Minimum Payments Receivable (Detail) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Current portion $ 405 $ 1,275
Year 2 1,014 75
Year 3 1,259 421
Thereafter 6,256 5,515
Total minimum lease payments 8,934 7,295
Less: Effects of discounting (1,909) (1,626)
Present value of operating lease 7,025 5,670
Less: current portion (232) (1,144)
Long-term operating lease 6,793 4,526
Real Estate [Member]    
Current portion 344 1,205
Year 2 1,014 65
Year 3 1,259 421
Thereafter 6,256 5,515
Total minimum lease payments 8,873 7,205
Less: Effects of discounting (1,902) (1,617)
Present value of operating lease 6,971 5,588
Less: current portion (178) (1,072)
Long-term operating lease $ 6,793 $ 4,516
Weighted average remaining lease term (years) 7 years 6 months 7 days 7 years 11 months 12 days
Weighted average discount rate 5.00% 4.53%
Other Asset [Member]    
Current portion $ 61 $ 71
Year 2 0 11
Year 3 0 0
Thereafter 0 0
Total minimum lease payments 61 81
Less: Effects of discounting (7) (9)
Present value of operating lease 54 73
Less: current portion (54) (72)
Long-term operating lease $ 0 $ 1
Weighted average remaining lease term (years) 3 days  
Weighted average discount rate 0.03% 2.50%
v3.24.1.u1
Lease contracts - Summary of Rent expenses (Detail) - Rent Expenses [Member] - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Operating lease expense / (income) $ 586 $ 446
Net termination impact $ (12) $ (81)
v3.24.1.u1
Lease contracts - Summary of Supplemental cash flow information related to our operating leases (Detail) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Cash Flow, Operating Activities, Lessee [Abstract]    
Operating cash flows from operating leases $ 501 $ 496
v3.24.1.u1
Trade payables and Other Liabilities - Summary of Other Current Liabilities (Detail) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Other current liabilities $ 5,023 $ 8,934
Other non-current liabilities 0 0
Total 5,023 8,934
Employee Related Liabilities [Member]    
Other current liabilities 4,629 7,828
Other non-current liabilities 0 0
Total 4,629 7,828
Tax Liabilities [Member]    
Other current liabilities 180 223
Other non-current liabilities 0 0
Total 180 223
Other Debts [Member]    
Other current liabilities 214 883
Other non-current liabilities 0 0
Total $ 214 $ 883
v3.24.1.u1
Shareholders' equity - Additional Information (Detail)
€ / shares in Units, € in Thousands, $ in Thousands
Mar. 31, 2024
USD ($)
shares
Mar. 31, 2024
EUR (€)
€ / shares
shares
Dec. 31, 2023
USD ($)
Mar. 31, 2023
USD ($)
Dec. 31, 2022
USD ($)
Class of Stock [Line Items]          
Share capital | $ $ 111,654   $ 140,187 $ 179,094 $ 194,453
Share capital [Member]          
Class of Stock [Line Items]          
Share capital authorized | shares 96,434,369 96,434,369      
Nominal value | € / shares   € 0.1      
Share capital $ 10,972 € 9,643,437      
v3.24.1.u1
Share-Based Payments - Summary of RSU Activity (Detail)
 3 Months Ended
Mar. 31, 2024
shares
BSA Warrants [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of warrants outstanding, Beginning Balance 244,693
Number of warrants outstanding, Ending Balance 244,693
Restricted Stock Units [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of RSU outstanding, Beginning Balance 2,021,370
Number of RSU outstanding, Granted during the period 59,000
Number of RSU outstanding, Forfeited during the period 13,738
Number of RSU outstanding, Released during the period 2,598
Number of RSU outstanding, Ending Balance 2,064,035
Share-based Payment Arrangement, Option [Member]  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Number of stock options outstanding, Beginning Balance 7,129,541
Number of stock options outstanding, Granted during the period 262,000
Number of stock options outstanding, Forfeited during the period 3,525
Number of stock options outstanding, Ending Balance 7,388,016
v3.24.1.u1
Share-Based Payments - Summary of Share-Based Payments Expenses (Detail) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments $ (1,958) $ (1,632)
Research and Development expenses [Member] | Share options [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (513) (429)
Research and Development expenses [Member] | Restricted Stock Units [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (256) (258)
Sales and Marketing expenses [Member] | Share options [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (23) (27)
Sales and Marketing expenses [Member] | Restricted Stock Units [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (9) (8)
General and Administrative expenses [Member] | Share options [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments (1,030) (797)
General and Administrative expenses [Member] | Restricted Stock Units [Member]    
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]    
Share-based payments $ (126) $ (113)
v3.24.1.u1
Share-Based Payments - Additional Information (Detail)
$ in Millions
 3 Months Ended
Mar. 31, 2024
USD ($)
shares
Share-Based Payments [Line iteam]  
Increase in sharebased compensation expense | $ $ 0.3
Share options [Member]  
Share-Based Payments [Line iteam]  
Number of stock options outstanding, Granted during the period 262,000
Restricted Stock Units [Member]  
Share-Based Payments [Line iteam]  
Number of RSU outstanding, Granted during the period 59,000
v3.24.1.u1
Contingencies - Summary of Non Current Contingencies and Current Contingencies (Detail) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Liability, Defined Benefit Plan [Abstract]    
Current contingencies $ 3,153 $ 3,959
Non-current contingencies 965 935
Total contingencies $ 4,118 $ 4,894
v3.24.1.u1
Contingencies - Summary of Movement in Contingencies (Detail) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Dec. 31, 2023
Of which Current $ 3,153 $ 3,959
Of which Non-current 965 $ 935
Pension retirement obligations [Member]    
Contingencies, Beginning balance 935  
Increases in liabilities 0  
Reversals of unused liabilities (8)  
Actuarial gains and losses on defined-benefit plans 59  
Currency translation effect (20)  
Contingencies, Ending balance 965  
Of which Non-current 965  
Collaboration agreement -Loss at completion [Member]    
Contingencies, Beginning balance 3,959  
Increases in liabilities 0  
Used liabilities (723)  
Reversals of unused liabilities 0  
Currency translation effect (82)  
Contingencies, Ending balance 3,153  
Of which Current 3,153  
Of which Non-current 0  
Other provisions incl. restructuring [Member]    
Contingencies, Beginning balance 4,894  
Increases in liabilities 0  
Used liabilities (723)  
Reversals of unused liabilities (8)  
Net interest related to employee benefits, and unwinding of discount 0  
Actuarial gains and losses on defined-benefit plans 59  
Currency translation effect (103)  
Contingencies, Ending balance 4,118  
Of which Current 3,153  
Of which Non-current $ 965  
v3.24.1.u1
Contingencies - Additional Information (Detail) - USD ($)
$ in Millions
Mar. 31, 2024
Dec. 31, 2023
Loss Contingency [Abstract]    
Accrued Contract Expenses $ 1.3 $ 2.3
v3.24.1.u1
Operating Income - Summary of Operating Income (Detail) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Other Income and Expenses [Abstract]    
Research tax credit $ 1,407 $ 1,765
Other operating income 0 429
Total $ 1,407 $ 2,194
v3.24.1.u1
Operating Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Research and Development expenses $ 21,403 $ 16,037
Sales and Marketing expenses 758 434
General and Administrative expenses 7,804 6,889
Total Operating expenses 29,964 23,359
Expenses by Function [Member]    
Research and Development expenses 5,048 4,006
Sales and Marketing expenses 334 165
General and Administrative expenses 3,236 3,100
Total Operating expenses $ 8,618 $ 7,272
v3.24.1.u1
Operating Expenses - Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Share-based payments $ (1,958) $ (1,632)
Total Operating expenses 29,964 23,359
Expenses by Nature [Member]    
Wages and salaries 5,144 4,438
Social security contributions 1,207 699
Expenses for pension commitments 309 258
Employer contribution to bonus shares 0 244
Share-based payments 1,958 1,632
Total Operating expenses $ 8,618 $ 7,272
v3.24.1.u1
Financial Income (Expense) - Additional Information (Detail) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Financial Income Expense [Abstract]    
Financial income (expenses) $ 1,261 $ 605
v3.24.1.u1
Commitments - Additional Information (Detail)
 3 Months Ended
Mar. 31, 2024
USD ($)
Disclosure Of Commitments [Line Items]  
Increase (decrease) in other commitments during the period $ 0
v3.24.1.u1
Relationships with Related Parties - Additional Information (Detail)
$ in Thousands
 3 Months Ended
Mar. 31, 2024
USD ($)
Related Party Transactions [Abstract]  
Increase decrease in related party transactions and changes in nature of the transactions $ 0
v3.24.1.u1
Loss Per Share - Summary of the Common Stock Equivalents Which Were Excluded From the Calculation of Diluted Net Loss Per Share (Detail) - shares
 3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Non-employee warrants [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 244,693 251,693
Stock options [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 7,388,016 5,318,569
Restricted stock units [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 2,064,035 1,583,938
Prefunded warrants [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount 28,276,331 28,276,331
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