DBVT 10-Q Quarterly Report Sept. 30, 2023 | Alphaminr
DBV Technologies S.A.
ALPHAMINR

DBVT 10-Q Quarter ended Sept. 30, 2023

Balance Sheet
Cash Flow
Income Statement
10-Q
Table of Contents
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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 September 30, 2023
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
State or other jurisdiction of
incorporation or organization
Not applicable
(I.R.S. Employer
Identification No.)
177-181
avenue Pierre Brossolette
N/A
92120 Montrouge France (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
DBVT
The Nasdaq Stock Market LLC
one-half
of one ordinary share, nominal value
€0.10 per share
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 October 31, 2023, the registrant had 96,288,553 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.

Table of Contents

Table of contents

Part I Financial information 5
Item 1 Condensed Consolidated Statements of Financial Position (Unaudited) as of September 30, 2023 and December 31, 2022 5
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Nine Months Ended September 30,2023 and 2022 6
Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2023 and 2022 7
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Nine Months Ended September 30, 2023 and 2022 8
Notes to the Condensed Consolidated Financial Statements (Unaudited) 9
Item 2 Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
Item 3 Quantitative and Qualitative Disclosures About Market Risk 26
Item 4 Controls and Procedures 26
Part II Other Information 26
Item 1 Legal Proceedings 26
Item 1A Risk Factors 27
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds 27
Item 3 Defaults Upon Senior Securities 27
Item 4 Mine Safety Disclosures 27
Item 5 Other Information 27
Item 6 Exhibits 27

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.

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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 ViaskinTM Peanut to the U.S. Food and Drug Administration, or the FDA;
•
the 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 grant 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, 2022, filed with the Securities and Exchange Commission, or the SEC on March 2, 2023. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements.
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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.
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Table of Contents
Part I – Financial Information
Item 1. Financial Statements
DBV Technologies S.A.
Condensed Consolidated Statements of Financial Position (unaudited)
(amounts in thousands, except share and per share data)

September 30,
December 31,
Notes
2023
2022
Assets
Current assets:
Cash and cash equivalents
3 $ 149,135 $ 209,194
Other current assets
4 20,136 13,880
Total current assets
169,270 223,074
Property, plant, and equipment, net
13,094 15,096
Right-of-use
assets related to operating leases
5 1,389 2,513
Intangible assets
61 10
Other
non-current
assets
5,970 5,824
Total
non-current
assets
20,513 23,444
Total Assets
$ 189,783 $ 246,518
Liabilities and shareholders’ equity
Current liabilities:
Trade payables
6 $ 16,654 $ 14,473
Short-term operating leases
5 1,522 1,894
Current contingencies
9 4,596 3,944
Other current liabilities
6 8,671 9,210
Total current liabilities
31,443 29,521
Long-term operating leases
5 94 1,127
Non-current
contingencies
9 11,553 16,680
Other
non-current
liabilities
6 2,702 4,735
Total
non-current
liabilities
14,349 22,543
Total Liabilities
$ 45,792 $ 52,064
Shareholders’ equity:
Ordinary shares, € 0.10 par value; 96,253,553 and 94,137,145 shares authorized, and issued as of
September 30, 2023 and December 31, 2022, respectively
$ 10,953 $ 10,720
Additional
paid-in
capital
376,249 458,221
Treasury stock, 175,481 and 149,793 ordinary shares as of September 30, 2023 and December 31, 2022, respectively, at cost
( 1,163 ) ( 1,109 )
Accumulated deficit
( 227,677 ) ( 259,578 )
Accumulated other comprehensive income
761 781
Accumulated currency translation effect
( 15,132 ) ( 14,581 )
Total Shareholders’ equity
7 $ 143,991 $ 194,453
Total Liabilities and Shareholders’ equity
$ 189,783 $ 246,518
The accompanying notes are an integral part of these condensed consolidated financial statements.
5

DBV Technologies S.A.
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(amounts in thousands, except share and per share data)

Three Months Ended September 30,
Nine Months Ended
September 30,
Notes
2023
2022
2023
2022
Operating income
10 $ 2,372 $ 2,074 $ 6,853 $ 6,148
Operating expenses
Research and development expenses
( 13,795 ) ( 15,096 ) ( 47,448 ) ( 45,930 )
Sales and marketing expenses
( 663 ) ( 159 ) ( 1,613 ) ( 1,659 )
General and administrative expenses
( 6,184 ) ( 4,839 ) ( 22,304 ) ( 17,173 )
Total Operating expenses
( 20,642 ) ( 20,094 ) ( 71,365 ) ( 64,762 )
Loss from operations
( 18,270 ) ( 18,020 ) ( 64,512 ) ( 58,614 )
Financial income (expenses)
1,534 732 2,984 1,668
Loss before taxes
( 16,736 ) ( 17,287 ) ( 61,527 ) ( 56,946 )
Income tax
— — ( 13 ) ( 87 )
Net loss
$ ( 16,736 ) $ ( 17,287 ) $ ( 61,540 ) $ ( 57,033 )
Foreign currency translation differences, net of taxes
( 3,996 ) ( 15,425 ) ( 551 ) ( 28,752 )
Actuarial gains (losses) on employee benefits, net of taxes
73 41 ( 19 ) 264
Total comprehensive loss
$ ( 20,659 ) $ ( 32,672 ) $ ( 62,111 ) $ ( 85,520 )
Basic/diluted net loss per share attributable to shareholders
14 $ ( 0.17 ) $ ( 0.18 ) $ ( 0.65 ) $ ( 0.79 )
Weighted average shares outstanding used in computing per share amounts:
96,075,540 93,905,050 94,801,569 71,779,572
The accompanying notes are an integral part of these condensed consolidated financial statements.
6

DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)

Nine Months
Ended September 30,
Notes
2023
2022
Net loss for the period
$ ( 61,540 ) $ ( 57,033 )
Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities:
Depreciation, amortization and accrued contingencies
( 3,072 ) 1,140
Retirement pension obligations
58 58
Expenses related to share-based payments
8
4,800 3,416
Other elements
23 ( 3 )
Changes in operating assets and liabilities:
Decrease (increase) in other current assets
( 5,850 ) 20,900
(Decrease) increase in trade payables
1,691 5,699
(Decrease) increase in other current and
non-current
liabilities
( 2,547 ) ( 3,405 )
Change in operating lease liabilities and right of use assets
471 ( 2,554 )
Net cash flow provided by (used in) operating activities
( 65,967 ) ( 31,781 )
Cash flows provided by (used in) investing activities:
Acquisitions of property, plant, and equipment, net from proceeds
( 325 ) ( 742 )
Proceeds from property, plant, and equipment dispositions
— 3
Acquisitions of
non-current
financial assets
( 54 ) ( 149 )
Proceeds from
non-current
financial assets dispositions
( 242 ) 822
Net cash flows provided by (used in) investing activities
( 621 ) ( 66 )
Cash flows provided by (used in) financing activities:
Decrease in conditional advances
— ( 479 )
Treasury shares
54 149
Capital increases, net of transaction costs
6,902 194,732
Other cash flows related to financing activities
— —
Net cash flows provided by (used in) financing activities
6,956 194,403
Effect of exchange rate changes on cash and cash equivalents
( 427 ) ( 27,186 )
Net increase (decrease) in cash and cash equivalents
( 60,059 ) 135,369
Net Cash and cash equivalents at the beginning of the period
209,194 77,301
Net cash and cash equivalents at the end of the period
3
$ 149,135 $ 212,670
The accompanying notes are an integral part of these condensed consolidated financial statements.
7

DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)
(amounts in thousands, except share and per share data)

Ordinary shares
Number of
Shares
Amount
Additional
paid-in
capital
Treasury
stock
Accumulated
deficit
Accumulated
other
comprehensive
income (loss)
Accumulated
currency
translation
effect
Total
Shareholders’
Equity
Balance at January 1, 2022
55,095,762 $ 6,538 $ 358,115 $ ( 1,232 ) $ ( 258,528 ) $ 519 $ ( 6,137 ) $ 99,274
Net (loss)
— — — — ( 16,706 ) — — ( 16,706 )
Other comprehensive income (loss)
— — — — — 24 ( 1,933 ) ( 1,909 )
Issuance of ordinary shares
775 1 — — — — — 1
Treasury shares
— — — 40 — — — 40
Share-based payments
— — 1,363 — — — — 1,363
Other change in equity
— — — — 15 — ( 15 ) —
Balance at March 31, 2022
55,096,537 $ 6,539 $ 359,478 $ ( 1,193 ) $ ( 275,219 ) $ 543 $ ( 8,086 ) $ 82,062
Net (loss)
— — — — ( 23,039 ) — — ( 23,039 )
Other comprehensive income (loss)
— — — — — 200 ( 11,394 ) ( 11,194 )
Issuance of ordinary shares
38,926,142 4,170 103,007 — — — — 107,176
Issuance of warrants
— — 88,094 — — — — 88,094
Treasury shares
— — — 240 — — — 240
Share-based payments
— — 1,078 — — — — 1,078
Allocation of accumulated net losses
— — ( 95,209 ) — 95,209 — — —
Balance at June 30, 2022
94,022,679 $ 10,708 $ 456,447 $ ( 953 ) $ ( 203,050 ) $ 743 $ ( 19,480 ) $ 244,416
Net (loss)
— — — — ( 17,287 ) — — ( 17,287 )
Other comprehensive income (loss)
— — — — — 41 ( 15,425 ) ( 15,384 )
Issuance of ordinary shares
2,762 1 ( 539 ) — — — — ( 539 )
Issuance of warrants
— — — — — — — —
Treasury shares
— — — ( 130 ) — — — ( 130 )
Share-based payments
— — 976 — — — — 976
Allocation of accumulated net losses
— — — — — — — —
Balance at September 30, 2022
94,025,441 $ 10,709 $ 456,884 $ ( 1,083 ) $ ( 220,337 ) $ 783 $ ( 34,904 ) $ 212,052
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
Net (loss)
— — — — ( 24,243 ) — — ( 24,243 )
Other comprehensive income (loss)
— — — — — ( 10 ) ( 221 ) ( 232 )
Issuance of ordinary shares
2,103,635 231 7,535 — — — — 7,766
Treasury shares
— — — 42 — — — 42
Share-based payments
— — 1,814 — — — — 1,814
Allocation of accumulated net losses
— — ( 93,441 ) — 93,441 — — —
Balance at June 30, 2023
96,250,954 $ 10,952 $ 375,759 $ ( 1,082 ) $ ( 210,940 ) $ 687 $ ( 11,136 ) $ 164,240
Net (loss)
— — — — ( 16,736 ) — — ( 16,736 )
Other comprehensive income (loss)
— — — — — 73 ( 3,996 ) ( 3,922 )
Issuance of ordinary shares
2,599 1 ( 864 ) — — — — ( 864 )
Treasury shares
— — — ( 81 ) — — — ( 81 )
Share-based payments
— — 1,354 — — — — 1,354
Allocation of accumulated net losses
— — — — — — — —
Balance at September 30, 2023
96,253,553 $ 10,953 $ 376,249 $ ( 1,163 ) $ ( 222,676 ) $ 761 $ ( 15,132 ) $ 143,991
The accompanying notes are an integral part of these condensed consolidated financial statements.
8

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Note 1: The Company
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin
™
. 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 2, 2023 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2022 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, 2022.
Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2023, or any other future period.
Use of estimates
The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.
On an
on-going
basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets—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.
Accounting Pronouncements adopted in 2023
In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU
2016-13—Financial
Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU
2019-10
which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. Adoption of this new standard did not have a material impact on the consolidated financial statements.
In October 2021, the FASB issued ASU
2021-08,
which amends ASC 805 to require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination. This amendment is effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Adoption of this new standard has no impact on the consolidated financial statements.
9

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
Cur
r
ent
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, 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 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.
10

In 2022, the Company announced the new Phase 3 pivotal study for modified Viaskin Peanut (mVP) patch would be in younger
(4-7
years old) and more sensitive children with peanut allergy.
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 we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol. The Company further announced it plans to initiate a separate,
six
-month
safety study in approximately 275 additional subject
s
, randomized 3:1 active versus placebo, to supplement the safety data generated by the VITESSE trial, resulting in a safety database of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut.
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 in the first half of 2024 and topline results in the first half of 2025.
On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children
1-3
years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the
pre-specified
criteria for success for the primary endpoint, not requesting any additional efficacy study. The 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 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 expects both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE.
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”) of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
On December 20, 2021, the Company announced it had withdrawn the Marketing Authorization Application (“MAA”) for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by 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, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 µg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021.
11

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.
On April 19, 2023, the Company announced it will begin a new safety study after it received confirmation from the FDA that the EPITOPE study meets the
pre-specified
criteria for success for the primary endpoint, with no additional efficacy study requested. This safety study will increase the safety data collected from EPITOPE in support of a BLA. It will also generate patch adhesion data and 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.
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. 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 we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and
start-up
activities for prompt study launch once the partial clinical hold was lifted.
On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The 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 in the first half of 2024 and topline results in the first half of 2025.
Financing
In June 2023, the Company issued and completed sales of new ordinary shares (the “Ordinary Shares”) in the form of American Depositary Shares (“ADSs”), for a total gross amount of $ 7.8 million (and a net amount of $ 6.9 million after $ 0.9
capital
increase fees imputation), under the
At-The-Market
(“ATM”) program established in May 2022. In this context, 2,052,450 new Ordinary Shares in the form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.90 dollar per ADS (i.e., a subscription price per Ordinary Share of 3.52 euro based on the USD/EUR exchange rate of 1.0809 dollar for 1 euro, as published by the European Central Bank on June 14, 2023) and each ADS giving the right to receive
one-half
of one ordinary share of the Company.
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.
1
2
Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of September 30, 2023 and December 31, 2022:
September 30,
2023 		December 31,
2022
Cash
18,927 30,104
Cash equivalents
130,208 179,090
Total cash and cash equivalents as reported in the statements of financial position
149,135 209,194
Bank overdrafts
— —
Total cash and cash equivalents as reported in the statements of cash flows
149,135 209,194
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.
Note 4 Other Current Assets
Other current assets consisted of the following:
September 30,
2023 		December 31,
2022
Research tax credit
10,622 5,792
Other tax claims
4,571 3,903
Prepaid expenses
3,195 2,680
Other receivables
1,748 1,504
Total
20,136 13,880
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, 2023
5,792
+ Operating revenue
4,978
- Payment received
—
- Adjustment and currency translation effect
( 148 )
Closing research tax credit receivable as of September 30, 2023
10,622
Of which -
Non-current
portion
—
Of which - Current portion
10,622
Before currency translation effect, the balance in research tax credit as of September 30, 2023, consisted of $ 5.8 million research tax credit for the 2022 fiscal year filed with the tax authorities and yet to be reimbursed, and $ 5.0 million estimated research tax credit for the first nine months of the 2023 fiscal year.
The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.
1
3
Note 5 Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of September 30, 2023 and December 31, 2022, are as follows:

September 30, 2023
December 31, 2022
Other
Other
Real estate
assets
Total
Real estate
assets
Total
Current portion
1,592 73 1,665 1,972 79 2,051
Year 2
103 24 127 1,168 74 1,243
Year 3
— — — 65 6 71
Thereafter
— — — — — —
Total minimum lease payments
1,695 97 1,792 3,204 160 3,364
Less: Effects of discounting
( 167 ) ( 9 ) ( 176 ) ( 325 ) ( 17 ) ( 343 )
Present value of operating lease
1,528 88 1,616 2,879 143 3,021
Less: current portion
( 1,451 ) ( 71 ) ( 1,522 ) ( 1,823 ) ( 71 ) ( 1,894 )
Long-term operating lease
77 17 94 1,055 72 1,127
Weighted average remaining lease term (years)
0.72 — 1.40 —
Weighted average discount rate
2.84 % 2.48 % 3.00 % 2.45 %
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:
September 30,
2023 2022
Operating lease expense
1,223 1,373
Net termination impact
( 92 ) ( 1,657 )
Supplemental cash flow information related to operating leases is as follows for the period September 30, 2023 and 2022:
September 30,
2023 2022
Cash paid for amounts included in the measurement of lease liabilities
Operating cash outflows related to operating leases
1,410 1,533
Note 6: Trade Payables and Other Current Liabilities
6.1 Trade Payables
Trade
payables increased by $ 2.2 million as of September 30, 2023, compared to December 31, 2022.
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each period presented.
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4
6.2 Other Liabilities
The following tables summarize the other liabilities as of September 30, 2023 and December 31, 2022:

September 30,
December 31,
2023
2022
Other current
liabilities
Other non-current

liabilities
Total
Other current
liabilities
Other non-current

liabilities
Total
Employee related liabilities
5,557 — 5,557 5,872 45 5,917
Deferred income
2,286 2,702 4,988 2,137 4,690 6,828
Tax liabilities
193 — 193 69 — 69
Other debts
635 — 635 1,131 — 1,131
Total
8,671 2,702 11,372 9,210 4,735 13,945
The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations. Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science.
Note 7: Shareholders’ equity
The share capital as of September 30, 2023 is set at the
amount
of € 9,625,355.30 ($ 10,953 thousands converted at historical rates). It is divided into 96,253,553 fully authorized, subscribed and
paid-up
ordinary shares with a par value of € 0.10 .
Pursuant to the authorization granted by the General Meeting of the Shareholders held on April 12, 2023 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2022, have been allocated to additional
paid-in
capital for € 88,091,118.04 .
Note 8:
Share-Based
Payments
The Board of Directors has been authorized by the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and
non-employee
warrants (Bons de Souscription d’Actions or “BSA”).
During
the nine months ended September 30, 2023, the Company granted 59,200 stock options and 35,800 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report.
Change in Number of BSA/SO/RSU:
Number of outstanding
BSA
SO
RSUs
Balance as of December 31, 2022
251,693 5,306,569 1,589,081
Granted during the period
— 59,200 35,800
Forfeited during the period
— ( 128,700 ) ( 123,382 )
Exercised/released during the period
— — ( 66,883 )
Expired during the period
— — —
Balance as of September 30, 2023
251,693 5,237,069 1,434,616
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5
Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:

Three Months
Ended September 30,
Nine Months
Ended September
30,
2023
2022
2023
2022
Research & development
SO ( 376 ) ( 337 ) ( 1,272 ) ( 1,002 )
RSU ( 85 ) ( 201 ) ( 614 ) ( 594 )
Sales & marketing
SO ( 25 ) 30 ( 78 ) ( 3 )
RSU ( 8 ) 20 ( 25 ) 4
General & administrative
SO ( 747 ) ( 423 ) ( 2,473 ) 1,599 )
RSU ( 106 ) ( 66 ) ( 337 ) ( 223 )
Total share-based compensation (expense)
( 1,345 ) ( 976 ) ( 4,800 ) ( 3,416 )
Note 9: Contingencies
The following tables summarize the contingencies as of September 30, 2023 and December 31, 2022:
September 30,
2023 		December 31,
2022
Current contingencies
4,596 3,944
Non-current
contingencies
11,553 16,680
Total contingencies
16,149 20,625
The changes in contingencies are as follows:
Pension
retirement
obligations 		Collaboration
agreement -
Loss at
completion 		Other
contingencies 		Total
At January 1, 2023
790 19,835 — 20,625
Increases in liabilities
58 — 796 854
Used liabilities
— — — —
Reversals of unused liabilities
— ( 5,325 ) — ( 5,325 )
Net interest related to employee benefits, and unwinding of discount
— — — —
Actuarial gains and losses on defined-benefit plans
19 — — 19
Currency translation effect
( 7 ) ( 16 ) — ( 24 )
At September 30, 2023
860 14,494 796 16,149
Of which Current
— 3,801 796 4,596
Of which
Non-current
860 10,693 — 11,553
The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report.
In 2022 and during the first nine months of 2023, the Company updated its measurement of progress of the Phase 2 clinical trial conducted as part of the collaboration and license agreement with Nestlé Health Sciences and updated the cumulative income recognized. The Company recognized a reversal of $ 5.3 million of the loss for completion recorded in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and income yet to be recognized for the completion of the PII.
The other contingencies mainly consisted of a provision for refurbishment amounting to the best estimate of costs to be incurred in case the Montrouge office lease agreement is not renewed at its July 2024 term expiration.
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6
Note 10: Operating income
The following table summarizes the operating income during the three and nine months ended September 30, 2023 and 2022:

Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
Research tax credit
1,237 1,407 4,978 4,467
Other operating income
1,134 668 1,875 1,681
Total
2,372 2,074 6,853 6,148
The increase in operating income for the nine months period was primarily due to the increase in the research and development costs eligible to research tax credit in France.
The Company recognizes as other operating income accrued revenues based on its updated measurement of progress of the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. Moreover, the loss for completion recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase 2 clinical trial was updated accordingly as of September 30, 2023 (see note 9 related to contingencies).
Note 11: Allocation of Personnel Expenses
The Company had an average of
97
employees during the nine months ended September 30, 2023, in comparison with an average of
85
employees during the nine months ended September 30, 2022.
The following table summarizes the allocation of personnel expenses by function during the three and nine months ended September 30, 2023 and 2022:

Three Months
Ended September 30,
Nine Months
Ended September 30,
2023
2022
2023
2022
Research and Development expenses
3,663 3,186 11,684 9,357
Sales and Marketing expenses
187 138 557 727
General and Administrative expenses
2,876 1,598 8,834 6,961
Total personnel expenses
6,724 4,922 21,075 17,045
The following table summarizes the allocation of personnel expenses by nature during the three and nine months ended September 30, 2023 and 2022:

Three Months
Ended September 30,
Nine Months
Ended September 30,
2023
2022
2023
2022
Wages and salaries
4,175 3,505 12,691 11,001
Social security contributions
962 634 2,846 2,141
Expenses for pension commitments
234 214 738 723
Employer contribution to bonus shares
— ( 406 ) — ( 236 )
Share-based payments
1,353 976 4,800 3,416
Total
6,724 4,922 21,075 17,045
The increase in personnel expenses was mainly due to recruitment of US employees partially offset by the departure of
non-US
employees, and the increase of charges related to share-base payments.
Note 12: Commitments
There were no significant changes in other commitments from those disclosed in Note 17 to the consoli
date
d financial statements included in the
Annual Report.
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7
Note 13: Relationships with Related Parties
The Company’s related parties exclusively consisted of the members of the Board of Directors and the members of the Executive Committee. As of September 30, 2023, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not significantly changed since December 31, 2022.
There were no new significant related-party transactions during the period nor any changes in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.
Note 14: Loss Per Share
Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three- and nine-month periods ended September 30, 2023 and 2022, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.
The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and nine months ended September 30, 2023 and 2022 indicated in number of potential shares:
Three Months Ended
September 30, 		Nine Months Ended
September 30,
2023 2022 2023 2022
Non-employee
warrants
251,693 251,693 251,693 251,693
Stock options
5,237,069 3,541,383 5,237,069 3,541,383
Restricted stock units
1,434,616 1,185,936 1,434,616 1,185,936
Prefunded warrants
28,276,331 28,276,331 28,276,331 28,276,331
Note 15: Events after the Close of the Period
The Company evaluated subsequent events that occurred after September 30, 2023, through
the d
ate the condensed consolidated financial statements were issued after their approval by the Board of Directors on October 31, 2023, and determined that there were significant events
that
require disclosure in such condensed consolidated financial statements:
On October 16
th
, 2023, the Company has announced the appointment of Virginie Boucinha as CFO effective as of November 6
th
, 2023, in replacement of Sébastien Robitaille leaving as of November 17
th
, 2023.
The Company and Nestlé Health Science entered into a termination letter agreement, effective October 30, 2023, terminating the collaboration agreement between the two parties and the PII clinical study. According to this agreement, upfront and milestones 1 to 3 are definitively acquired by DBV. The termination agreement may have other contractual and accounting consequences, due to the end of the study, including, potential impacts of termination with some related parties which the Company is currently assessing and will be accounted for as of December 31, 2023.

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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, 2022, included in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 2, 2023, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.

Overview

We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or EPITTM, 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 clinical program is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in nine clinical trials, including four Phase 2 trials and three completed Phase 3 trials. We recently completed a Phase 3 trial of Viaskin Peanut in children ages one to three with peanut allergy and we also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy.

On December 23, 2022, the Company announced it plans to initiate a separate, six-month safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo, to supplement the safety data generated by the VITESSE trial, resulting in a safety database of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut (COMFORT Children).

On March 7, 2023, the Company announced screening of the first patient in VITESSE. Screening of the last patient is anticipated in the first half in 2024 and topline results in the first half in 2025.

On April 19, 2023, the Company outlined the regulatory path for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study (COMFORT Toddlers) 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.

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. The 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 expects both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE.

Critical Accounting Policies and Significant Judgments and Estimates

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

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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 September 30, 2023 and 2022

The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended September 30, 2023 and 2022.

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

Operating income

$ 2,372 $ 2,074 297 14 %

Operating expenses

Research and development expenses

(13,795 ) (15,096 ) 1,301 (9 )%

Sales and marketing expenses

(663 ) (159 ) (504 ) 318 %

General and administrative expenses

(6,184 ) (4,839 ) (1,345 ) 28 %

Total Operating expenses

(20,642 ) (20,094 ) (548 ) 3 %

Financial income (expenses)

1,534 732 802 110 %

Income tax

— — — —

Net loss

$ (16,736 ) $ (17,287 ) 551 (3 %)

Basic/diluted Net loss per share attributable to shareholders

$ (0.17 ) $ (0.18 )

Operating Income

The following table summarizes our operating income during the three months ended September 30, 2023 and 2022:

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

Sales

— — — —

Other income

2,372 2,074 297 14 %

Research tax credit

1,237 1,407 (169 ) (12 %)

Other operating income

1,134 668 467 70 %

Total operating income

2,372 2,074 297 14 %

Our operating income is primarily generated from the French research tax credit (Crédit d’Impôt Recherche, or “CIR”), and revenues recognized as part of our collaboration agreement with Nestlé Health Science. We generated operating income of $2.4 million during the three months ended September 30, 2023 compared to $2.1 million during the three months ended September 30, 2022.

The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement.

Operating Expenses

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended September 30, 2023 and 2022:

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Three Months
Ended September 30,
Research and Development expenses 2023 2022 $ change % change

External clinical-related expenses

12,277 11,136 1,141 10 %

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

3,203 2,648 555 21 %

Share-based payment expenses

460 538 (78 ) (14 %)

Depreciation, amortization and other costs

(2,145 ) 774 (2,920 ) (377 %)

Total Research and Development expenses

13,795 15,096 (1,301 ) (9 %)

Research and Development expenses decreased by $1.3 million for the three months ended September 30, 2023, compared to the three months ended September 30, 2022, primarily due to the reversal of $4.2 million of the loss at completion recorded as depreciation, amortization and other costs on the Phase II clinical trial conducted as part of the collaboration agreement with Nestlé. During the three months ended September 30, 2023, there was a reduction of costs to be engaged to follow the achievement of upcoming milestones.

Decreases in impacts of the loss at completion were partially offset by the increase by $1.1 million in external clinical-related expenses as a result of differences in phasing of on-going clinical trials between the three months ended September 30, 2022 and the three months ended September 30, 2023 and the increase by $0.6 million in employee-related costs (excl. share-based payments) to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2023 and 2022:

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

External professional services

343 (279 ) 621 (223 )%

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

152 188 (37 ) (19 %)

Share-based payment expenses

32 (50 ) 82 (165 %)

Depreciation, amortization and other costs

136 299 (163 ) (55 %)

Total Sales and Marketing expenses

663 159 504 318 %

Sales and marketing expenses increased by $0.5 million for the three months ended September 30, 2023, compared to the three months ended September 30, 2022, due to an increase of external professional services.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2023 and 2022:

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

External professional services

840 1,292 (451 ) (35 %)

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

2,024 1,110 914 82 %

Share-based payment expenses

853 489 364 74 %

Depreciation, amortization and other costs

2,467 1,949 518 27 %

Total General and Administrative expenses

6,184 4,839 1,345 28 %

General and Administrative expenses increased by $1.3 million for the three months ended September 30, 2023, compared to the three months ended September 30, 2022, mainly due to increase by $0.9 million in employee-related costs (excluding share-based payments) to support General and Administrative expenses activities explained by the average number of employees increase. In addition, we recorded a provision amounting to $0.8 million as of September 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 term expiration.

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Financial income (expense)

Our financial income was $1.5 million for the three months ended September 30, 2023, compared to a financial income of $0.7 million for the three months ended September 30, 2022. This item mainly includes the financial income on our financial assets.

Income tax

Our income tax expense was nil for the three months ended September 30, 2023 and September 30, 2022.

Net loss

Net loss was $16.7 million for the three months ended September 30, 2023, compared to $17.3 million for the three months ended September 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.17 and $0.18 for the three months ended September 30, 2023 and 2022, respectively.

Comparison of the Nine Months Ended September 30, 2023 and 2022

The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the nine months ended September 30, 2023 and 2022.

Nine months ended September 30,
2023 2022 $ change % change

Operating income

$ 6,853 $ 6,148 705 11 %

Operating expenses

Research and development expenses

(47,448 ) (45,930 ) (1,518 ) 3 %

Sales and marketing expenses

(1,613 ) (1,659 ) 46 (3) %

General and administrative expenses

(22,304 ) (17,173 ) (5,130 ) 30 %

Total Operating expenses

(71,365 ) (64,762 ) (6,602 ) 10 %

Financial income (expense)

2,984 1,668 1,316 79 %

Income tax

(13 ) (87 ) 74 (85) %

Net loss

$ (61,540 ) $ (57,033 ) (4,507 ) 8 %

Basic/diluted Net loss per share attributable to shareholders

$ (0.65 ) $ (0.79 )

Operating Income

The following table summarizes our operating income during the nine months ended September 30, 2023 and 2022:

Nine months ended September 30,
2023 2022 $ change % change

Sales

— —

Other income

6,853 6,148 ,705 11 %

Research tax credit

4,978 4,467 ,511 11 %

Other operating income

1,875 1,681 ,194 12 %

Total operating income

6,853 6,148 ,705 11 %

Our operating income consisted of the French research tax credit (Crédit d’Impôt Recherche, or “CIR”), and revenues recognized as part of our collaboration agreement with Nestlé Health Science. We generated operating income of $6.9 million during the nine months ended September 30, 2023 compared to $6.1 million during the nine months ended September 30, 2022.

The increase in operating income was mainly due to the increase by $0.5 million in the French research tax credit as both eligible employee-related costs and eligible external clinical-related expenses increased to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

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The other operating income increased by $0.2 million for nine months ended September 30, 2023, after we updated the measurement of progress of the Phase II clinical trial conducted as part of the Nestlé’s collaboration agreement.

Operating Expenses

Research and Development Expenses

The following table summarizes our R&D expenses incurred during the nine months ended September 30, 2023 and 2022:

Nine Months Ended September 30,
Research and Development expenses 2023 2022 $ change % change

External clinical-related expenses

34,170 30,150 4,020 13 %

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

9,797 7,761 2,036 26 %

Share-based payment expenses

1,886 1,596 290 18 %

Depreciation, amortization and other costs

1,595 6,423 (4,827 ) (75 %)

Total Research and Development expenses

47,448 45,930 1,518 3 %

Research and Development expenses increased by $1.5 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to the increase by $4.0 million and by $2.0 million in external clinical-related expenses and in employee-related costs (excl. share- based payments) respectively, to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

Increases in both external clinical-related expenses and employee-related costs were partially offset by the reversal of $5.3 million of the loss at completion recorded as other costs on the Phase II clinical trial conducted as part of the collaboration agreement with Nestlé. During the nine months ended September 30, 2022, the loss at completion was impacted by additional clinical and production costs following increasing timing to achieve upcoming milestones. During the nine months ended September 30, 2023, there were reduction of costs to be engaged to follow the achievement of upcoming milestones.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2023 and 2022:

nine Months Ended September 30,
Sales and Marketing expenses 2023 2022 $ change % change

External professional services

691 243 449 185 %

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

454 728 (274 ) (38 %)

Share-based payment expenses

103 (1 ) 104 (10815 %)

Depreciation, amortization and other costs

365 690 (325 ) (47 %)

Total Sales and Marketing expenses

1,613 1,659 (46 ) (3 )%

Sales and marketing expenses decreased by $ 0.05 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to a decrease of employee-related costs following departures in the US and other costs offset by an increase of external professional services to support Sales and Marketing activities.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2023 and 2022:

Nine Months Ended September 30,
General and Administrative expenses 2023 2022 $ change % change

External professional services

6,352 4,171 2,182 52 %

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

6,023 5,139 884 17 %

Share-based payment expenses

2,811 1,822 989 54 %

Depreciation, amortization and other costs

7,117 6,042 1,075 18 %

Total General and Administrative expenses

22,304 17,173 5,130 30 %

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General and Administrative expenses increased by $5.1 million for the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022, mainly due to an increase by $2.2 million for one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded an increase by $0.9 million in employee-related costs to support General and Administrative activities and a provision amounting to $0.8 million as of September 30, 2023, as our best estimate of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 term expiration.

Financial income (expense)

Our financial income was $3.0 million for the nine months ended September 30, 2023, compared to a financial income of $1.7 million for the nine months ended September 30, 2022. This item mainly includes financial income on our financial assets.

Income tax

Our income tax expense was nil for the nine months ended September 30, 2023 and September 30, 2022.

Net loss

Net loss was $ 61.5 million for the nine months ended September 30, 2023, compared to $57.0 million for the nine months ended September 30, 2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.65 and $0.79 for the nine months ended September 30, 2023 and 2022, respectively.

Liquidity and Capital Resources

Financial Condition

On September 30, 2023, we had $149.1 million in cash and cash equivalents compared to $209.2 million of cash and cash equivalents on December 31, 2022. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $66.0 million and $31.8 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, we recorded a net loss of $ 61.5 million. Our net cash flows provided by financing activities were $7.0 million during the nine months ended September 30, 2023 that consisted of the ATM program compared to $194.4 million during the nine months ended September 30, 2022, that consisted of the May 2022 ATM and June 2022 PIPE offering.

Our unaudited condensed consolidated financial statements have been prepared on a going concern basis assuming that based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents at closing date will be sufficient to fund our operations for at least the next 12 months. As such, no adjustments have been made to the unaudited condensed consolidated financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.

Sources of Liquidity and Material Cash Requirements

We have incurred net losses each year since our inception. Substantially all of our 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.

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

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

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

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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

Our corporate headquarters are located in Montrouge, France. Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 3, 2015, and represents a $1.2 million cash requirement as of September 30, 2023 which expires July 31, 2024.

Our primary U.S. office is located in Basking Ridge, New Jersey. In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 5,799 square feet in Basking Ridge, New Jersey. The Basking Ridge office represent a $0.1 million cash requirement as of September 30, 2023 which expires June 1, 2025.

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.

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 nine months ended September 30, 2023 and 2022.

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

Net cash flow used in operating activities

(65,967 ) (31,781 ) (34,186 ) 108 %

Net cash flow used in investing activities

(621 ) (66 ) (555 ) 839 %

Net cash flow provided by financing activities

6,956 194,403 (187,447 ) -96 %

Effect of exchange rate changes on cash and cash equivalents

(427 ) (27,186 ) 26,759 -98 %

Net (decrease) increase in cash and cash equivalents

(60,059 ) 135,369 (195,429 ) -144 %

Operating Activities

Our net cash flows used in operating activities were $66.0 million and $31.8 million during the nine months ended September 30, 2023 and 2022, respectively. Our net cash flows used in operating activities increased by $ 34.2 million, mainly due to the repayment in 2022 of the research tax credit receivable relating to fiscal years 2019 to 2021 for €24.8 million (corresponding to $28.1 million on the basis of 2021 closing exchange rate). The increase is also explained by the change in trade payables during the nine months period ended September 30, 2023 compared to the nine months period ended September 30, 2022.

Investing Activities

Our net cash flows used in investing activities were $0.6 million and $0.1 million during the nine months ended September 30, 2023 and 2022, respectively.

Financing Activities

Our net cash flows provided by financing activities was $7.0 million during the nine months ended September 30, 2023 that consisted of the ATM in June 2023 compared to $194.4 million during the nine months ended September 30, 2022, that consisted of our May 2022 ATM and June 2022 PIPE offering in second quarter of 2022.

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Off-Balance Sheet Arrangements

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

Smaller Reporting Company Status

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

Item 3. Quantitative and Qualitative Disclosures About Market Risk

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 September 30, 2023, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’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.

PART II – Other information

Item 1. Legal Proceedings

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

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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 nine months ended September 30, 2023, we issued the following unregistered securities:

•

On March 23, 2023, the issuance of an aggregate of 10,174 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and

•

On May 19, 2023, the issuance of an aggregate of 2,500 ordinary shares to a non-U.S. employee upon settlement of RSUs; and

•

On May 22, 2023, the issuance of an aggregate of 14,364 ordinary shares to non-U.S. employees upon settlement of RSUs; and

•

On May 24, 2023, the issuance of an aggregate of 34,321 ordinary shares to U.S. and non-U.S. employees upon settlement of RSUs; and

•

On September 23, 2023, the issuance of an aggregate of 2,599 ordinary shares to U.S. and non-U.S. 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

Not applicable.

Item 6. Exhibits.

Exhibit Index

Exhibit

Description

Incorporated by Reference
Schedule/
Form 		File
Number 		Exhibit File
Date
3.1 By-laws (statuts) of the registrant (English translation) 10-Q 001-

36697

3.1 5/04/23
31.1 Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended
31.2 Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended
32.1* Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended
101.INS XBRL Instance Document
101.SCH XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document

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Exhibit

Description

Incorporated by Reference
Schedule/
Form 		File
Number 		Exhibit File
Date
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.

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: October 31, 2023 By:

/s/ Daniel Tassé

Daniel Tassé
Chief Executive Officer
(Principal Executive Officer)
Date: October 31, 2023 By:

/s/ Sébastien Robitaille

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

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