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 June 30, ~~2021~~2022

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

For the transition period from

Commission file number

001-36697

DBV TECHNOLOGIES S.A.

(Exact name of registrant as specified in its charter)


France		Not ~~applicabl~~applicaeble
State or other jurisdiction of incorporation or organization		(I.R.S. Employer Identification No.)

177-181 avenue Pierre Brossolette Montrouge France		92120
(Address of principal executive offices)		(Zip Code)

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

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


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share	DBVT	The Nasdaq Stock Market LLC
Ordinary shares, nominal value €0.10 per share*	n/a	The Nasdaq Stock Market LLC

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

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

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past

90 days.

☒

Yes

☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation

S-T

(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

☒

Yes

☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a

non-accelerated

filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”

and ~~“emerging~~

“emerging growth company” in Rule

12b-2

of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer ~~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 ~~July 30, 2021,~~August 1

, 2022, the registrant had ~~55,011,687~~ 94,025,192

ordinary shares, nominal value €0.10 per share, ~~outstanding.~~outstanding including treasury shares.

Table of Contents

Table of contents


Part I	Financial information		~~Page~~3
~~Part I~~	~~Financial information~~ Item 1	2
~~Item 1~~	Condensed Consolidated Statements of Financial Position (Unaudited) as of June 30, ~~2021~~2022 and December 31, ~~2020~~2021	23
	Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Six Months Ended June 30, ~~2021~~2022 and ~~2020~~2021	34
	Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, ~~2021~~2022 and ~~2020~~2021	45
	Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Six Months Ended June 30, ~~2021~~2022 and ~~2020~~2021	56
	Notes to the Condensed Consolidated Financial Statements (Unaudited)	67
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1519
Item 3	Quantitative and Qualitative Disclosures About Market Risk	28
Item 4	Controls and Procedures	29

Part II	Other Information	2230
Item 41	~~Controls and Procedures~~Legal Proceedings	2230
~~Part II~~ Item 1A	~~Other information~~Risk Factors	30
Item 1	~~Legal Proceedings~~ 2	23
~~Item 1A~~	~~Risk Factors~~	23
~~Item 2~~	Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3	Defaults Upon Senior Securities	31
Item 4	Mine Safety Disclosures	31
Item 5	Other Information	2331
Item 36	~~Defaults Upon Senior Securities~~Exhibits	23
~~Item 4~~	~~Mine Safety Disclosures~~	23
~~Item 5~~	~~Other Information~~	23
~~Item 6~~	~~Exhibits~~	2432

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 ~~on Form 10-Q~~ are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report ~~on Form 10-Q~~ 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 ~~on Form~~

~~10-Q~~

~~(“Form~~

~~10-Q”)~~

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

~~statements regarding~~ the impact of the ongoing

COVID-19

pandemic, including the emergence of new variant strains of

COVID-19,

and its effects on our operations, research and development, ~~and~~ clinical trials and ability to obtain financing and potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers and collaborators with whom we conduct business;

our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated

re-submission

of a Biologics License Application, or a BLA, for Viaskin

Peanut to the U.S. Food and Drug ~~Administration;~~Administration, or the FDA;

the initiation, timing, progress and results of our

pre-clinical

studies and clinical trials, and our research and development programs;

~~the sufficiency of existing capital resources;~~

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.” ~~in our most recent Annual Report on Form 10-K and in any subsequent Quarterly Reports on Form 10-Q.~~

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Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, ~~on Form~~

~~10-Q,~~

these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form

10-K

for the year ended December 31, ~~2020,~~2021, filed with the Securities and Exchange Commission, ~~(“SEC”)~~or the SEC on March ~~17, 2021.~~9, 2022. Additional information is also included on our Current Report on Form

8-K,

filed with the SEC on June 13, 2022. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements.

In addition, any forward-looking statement in this Quarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on ~~Form 10-Q~~the relevant subject and represents our views only as of the date of this Quarterly Report ~~on Form 10-Q~~ 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.

Table of Contents

Part I – Financial Information

Item 1. Financial Statements

DBV Technologies S.A.

Condensed Consolidated Statements of Financial Position (unaudited)

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


			June 30,			December 31,				June 30,			December 31,
	Note		2021			2020			Note	2022			2021
Assets
Current assets :
Current assets:
Cash and cash equivalents		3	$	125,484		$	196,352		3	$	247,971		$	77,301
Trade receivables				—			2,230
Other current assets				13,107			8,792		4		11,981			37,085

Total current assets				138,592			207,375				259,953			114,386
Property, plant, and equipment, net				20,579			24,792				15,677			18,146
Right-of-use assets related to operating leases				8,630			10,104		5		3,146			7,336
Intangible assets				25			41				14			22
Other non-current assets				32,758			29,935				6,189			6,833

Total non-current assets				61,992			64,871				25,025			32,338

Total Assets			$	200,584		$	272,246			$	284,978		$	146,723

Liabilities and shareholders’ equity
Current liabilities:
Trade payables		4	$	16,335		$	20,338		6	$	16,341		$	11,429
Short-term operating leases				2,761			3,708		5		1,968			3,003
Short-term financial debt				710			724				156			510
Current contingencies		7		6,227			5,016		9		3,189			4,095
Other current liabilities		4		12,666			22,926		6		8,778			12,361

Total current liabilities				38,698			52,713				30,431			31,397

Long-term operating leases				9,155			10,496		5		1,945			7,147
Long-term financial debt				177			543
Non-current contingencies		7		6,064			2,527		9		6,421			6,758
Other non-current liabilities		4		3,471			475		6		1,764			2,147

Total non-current liabilities				18,867			14,042				10,130			16,052

Total Liabilities			$	57,565		$	66,754			$	40,562		$	47,449

Shareholders’ equity :
Ordinary shares, €0.10 par value; 55,011,687 and 54,929,187 shares authorized, and issued as at June 30, 2021 and December 31, 2020, respectively, and 3,943,548 and 4,029,763 shares outstanding as at June 30, 2021 and December 31, 2020, respectively			$	6,529		$	6,518
Shareholders’ equity:
Ordinary shares, €0.10 par value; 94,022,679 and 55,095,762 shares authorized, and issued as at June 30, 2022 and December 31, 2021, respectively										$	10,708		$	6,538
Additional paid-in capital				357,530			1,152,042				456,447			358,115
Treasury stock, 77,875 and 112,302 ordinary shares as of June 30, 2021 and December 31, 2020, respectively, at cost				(866	)		(1,169	)
Treasury stock, 106,287 and 153,631 ordinary shares as of June 30, 2022 and December 31, 2021, respectively, at cost											(953	)		(1,232	)
Accumulated deficit				(220,823	)		(958,543	)			(203,050	)		(258,528	)
Accumulated other comprehensive income				446			484				743			519
Accumulated currency translation effect				203			6,158				(19,480	)		(6,137	)

Total Shareholders’ equity		5	$	143,019		$	205,491		7	$	244,416		$	99,274

Total Liabilities and Shareholders’ equity			$	200,584		$	272,246			$	284,978		$	146,723

The accompanying notes are an integral part of these condensed consolidated financial statements.

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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 June 30,

Six Months Ended
June 30,


Note

2021

2020

2021

2020

Operating income


8


$
(1,488
)

$
3,610

$
1,453

$
8,330

Operating expenses

Research and development expenses
      (20,179 ) (21,932 ) (42,343 ) (49,464 )
Sales and marketing expenses
      (1,198 ) 778 (1,927 ) (6,519 )
General and administrative expenses
      (8,269 ) (8,862 ) (17,951 ) (19,975 )
Restructuring expenses
      —   (21,288 ) —   (21,288 )


Total Operating expenses
      (29,646 ) (51,305 ) (62,221 ) (97,246 )


Loss from operations


(31,134
)

(47,694
)

(60,768
)

(88,916
)


Financial income (expense)
      46 (506 ) 261 (196 )


Loss before taxes


(31,088
)

(48,200
)

(60,507
)

(89,112
)


Income tax
      434 (3 ) 404 (3 )


Net loss

$
(30,654
)

$
(48,203
)

$
(60,103
)

$
(89,115
)


Other comprehensive loss

Foreign currency translation differences, net of taxes
      2,788 6,363 (5,956 ) 299
Actuarial gains (losses) on employee benefits, net of taxes
      48 (227 ) (38 ) (38 )


Comprehensive loss

$
(27,818
)

$
(42,066
)

$
(66,097
)

$
(88,854
)


Basic/diluted net loss per share attributable to shareholders


11


$
(0.56
)

$
(0.88
)

$
(1.09
)

$
(1.67
)

Weighted average shares outstanding used in computing per share amounts:
      54,904,764 54,876,311 54,892,794 53,383,299

~~The accompanying notes are an integral part of these condensed consolidated financial statements.~~

~~Table of Contents~~

~~DBV Technologies S.A.~~

~~Condensed Consolidated Statements of Cash Flows (unaudited)~~

~~(amounts in thousands)~~

Six Months Ended June 30,


Notes

2021

2020

Net loss for the period

$
(60,103
)

$
(89,115
)
Adjustments to reconcile net loss to net cash used in operating activities:


Depreciation, amortization and accrued contingencies
      8,619 14,594
Retirement pension obligations
      57 (798 )
Expenses related to share-based payments


6

   2,527 (2,891 )
Other elements
      (843 ) 376
Changes in operating assets and liabilities:

Decrease (increase) in inventories and work in progress
      —   (1,433 )
Decrease (increase) in trade receivables
      2,175 6
Decrease (increase) in other current assets
      (8,393 ) (7,014 )
(Decrease) increase in trade payables
      (3,165 ) 1,691
(Decrease) increase in other current and
non-current
liabilities
      (6,608 ) (5,185 )
Change in operating lease liabilities and right of use assets
      (769 ) (78 )
Net cash flow used in operating activities


(66,503
)

(89,848
)


Cash flows used in investing activities:

Acquisitions of property, plant, and equipment, net from proceeds
      (13 ) (1,432 )
Acquisitions of intangible assets
      —   (11 )
Acquisitions of
non-current
financial assets
      —   (7 )


Net cash flows used in investing activities


(13
)

(1,450
)


Cash flows provided by financing activities:

(Decrease) increase in conditional advances
      (345 ) 19
Treasury shares
      638 (356 )
Capital increases, net of transaction costs
      794 151,029
Other cash flows related to financing activities
      (17 ) (19 )


Net cash flows provided by financing activities


1,071

150,672



Effect of exchange rate changes on cash and cash equivalents
      (5,423 ) 289


Net (decrease) increase in cash and cash equivalents


(70,868
)

59,663



Net Cash and cash equivalents at the beginning of the period
      196,352 193,255


Net cash and cash equivalents at the end of the period


3


$
125,484

$
252,917


		Three Months Ended June 30,						Six Months Ended June 30,
	Note	2022			2021			2022			2021
Operating income	10	$	1,529		$	(1,488	)	$	4,074		$	1,453
Operating expenses
Research and development expenses			(18,611	)		(20,179	)		(30,834	)		(42,343	)
Sales and marketing expenses			(1,037	)		(1,198	)		(1,500	)		(1,927	)
General and administrative expenses			(5,704	)		(8,269	)		(12,334	)		(17,951	)

Total Operating expenses			(25,352	)		(29,646	)		(44,669	)		(62,221	)

Loss from operations			(23,823	)		(31,134	)		(40,595	)		(60,768	)

Financial income			784			46			936			261

Loss before taxes			(23,039	)		(31,088	)		(39,659	)		(60,507	)

Income tax			—			434			(87	)		404

Net loss		$	(23,039	)	$	(30,654	)	$	(39,746	)	$	(60,103	)

Foreign currency translation differences, net of taxes			(11,394	)		2,788			(13,327	)		(5,956	)
Actuarial gains (losses) on employee benefits, net of taxes			200			48			224			(38	)

Total comprehensive loss		$	(34,234	)	$	(27,818	)	$	(52,849	)	$	(66,097	)

Basic/diluted net loss per share attributable to shareholders	14	$	(0.35	)	$	(0.56	)	$	(0.66	)	$	(1.09	)
Weighted average shares outstanding used in computing per share amounts:			66,047,949			54,904,764			60,490,075			54,892,794

The accompanying notes are an integral part of these condensed consolidated financial statements.

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DBV Technologies S.A.

Condensed Consolidated Statements of Cash Flows (unaudited)

(amounts in thousands)


		Six Months Ended June 30,
	Notes	2022			2021
Net loss for the period		$	(39,746	)	$	(60,103	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation, amortization and accrued contingencies			1,249			8,619
Retirement pension obligations			14			57
Expenses related to share-based payments	8		2,441			2,527
Other elements			(3	)		(843	)
Changes in operating assets and liabilities:
Decrease (increase) in trade receivables			—			2,175
Decrease (increase) in other current assets			23,436			(8,393	)
(Decrease) increase in trade payables			5,894			(3,165	)
(Decrease) increase in other current and non-current liabilities			(3,040	)		(6,608	)
Change in operating lease liabilities and right of use assets			(1,979	)		(769	)
Net cash flow used in operating activities			(11,733	)		(66,503	)

Cash flows used in investing activities:
Acquisitions of property, plant, and equipment, net from proceeds			(369	)		(13	)
Proceeds from property, plant, and equipment dispositions			3			—
Acquisitions of non-current financial assets			(279	)		—
Proceeds from non-current financial assets			426			—

Net cash flows used in investing activities			(218	)		(13	)

Cash flows provided by financing activities:
Decrease in conditional advances			(328	)		(345	)
Treasury shares			279			638
Capital increases, net of transaction costs			195,270			794
Other cash flows related to financing activities			—			(17	)

Net cash flows provided by financing activities			195,221			1,071

Effect of exchange rate changes on cash and cash equivalents			(12,600	)		(5,423	)

Net increase (decrease) in cash and cash equivalents			170,670			(70,868	)

Net Cash and cash equivalents at the beginning of the period			77,301			196,352

Net cash and cash equivalents at the end of the period	3	$	247,971		$	125,484

The accompanying notes are an integral part of these condensed consolidated financial statements.

Table of Contents

DBV Technologies S.A.

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

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


	Ordinary shares																						Ordinary shares
	Number of Shares		Amount		Additional paid-in capital			Treasury stock			Accumulated deficit			Accumulated other comprehensive income (loss)			Accumulated currency translation effect			Total Shareholders’ Equity			Number of Shares		Amount		Additional paid-in capital			Treasury stock			Accumulated deficit			Accumulated other comprehensive income (loss)			Accumulated currency translation effect			Total Shareholders’ Equity
Balance at January 1, 2020		47,028,510	$	5,645	$	1,003,595		$	(230	)	$	(798,988	)	$	108		$	(16,945	)	$	193,186
Balance at January 1, 2021																								54,929,187	$	6,518	$	1,152,042		$	(1,169	)	$	(958,543	)	$	484		$	6,158		$	205,491
Net (loss)		—		—		—			—			(40,913	)		—			—			(40,913	)		—		—		—			—			(29,449	)		—			—			(29,449	)
Other comprehensive income (loss)		—		—		—			—			—			189			(6,064	)		(5,875	)
Other comprehensive loss																								—		—		—			—			—			(85	)		(8,744	)		(8,829	)
Issuance of ordinary shares		7,898,677		873		150,150			—			—			—			—			151,023			7,500		1		42			—			—			—			—			42
Treasury shares		—		—		—			(832	)		—			—			—			(832	)		—		—		—			488			—			—			—			488
Share-based payments		—		—		3,073						—			—			—			3,073			—		—		1,433			—			—			—			—			1,433

Balance at March 31, 2020		54,927,187	$	6,518	$	1,156,818		$	(1,062	)	$	(839,901	)	$	297		$	(23,009	)	$	299,662
Balance at March 31, 2021																								54,936,687	$	6,519	$	1,153,516		$	(681	)	$	(987,992	)	$	399		$	(2,586	)	$	169,176
Net (loss)		—		—		—			—			(48,203	)		—			—			(48,203	)		—		—		—			—			(30,654	)		—			—			(30,654	)
Other comprehensive income (loss)		—		—		—			—			—			(227	)		6,363			6,136
Insuance of ordinary shares		—		—		—			—			—			—			—			—
Other comprehensive income																								—		—		—			—			—			48			2,788			2,836
Issuance of ordinary shares																								75,000		9		464			—			—			—			—			473
Insuance of warrants																												279															279
Treasury shares		—		—		—			107			—			—			—			107			—		—					(185	)		—			—			—			(185	)
Share-based payments		—		—		(5,964	)		—			—			—			—			(5,964	)		—		—		1,094						—			—			—			1,094
Allocation of accumulated net losses																								—		—		(797,823	)		—			797,823			—			—			—

Balance at June 30, 2020		54,927,187	$	6,518	$	1,150,855		$	(955	)	$	(888,103	)	$	70		$	(16,646	)	$	251,739
Balance at June 30, 2021																								55,011,687	$	6,529	$	357,530		$	(866	)	$	(220,823	)	$	446		$	203		$	143,019

Ordinary shares


Number of
Shares

Amount

Additional
paid-in

capital

Treasury
stock

Accumulated
deficit

Accumulated
other
comprehensive
income (loss)

Accumulated
currency
translation
effect

Total
Shareholders’
Equity

Balance at January 1, 2021


54,929,187


$
6,518


$
1,152,042

$
(1,169
)

$
(958,543
)

$
484

$
6,158

$
205,491

Net (loss)
   —      —      —   —   (29,449 ) —   —   (29,449 )
Other comprehensive loss
   —      —      —   —   —   (85 ) (8,744 ) (8,829 )
Insuance of ordinary shares
   7,500    1    42 —   —   —   —   42
Treasury shares
   —      —      —   488 —   —   —   488
Share-based payments
   —      —      1,433 —   —   —   —   1,433






Balance at March 31, 2021


54,936,687


$
6,519


$
1,153,516

$
(681
)

$
(987,992
)

$
399

$
(2,586
)

$
169,176

Net (loss)
   —      —      —   —   (30,654 ) —   —   (30,654 )
Other comprehensive income (loss)
   —      —      —   0 —   48 2,788 2,836
Issuance of ordinary shares
   75,000    9    464 —   —   —   —   473
Issuance of warrants
   —      —      279 —   —   —   —   279
Treasury shares
   —      —      —   (185 ) —   —   —   (185 )
Share-based payments
   —      —      1,094 —   —   —   —   1,094
Allocation of accumulated net losses
   —      —      (797,823 ) —   797,823 —   —   —






Balance at June 30, 2021


55,011,687


$
6,529


$
357,530

$
(866
)

$
(220,823
)

$
446

$
203

$
143,019


	Ordinary shares
	Number of Shares		Amount		Additional paid-in capital			Treasury stock			Accumulated deficit			Accumulated other comprehensive income (loss)		Accumulated currency translation effect			Total Shareholders’ Equity
Balance at January 1, 2022		55,095,762	$	6,538	$	358,115		$	(1,232	)	$	(258,528	)	$	519	$	(6,137	)	$	99,274
Net (loss)		—		—		—			—			(16,706	)		—		—			(16,706	)
Other comprehensive loss		—		—		—			—			—			24		(1,933	)		(1,909	)
Insuance of ordinary shares		775		1		—			—			—			—		—			1
Treasury shares		—		—		—			40			—			—		—			40
Share-based payments		—		—		1,363			—			—			—		—			1,363
Other changes		—		—		—			—			15					(15	)		—

Balance at March 31, 2022		55,096,537	$	6,539	$	359,478		$	(1,193	)	$	(275,219	)	$	543	$	(8,086	)	$	82,062
Net (loss)		—		—		—			—			(23,039	)		—		—			(23,039	)
Other comprehensive loss		—		—		—			—			—			200		(11,394	)		(11,194	)
Issuance of ordinary shares		38,926,142		4,170		103,007			—			—			—		—			107,176
Issuance of warrants		—		—		88,094			—			—			—		—			88,094
Treasury shares		—		—		—			240			—			—		—			240
Share-based payments		—		—		1,078			—			—			—		—			1,078
Allocation of accumulated net losses		—		—		(95,209	)		—			95,209			—		—			—

Balance at June 30, 2022		94,022,679	$	10,708	$	456,447		$	(953	)	$	(203,050	)	$	743	$	(19,480	)	$	244,416

The accompanying notes are an integral part of these condensed consolidated financial statements.

Table of Contents

NOTES TO THE FINANCIAL STATEMENTS (UNAUDITED)

Note 1: The

Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin

™

. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT

™

, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin

™

Basis of Presentation

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

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form

10-K

filed with the SEC on March ~~17, 2021~~9, 2022 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, ~~2020~~2021 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, ~~2020.~~2021.

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

Use of estimates

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

On an

on-going

basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets—operating lease, (4) impairment of

right-of-use

assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of contingencies.

~~Going concern~~

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

~~dit d~~

’

~~Imp~~

~~t Recherche~~

~~or “CIR”). 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 (the “FDA”) in connection with its Biologics License Application (“BLA”) for Viaskin~~

™

~~Peanut, beginning in August 2020, the Company scaled down its other clinical programs and~~

~~pre-clinical~~

~~spend to focus on Viaskin~~

™

~~Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin~~

™

Peanut in the United States and European Union. Based on guidance received from the FDA in January 2021, the Company’s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents

~~of $125.5 million as of June 30, 2021 will be sufficient to fund its operations for at least the next 12 months.~~

The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of

~~non-dilutive~~

~~financings. As a result of disruptions to the global financial markets due to the ongoing~~

~~COVID-19~~

~~pandemic, the Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. The ongoing~~

~~COVID-19~~

pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

~~Table of Contents~~

Accounting Pronouncements adopted in ~~2021~~2022

~~Effective January 1, 2021, the~~

The Company has not adopted ~~ASU~~

~~2019-12, Income~~

~~Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended~~any new accounting pronouncements in 2022 to ~~simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU~~

~~2019-12~~date.

~~did not have a material impact on the Company’s financial position or results of operations.~~

Accounting Pronouncements issued not yet adopted

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU

~~2016-13~~2016-13—Financial

~~- Financial Instruments -~~ Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU

2019-10

which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will have a material impact on its consolidated financial statements.

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.

Table of Contents

Note 2: Significant Events and Transactions

Clinical programs

Viaskin

Peanut for children ages

4-11

in the United States

In January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose (“ED”), which may decrease the chance of reacting to an accidental peanut exposure. After three years, the Company observed that 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three. The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients. During the PEOPLE trial, the most common adverse events were mild to moderate skin reactions localized to the administration site, and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without anti-anaphylactic treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment. Low discontinuations due to adverse events were observed.

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

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

~~On January 13,~~ 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. The Company believes the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDAComplete Response Letter received in ~~the CRL: the impact of patch adhesion and the need for patch modifications.~~August 2020. The FDA agreed with ~~the Company’s~~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 ~~patches, the~~patch, FDA ~~has~~ requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages ~~4 to 11 years.~~

4-11.

The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a

6-month,

well-controlled safety and adhesion trial to assess ~~the~~a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches

Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:

Identify a modified Viaskin patch (which the Company calls mVP).

Generate the

6-month

safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible.

Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies:

PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL

‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp;

In ~~the second quarter of~~March 2021, the Company ~~completed~~commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, ~~in order~~ to identify the ~~top performers.~~one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company ~~was pleased~~selected the modified patch to ~~learn that all~~advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the ~~current~~then-current Viaskin Peanut ~~patch. The~~patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development.

The ~~difference between~~Company then selected the ~~two selected patches~~circular patch for further development, which is ~~their shape—one is circular and the other is rectangular with rounded corners. They are both approximately 50%~~ larger ~~than~~in size relative to the current patch ~~but maintain~~and circular in shape.

In May 2021, the ~~same structure~~Company submitted its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.

After careful review of the ~~occlusion chamber (i.e., foam ring~~FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the

6-month

safety and ~~backing)~~adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company ~~also conducted advisory boards with patient caregivers~~considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and ~~key opinion leaders to obtain qualitative feedback on the consumer experience with both patches.~~

~~The Company submitted the protocol for STAMP (Safety, Tolerability and Adhesion of Modified Patches), the 6-month~~improved in vivo adhesion ~~and safety study~~ of the modified ~~patch, to the U.S. Food and Drug Administration (FDA) in the second quarter of 2021 and is currently awaiting feedback.~~

Earlier this quarter, the Company initiated PREQUAL, a Phase 1 study in healthy adult volunteers to optimize the allergen sample collection methodologies and validate the assays DBV intends to use in EQUAL (EQuivalence in the Uptake of ALlergen). The Company continues to work closely with FDA on how to best demonstrate the protein transport comparability of the modified patch (mVP) to the reference patch (cVP).

~~Viaskin~~

~~Peanut for children ages 4-11 in Europe~~

~~On November 2, 2020, the Company announced that its Marketi~~

~~Authorization Application, or MAA, for~~ Viaskin Peanut ~~had been validated by the European Medicines Agency, or EMA.~~system. The ~~validation of the MAA~~FDA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. The Company received the first set of questions from the EMA, during the first quarter of 2021, which were consistent with the Company’s ~~expectations~~change in strategy is agreeable via oral and written exchanges.

Table of Contents

The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and ~~prefiling conversations~~Efficacy), which means “speed” in French.

In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of the the Type C meeting briefing package.

DBV continues to engage in productive dialogue with the ~~EMA.~~FDA on the key elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.

Viaskin Peanut for children ages

4-11—European

Union Regulatory History and Current Status

In August 2021, the Company announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

In December 2021, the Company ~~did not receive questions about~~announced it has withdrawn the ~~impact~~Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of ~~adhesion~~our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES

(V712-301).

The decision to withdraw was based on ~~efficacy. The EMA’s~~the view of EMA Committee for Medicinal Products for Human Use ~~will provide~~(CHMP) that the data available to date from a ~~recommendation~~single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the ~~European Commission, or EC, on whether to grant~~review cycle. The Company believes data from a ~~marketing authorization when its review of the~~second Viaskin Peanut ~~MAA is complete.~~

~~In July 2021, the Company received from the EMA Day 180 list~~pivotal study will support a more robust path for licensure of ~~outstanding issues. The review of the Viaskin Peanut MAA is progressing according to established EMA processes and ongoing conversations with the EMA.~~

Many of EMA’s Objections and Major Objections have been answered; One Major Objection remains. The Company will provide a response to address the outstanding issues, including the mentioned Major Objection.

~~Based on the average length of an EMA evaluation of an MAA, the Company estimates the EMA could issue its decision on potential marketing authorization for~~ Viaskin Peanut in the ~~fourth quarter of 2021 or~~EU. The Company intends to resubmit the ~~first quarter of 2022.~~MAA when that data set is available.

Viaskin Peanut for children ages

1-3

OnIn June ~~26,~~ 2020, the Company announced

that in Part A, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 µgPg 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.~~2022.

In June 2022, the Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin

™

Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %).

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

Financing

~~On February 4, 2020,~~In May 2022, the Company announced that pursuant to the ~~closing~~Company’s

At-The-Market

program established in May 2022 (the “ATM Program”), it had issued and completed sales of ~~an underwritten global offering of an aggregate of 7,500,000~~new ordinary shares (the “Ordinary Shares”) in ~~(i) a public offering of 4,535,581 ordinary shares in the~~ form of ~~9,071,162~~ American Depositary Shares (“ADSs”), for a total gross amount of $15.3 million. In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the ~~United States, Canada and~~shareholders reserved to specific categories of persons fulfilling certain ~~countries outside Europe~~characteristics (the “ATM Issuance”), at a ~~public offering~~unit subscription price of ~~$10.25~~1.27 dollar per ADS ~~(on~~(i.e., a subscription price per Ordinary Share of 2.41 euro based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive

one-half

of one ordinary share of the Company).

In June 2022, the Company announced an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of ~~$1.0999~~$1.0739 = ~~€1.00), and (ii) an offering exclusively addressed to qualified investors in Europe (including France)~~€1.00 published by the European Central Bank on June 8, 2022) from the sale of ~~2,964,419~~32,855,669 ordinary shares, as well as

pre-funded

warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at ~~an offering~~a price ~~of €18.63~~ per ordinary share ~~(together,~~of €3.00 (corresponding to $3.22), and the ~~“Global Offering”).~~

pre-funded

~~On March 2, 2020,~~warrants were sold to the ~~Company announced that~~purchasers at a

pre-funded

price of €2.90 (corresponding to $3.11) per

pre-funded

warrant, which equals the ~~underwriters partially exercised their option to purchase 338,687 additional~~per share price for the ordinary shares inless the ~~form of 677,374 ADSs at an offering~~remaining €0.10 exercise price ~~of $10.25 per ADS,~~for each such

pre-funded

warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting ~~commissions and estimated offering expenses (the “Option”). The Option closed on March 4, 2020.~~

private placement expenses.

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

the ~~form of 9,748,536 ADSs, bringing the total gross proceeds~~ pre-funded warrants

from the ~~global offering to $160.7 million~~PIPE financing, have not been registered under the Securities Act of 1933, as amended, and ~~net proceeds of $150.0 million.~~

~~Restructuring~~

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

ordinary shares, including the ~~second~~ordinary shares underlying

the pre-funded warrants.

Table of Contents

Following the financing operations carried out in the first half of ~~2021.~~2022, the Company has cash and cash equivalent to support the Company’s operations several months beyond the projected completion of VITESSE, the planned Phase 3 clinical study of the modified Viaskin

™

Peanut patch in peanut allergic children ages 4 years and older.

~~The following table summarizes restructuring activities as of June 30, 2021 included in current contingencies and other current liabilities in the statement of financial position:~~


	Restructuring liabilities
~~Restructuring liability - January 1, 2021~~		~~9,387~~
~~Amounts paid~~		~~(6,285~~	)
~~Other effect including currency translation effect~~		~~(221~~	)

~~Restructuring liability – June 30, 2021~~		~~2,882~~

~~of which current contingencies~~		~~1,054~~
~~of which other current liabilities~~		~~1,828~~

COVID-19

Pandemic

On March 11, 2020, the World Health Organization declared

COVID-19

a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.

The Company has assessed the impact of the uncertainties created by the pandemic. As of June 30, ~~2021,~~2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the

COVID-19

pandemic are presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations according to the function or nature of the income or expense.

~~Table of Contents~~

Legal Proceedings

A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis

Ito-Stone

v. DBV Technologies, et al., Case No.

2:19-cv-00525.

The complaint alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, and its former Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule

10b-5

promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of purchasers of the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.

OnA hearing was held on July 29, 2021 ~~immediately after a hearing with the court,~~in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021.

On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the ~~Second~~Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ~~granted~~ordered the matter closed. Per court procedural rules, the Plaintiffs ~~until September~~have 30 days to ~~amend~~appeal the ~~complaint to try to cure~~dismissal of the ~~deficiencies.~~Third Amended.

The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously.

The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity.

Note 3: Cash and Cash Equivalents

The following tables summarize the cash and cash equivalents as of June 30, ~~2021~~2022 and December 31, ~~2020:~~2021:


	June 30,		December 31,		June 30,		December 31,
	2021		2020		2022		2021
Cash		47,640		42,341		226,674		31,427
Cash equivalents		77,844		154,011		21,298		45,874

Total cash and cash equivalents as reported in the statements of financial position		125,484		196,352		247,971		77,301

Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.

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Note 4 Other Current Assets

Other current assets consisted of the following:


	June 30,		December 31,
	2022		2021
Research tax credit		2,908		28,092
Other tax claims		4,339		3,561
Prepaid expenses		3,773		4,149
Other receivables		961		1,283

Total		11,981		37,085

Research tax credit

In the fiscal year ended December 31, 2021, the Company recovered its Small and

Medium-sized

Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.

During the six months period ended June 30, 2022, the Company received the reimbursement of the 2019, 2020 and 2021 fiscal year research tax credit.

The variance in Research Tax Credit is presented as follows:


	Amount in thousands of US Dollars
Opening research tax credit receivable as of January 1, 2022		28,092
+ Operating revenue		3,060
- Payment received		(27,119	)
- Adjustment and currency translation effect		(1,125	)

Closing research tax credit receivable as of June 30, 2022		2,908

Of which - Non -current portion		—
Of which - Current portion		2,908

The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.

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Note 5 Lease contracts

Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2022 and December 31, 2021, are as follows:


	June 30, 2022									December 31, 2021
	Real estate			Other assets			Total			Real estate			Other assets			Total
Current portion		2,104			50			2,154			3,361			77			3,438
Year 2		1,843			19			1,862			3,124			23			3,147
Year 3		284			11			295			2,299			18			2,317
Year 4		—			—			—			771			1			773
Year 5		—			—			—			790			—			790
Thereafter		—			—			—			1,220			—			1,220

Total minimum lease payments		4,231			80			4,311			11,565			119			11,684
Less: Effects of discounting		(363	)		(6	)		(370	)		(1,526	)		(8	)		(1,534	)

Present value of operating lease		3,868			73			3,941			10,039			111			10,150
Less: current portion		(1,922	)		(46	)		(1,968	)		(2,929	)		(74	)		(3,003	)

Long-term operating lease		1,946			27			1,973			7,110			37			7,147

Weighted average remaining lease term (years)		1.79			—						4.14			2.01
Weighted average discount rate		3.14	%		1.29	%					4.84	%		3.32	%

The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:


	June 30,
	2022			2021
Operating lease expense		950		1,698
Net termination impact		(1,657	)	—

In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income of $1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a

one-time

lump sum early termination fee of $1.5 million.

On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt will be recorded starting April 1, 2022 for a gross amount of 0.4 million.

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

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Note 4:6: Trade Payables and Other Current Liabilities

~~4.1~~6.1 Trade Payables

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

~~4.2~~6.2 Other Liabilities

The following tables summarize the other liabilities as of June 30, ~~2021~~2022 and December 31, ~~2020:~~2021:

June 30,

December 31,


2021

2020

Other current liabilities
   12,666    22,926
Other
non-current
liabilities
   3,471    475




Total


16,137



23,402


	June 30,						December 31,
	2022						2021
	Other current liabilities		Other non-current liabilities		Total		Other current liabilities		Other non-current liabilities		Total
Employee related liabilities		4,135		77		4,212		6,708		247		6,954
Deferred income		3,012		1,687		4,700		4,146		1,900		6,046
Tax liabilities		400		—		400		182		—		182
Other debts		1,231		—		1,231		1,325		—		1,325

Total		8,778		1,764		10,542		12,361		2,147		14,508

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~~The following table summarizes the other liabilities by nature as of June 30, 2021 and December 31, 2020:~~

June 30,

December 31,


2021

2020


Other current
liabilities

Other non-current

liabilities
   Total    Total
Employee related liabilities


6,815



1,624

   8,439    17,136
Deferred income


4,885



1,847

   6,732    4,687
Tax liabilities


85



—

   85    580
Other debts


881



—

   881    999








Total


12,666



3,471



16,137



23,402

The other current liabilities include short-term debt to employees including ~~employee termination allowance and benefits as part of the restructuring (refer to Note 2, “Significant Events and Transactions of the Period – Restructuring”), bonus accruals, and~~ social welfare and tax agency ~~obligations.~~obligations

Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to ~~$6.7~~$4.7 million as of June 30, ~~2021.~~2022.

Note 5:7: Shareholders’ equity

The share capital as of June 30, ~~2021~~2022 is set at the sum of ~~€5,501,168.70~~€9,402,268 ($~~6,528,543~~10,708,445 converted at historical rates). It is divided into ~~55,011,687~~94,022,679 fully authorized, subscribed and

paid-up

shares with a par value of €0.10.

~~During the six months ended June 30, 2021, the capital increase of approximately $10,000 is linked to the issuance of an aggregate of 82,500 shares pursuant to the exercise of warrants.~~

Pursuant to the authorization granted by the General Meeting of the Shareholders held on May ~~19, 2021,~~12, 2022 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, ~~2020~~2021 have been allocated to additional

paid-in

capital

Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2022 (the “Board General Meeting”):

decided, within the framework of the Issuance the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting which set out the characteristics included in the 18

resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of 6,113,200 New Ordinary Shares, corresponding to the maximum issue ceiling under the 22

resolution of the Board General Meeting;

granted a number of authorizations for the purpose of carrying out the Issuance;

b-delegated

its authority to the Chief Executive Officer for the purpose of implementing the financing.

The Chief Executive Officer, acting pursuant to the

sub-delegations

of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022 :

decided, making use of the 18

resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L.

225-128

of French Commercial Code, an amount of € 3,285,566.90, through the issuance of (i)

32,855,669

New Ordinary Shares, to be

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

decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10, by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of ~~€695,575,130.36 ($797,822,881 converted~~the

pre-financed

price released in advance at ~~historical rates).~~the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary;

determined the list of beneficiaries (designated within each of the categories of persons defined in the 18

resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the Issu

The Company has assessed the

pre-funded

warrants for appropriate equity or liability classification. During this assessment, the Company determined the

pre-funded

warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815.

The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return.

Accordingly, the

pre-funded

warrants are classified as equity and accounted for as a component of additional

paid-in

capital at the time of issuance.

The changes in number of outstanding prefunded warrants

are

as follows:


	Prefunded warrants
Balance as of December 31, 2021		—
Granted during the period		28,276,331
Forfeited during the period		—
Exercised/released during the period		—
Expired during the period		—

Balance as of June 30, 2022		28,276,331

Note 6:8: Share-Based Payments

The Board of Directors has been authorized by the SH General Meeting ~~of the Shareholders~~ to grant restricted stock units (“RSU”), stock options plan (“SO”), employee warrants (

Bons de Souscription de Parts de Créateur d’Entreprise

or “BSPCE”) and

non-employee

warrants (

Bons de Souscription d’Actions

or “BSA”).

During the six months ended June 30, ~~2021,~~2022, the Company granted ~~75,600~~19,000 stock options and ~~44,900~~3,200 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 1413 to the consolidated financial statements included in the Annual Report.

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Stock option fair value assumptions during the six months ended June 30, ~~2021~~2022

Weighted average share price at grant date in €	~~9.3~~2.42
Weighted average expected volatility	~~90.9~~92.4	%
Weighted average risk-free interest rate	~~(0.36~~0.86	)%
Weighted average expected term (in years)	6
Dividend yield	0——
Weighted average fair value of stock options in €	~~6.9~~

During the six months ended June 30, 2021, pursuant to the authorization granted by the General Meeting of the Shareholders held on May 19, 2021, the Company offered the directors the opportunity to subscribe for warrants to purchase ordinary shares on May 19, 2021, and on June 3, 2021, the directors subscribed for warrants to purchase an aggregate of 39,185 ordinary shares. These warrants have a contractual life of 4 years from their date of issuance and are not subject to a performance condition. Unless otherwise decided by the Board of Directors, these warrants may be exercised at any time prior to their expiration, provided that the beneficiary still holds a seat on the Board of Directors at the time of exercise, and subject to applicable French laws and regulations applicable to companies whose securities are listed on a regulated stock market. The fair value of the warrants has been estimated unsing the

~~Cox-Ross~~

~~Rubinstein binomial option pricing model.~~

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~~Warrant fair value assumptions during the six months ended June 30, 2021~~
~~Weighted average share price at grant date in €~~	~~10.75~~
~~Weighted average expected volatility~~	~~90.0~~	%
~~Weighted average risk-free interest rate~~	~~(0.53~~	)%
~~Weighted average expected term (in years)~~	~~3.21~~
~~Dividend yield~~	0—
~~Weighted average fair value of warrants in €~~	01.81

~~The changes~~Change in ~~number~~Number of BSA/~~BCE/~~SO/~~RSU are as follows:~~RSU:


	Number of outstanding
	BSA		SO			RSUs

Balance as of December 31, 2021		256,693		3,631,210			1,240,520
Granted during the period		—		19,000			3,200
Forfeited during the period		—		(205,728	)		(66,588	)
Exercised/released during the period		—		(2,125	)		(31,910	)
Expired during the period		—		—			—

Balance as of June 30, 2022		256,693		3,442,358			1,145,223

Number of outstanding


BSA

BCE

SO

RSUs

Balance as of December 31, 2020


218,008



5,500



2,610,510



1,118,745

Granted during the period
   39,185    —      75,600    44,900
Forfeited during the period
   —      —      (91,700 )    (71,200 )
Exercised/released during the period
   0    (5,500 )    —      —
Expired during the period
   (500 )    —      —      —








Balance as of June 30, 2021


256,693



0



2,594,410



1,092,445

Share-based payments expenses reflected in the condensed consolidated statements of ~~operations~~o

erations is as ~~follows:~~follow


	Three Months Ended June 30,								Six Months Ended June 30,							Three Months Ended June 30,						Six Months Ended June 30,
			2021			2020			2021			2020				2022			2021			2022			2021
Research & development		SO		(302	)		2,026			(678	)		1,149		SO		(290	)		(302	)		(665	)		(678	)
		RSU		115			(133	)		(136	)		(526	)	RSU		(185	)		115			(393	)		(136	)

Sales & marketing		SO		(63	)		2,475			(112	)		1,877		SO		(38	)		(63	)		(33	)		(112	)
		RSU		(26	)		(5	)		(48	)		(7	)
															RSU		(17	)		(26	)		(16	)		(48	)
General & administrative		SO		(709	)		1,655			(1,353	)		584		SO		(478	)		(709	)		(1,176	)		(1,353	)
		RSU		(110	)		(53	)		(201	)		(187	)	RSU		(70	)		(110	)		(157	)		(201	)

Total share-based compensation (expense)				(1,094	)		5,964			(2,527	)		2,891
Total share-based compensation (expens e )																	(1,078	)		(1,094	)		(2,441	)		(2,527	)

Note 7:9: Contingencies

The following tables summarize the contingencies as of June 30, ~~2021~~2022 and December 31, ~~2020:~~2021:


	June 30,		December 31,		June 30,		December 31,
	2021		2020		2022		2021
Current contingencies		6,227		5,016		3,189		4,095
Non-current contingencies		6,064		2,527		6,421		6,758

Total contingencies		12,291		7,542		9,610		10,853

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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, ~~2020,~~2021, included in our Annual Report on Form

10-K

for the year ended December 31, ~~2020,~~2021, filed with the Securities and Exchange Commission on March ~~17, 2021,~~9, 2022, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.

Overview

We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or EPIT

, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, as it targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat patients, including infants and children, suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered,

non-invasive

immunotherapy to patients. Our most advanced clinical program is Viaskin Peanut.

Viaskin

Peanut for children ages

4-11

in the United States

In January ~~13,~~ 2021, wethe Company received written responses from the FDA to questions provided in the Type A meeting request wethe Company submitted in October 2020 following the ~~CRL. We believe the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, we proposed potential resolutions to two main concerns identified by the FDA~~Complete Response Letter received in ~~the CRL: the impact of patch adhesion and the need for patch modifications.~~August 2020. The FDA agreed with ~~our~~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 aone peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified ~~patches, the~~patch, FDA ~~has~~ requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages ~~4 to 11 years.~~

4-11.

The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a

6-month,

Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:

Identify a modified Viaskin patch (which the Company calls mVP).

Generate the

6-month

PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL

‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp;

In March 2021, the ~~second quarter of 2021, we completed~~Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, ~~in order~~ to identify the ~~top performers.~~one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, ~~we were pleased~~the Company selected the modified patch to ~~learn that all~~advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the ~~current~~then-current Viaskin Peanut ~~patch. We~~patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape.

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In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.

After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the

6-month

safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.

The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.

The difference between the two selected patches is their shape—one is circular and the other is rectangular with rounded corners. They are both approximately 50% larger than the current patch but maintain the same structure of the occlusion chamber (i.e., foam ring and backing). We also conducted advisory boards with patient caregivers and key opinion leadersDBV continues to ~~obtain qualitative feedback on the consumer experience with both patches.~~

~~We submitted the protocol for STAMP (Safety, Tolerability and Adhesion of Modified Patches), the 6-month adhesion and safety study of the modified patch, to the U.S. Food and Drug Administration (FDA)~~engage in ~~the second quarter of 2021 and are currently awaiting feedback.~~

Earlier this quarter, we initiated PREQUAL, a Phase 1 study in healthy adult volunteers to optimize the allergen sample collection methodologies and validate the assays DBV intends to use in EQUAL (EQuivalence in the Uptake of ALlergen). We continue to work closelyproductive dialogue with the FDA on ~~how to best demonstrate~~ the ~~protein transport comparability~~key elements of the ~~modified patch (mVP) to~~VITESSE protocol. As previously disclosed, the ~~reference patch (cVP).~~Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.

Viaskin Peanut for children ages

4-11

- European Union Regulatory History and Current Status

~~ViaskinTM Peanut~~In August 2021, the Company announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in ~~Europe~~

~~During~~ the ~~first quarter~~process. The EMA indicated many of ~~2021, we received~~their objections and major objections from the ~~first set~~Day 120 list of questions ~~from~~had been answered. One major objection remained at Day 180. The Major Objection questioned the ~~European Medicines Agency, or EMA, regarding~~limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

In December 2021, the Company announced it has withdrawn the Marketing Authorization Application ~~or MAA,~~ for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as ~~a treatment for peanut allergy in children ages 4-11..~~ PEPITES

(V712-301).

The ~~questions were consistent with our expectations and prefiling conversations with~~decision to withdraw was based on the ~~EMA. We did not receive questions about the impact~~view of ~~adhesion on efficacy. The EMA’s~~EMA Committee for Medicinal Products for Human Use ~~will provide~~(CHMP) that the data available to date from a ~~recommendation~~single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the ~~European Commission, or EC, on whether to grant~~review cycle. The Company believes data from a ~~marketing authorization when its review of the~~second Viaskin Peanut ~~MAA is complete.~~

~~The European Medicines Agency (EMA) review~~pivotal study will support a more robust path for licensure of ~~the Viaskin Peanut Marketing Authorization Application (MAA) is progressing according to established EMA processes and ongoing conversations with the EMA.~~

In July 2021, we received from the EMA Day 180 list of outstanding issues. The review of the Viaskin Peanut MAA is progressing according to established EMA processes and ongoing conversations with the EMA.

~~Many of EMA’s Objections and Major Objections have been answered; One Major Objection remains. We will provide a response to address the outstanding issues, including the mentioned Major Objection.~~

~~Based on the average length of an EMA evaluation of an MAA, we estimate the EMA could issue its decision on potential marketing authorization for~~ Viaskin Peanut in the ~~fourth quarter~~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 ~~2021 or~~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 Pg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2022.

In June 2022, The Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin

™

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Critical Accounting Policies and Significant Judgments and Estimates

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

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

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Business trends and Results of Operations

Comparison of the Three Months Ended June 30, ~~2021~~2022 and ~~2020~~2021

The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended June 30, ~~2021~~2022 and ~~2020.~~2021.


	Three months ended June 30,						$ change			% change			Three months ended June 30,
	2021			2020									2022			2021			$ change			% change
Operating income	$	(1,488	)	$	3,610			(5,098	)		(141	)%	$	1,529		$	(1,488	)		3,016			(203	)%
Operating expenses
Research and development expenses		(20,179	)		(21,932	)		1,753			(8	)%		(18,611	)		(20,179	)		1,568			(8	)%
Sales and marketing expenses		(1,198	)		778			(1,976	)		(254	)%		(1,037	)		(1,198	)		162			(13	)%
General and administrative expenses		(8,269	)		(8,862	)		593			(7	)%		(5,704	)		(8,269	)		2,564			(31	)%
Restructuring expenses		—			(21,288	)		21,288			(100	)%

Total Operating expenses		(29,646	)		(51,305	)		21,658			(42	)%		(25,352	)		(29,646	)		4,309			(15	)%

Financial income (expense)		46			(506	)		552			(109	)%
Financial income														784			46			737	*

Income tax		434			(3	)		436				*		—			434			(434	)		(100	)%

Net loss	$	(30,654	)	$	(48,203	)		17,549			(36	)%	$	(23,039	)	$	(30,654	)		7,629			(25	)%

Basic/diluted Net loss per share attributable to shareholders													$	(0.35	)	$	(0.56	)

*	Percentage not meaningful

Operating Income

The following table summarizes our operating income during the three months ended June 30, ~~2021~~2022 and ~~2020:~~2021:


	Three months ended June 30,					$ change			% change			Three months ended June 30,
	2021			2020								2022		2021			$ change			% change
Sales		—			—		—			—			—		—			—			—
Other income		(1,488	)		3,610		(5,098	)		(141	)%		1,529		(1,488	)		3,016			(203	)%
Research tax credit		1,870			2,899		(1,028	)		(35	)%		1,491		1,870			(379	)		(20	)%
Other operating income		(3,358	)		712		(4,070	)		(572	)%		37		(3,358	)		3,396			(101	)%

Total operating income		(1,488	)		3,610		(5,098	)		(141	)%		1,529		(1,488	)		3,016			(203	)%

Table of Contents

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

~~Cré~~Cr

dit ~~d’Iimpô~~

’

Iimp

Recherche

, or “CIR”), and by the revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $1.5 million during the three months ended June 30, 2022 compared to $(1.5) million during the three months ended June 30, ~~2021 compared to $3.6 million during the three months ended June 30, 2020.~~2021. The ~~decrease~~increase in operating income is primarily attributable to ~~the change in~~ the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the three months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient ~~enrollment. The~~enrollment.The decrease in research tax credit is attributable to the decline of eligible expenses in connection with Research and Development costs.

~~Table of Contents~~

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the ~~during the~~ three months ended June 30, ~~2021~~2022 and ~~2020:~~2021:


	Three Months Ended June 30,					$ change			% change
	2021		2020									Three Months Ended June 30,
Research and Development expenses												2022		2021		$ change			% change
External clinical-related expenses		9,808		16,211			(6,403	)		(39	)%		11,664		9,808		1,856			19	%
Employee-related costs		3,206		3,998			(792	)		(20	)%		2,622		3,206		(584	)		(18	)%
Share-based payment expenses		187		(1,892	)		2,079			(110	)%		475		187		289			155	%
Depreciation, amortization and other costs		6,978		3,615			3,363			(93	)%		3,850		6,978		(3,128	)		(45	)%

Total Research and Development expenses		20,179		21,932			(1,753	)		(8	)%		18,611		20,179		(1,568	)		(8	)%

Research and Development expenses decreased by ~~$1.8~~$1.6 million for the three months ended June 30, ~~2021~~2022, compared to the three months ended June 30, ~~2020,~~2021, primarily due to ~~a decrease~~an increase in external clinical-related expenses ~~as a result~~following the launch of ~~budget~~work on VITESSE protocol. We have also continued to practice financial discipline ~~measures .~~ and implemented further cost containment strategies.

Employee-related costs, excluding share-based payment expenses, decreased by ~~$0.8~~$0.6 million for the three months ended June 30, ~~2021~~2022 compared to the three months ended June 30, ~~2020 directly related~~2021 due to the workforce reduction ~~we implemented as part~~following full implementation of ~~our 2020 global restructuring plan.~~the new organization.

The ~~shared-based payment income recognized for the three months ended June 30, 2020 was triggered by the reversal of share-based payment expenses due to employees’ departures~~decrease in ~~the context of our restructuring plan.~~

~~The increase of~~ depreciation, amortization and other ~~expenses relates~~costs was primarily due to the ~~change in the second quarter of 2021 in the accrual~~loss at completion recorded ~~in the amount of the difference between our current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of~~on the Phase II clinical trial conducted as part of the Nestlé agreement.

Table of Contents

Sales and Marketing expenses

The following table summarizes our sales and marketing ~~expensesincurred during the~~expenses incurred during the three months ended June 30, ~~2021~~2022 and ~~2020:~~2021:


	Three Months Ended June 30,					$ change			% change
	2021		2020									Three Months Ended June 30,
Sales and Marketing expenses												2022		2021		$ change			% change
External professional services		307		479			(172	)		(36	)%		399		307		92			30	%
Employee-related costs		430		1,105			(676	)		(61	)%		289		430		(140	)		(33	)%
Share-based payment expenses		89		(2,470	)		2,559			104	%		55		89		(34	)		(38	)%
Depreciation, amortization and other costs		373		107			265			247	%		294		373		(79	)		(21	)%

Total Sales and Marketing expenses		1,198		(778	)		1,976			254	%		1,037		1,198		(162	)		(13	)%

Sales and marketing expenses amounted to $1 million for the three months ended June 30, 2022, compared to $1.2 million for the three months ended June 30, ~~2021, compared to $(0.8)~~2021.

Employee-related costs, excluding share-based payments expenses, decreased by $0.1 million for the three months ended June 30, ~~2020.~~

The shared-based payment income recognized for the three months ended June 30, 2020 was triggered by the reversal of share-based payment expense due to employees’ departures in the context of our 2020 global restructuring plan.

~~The increase in share-based payment expense for the three months ended June 30, 2021~~2022, compared to the three months ended June 30, ~~2020 was partly offset by the decrease in employee-related costs, directly related~~2021 due to the workforce reduction ~~implemented as part~~following full implementation of ~~our restructuring plan. The decrease in external professional services for~~ the ~~three months ended June 30, 2021 compared to the three months ended June 30, 2020 is directly related to budget discipline measures taken.~~new organization.

~~Table of Contents~~

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the ~~during the~~ three months ended June 30, ~~2021~~2022 and ~~2020:~~2021:


	Three Months Ended June 30,					$ change			% change
	2021		2020									Three Months Ended June 30,
General and Administrative expenses												2022		2021		$ change			% change
External professional services		1,922		4,807			(2,884	)		(60	)%		1,771		1,922		(151	)		(8	)%
Employee-related costs		2,180		2,376			(196	)		(8	)%		2,220		2,180		40			2	%
Share-based payment expenses		819		(1,602	)		2,421			(151	)%		548		819		(271	)		(33	)%
Depreciation, amortization and other costs		3,348		3,281			67			2	%		1,166		3,348		(2,182	)		(65	)%

Total General and Administrative expenses		8,269		8,862			(593	)		(7	)%		5,704		8,269		(2,564	)		(31	)%

General and Administrative expenses decreased by ~~$0.6~~$2.6 million for the three months ended June 30, ~~2021~~2022, compared to the three months ended June 30, ~~2020 primarly~~2021 primarily due to a decrease in depreciation, amortization and other costs as we continued to practice financial discipline and implemented further cost containment ~~measures and decreased external professional fees.~~

The share-based payment income recognized for the three months ended June 30, 2020 was triggered by the reversal of share-based payment expense due to employees’ departures in the context of our 2020 global restructuring plan.

~~The decrease in employee-related costs, excluding share-based payments expenses, was directly related to the workforce reduction we implemented as part of our restructuring plan.~~

~~Restructuring~~

~~We initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin~~

™

~~Peanut in the United States and European Union. For the three months ended June 30, 2021, our average headcount was 99, compared to 306 for the three months ended June 30, 2020.~~

~~As of June 30, 2021, we had 97 employees. We expect full implementation of the organization-wide cost reduction measures to be completed in the second half of 2021.~~

The restructuring costs were mainly comprised of payroll expenses, restructuring-related consulting and legal fees, as well as impairment of facilities and right of use assets following resizing of facilities.

~~There were no restructuring costs for three months ended June 30, 2021.~~strategies.

Financial income (expense)

Our financial income was approximately $784,000 for the three months ended June 30, 2022, compared to a financial income of $46,000 for the three months ended June 30, ~~2021 compared to a financial expense of $0.5 million for the three months ended June 30, 2020.~~2021. This item mainly includes foreign exchange income and expenses.

Income tax

Our income tax profit was ~~$0.4~~nil for the three months ended June 30, 2022, compared to $0.1 million for the three months ended June 30, 2021. This profit mainly resulted from U.S. tax refunds.

Net loss

Net loss was $23 million for the three months ended June 30, 2022, compared to $30.7 million for the three months ended June 30, ~~2021, compared to $48.2 million for the three months ended June 30, 2020.~~2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was ~~$0.56~~$0.35 and ~~$0.88~~$0.56 for the three months ended June 30, ~~2021~~2022 and ~~2020,~~2021, respectively.

1823

Table of Contents

Business trends and Results of Operations

Comparison of the Six Months Ended June 30, ~~2021~~2022 and ~~2020~~2021

The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the six months ended June 30, ~~2021~~2022 and ~~2020.~~2021.

Six months ended
June 30,

$ change

% change


2021

2020




Operating income

$
1,453


$
8,330



(6,877
)


(83
)%
Operating expenses

Research and development expenses
   (42,343 )    (49,464 )    7,121    (14 )%
Sales and marketing expenses
   (1,927 )    (6,519 )    4,592    (70 )%
General and administrative expenses
   (17,951 )    (19,975 )    2,024    (10 )%
Restructuring expenses
   —      (21,288 )    21,288    (100 )%








Total Operating expenses
   (62,221 )    (97,246 )    35,025    (36 )%








Financial income (expense)
   261    (196 )    457    (233 )%








Income tax
   404    (3 )    407         *








Net loss

$
(60,103
)

$
(89,115
)


29,013



(33
)%

*	~~Percentage not meaningful~~


	Six months ended June 30,
	2022			2021			$ change			% change
Operating income	$	4,074		$	1,453			2,621			180	%
Operating expenses
Research and development expenses		(30,834	)		(42,343	)		11,509			(27	)%
Sales and marketing expenses		(1,500	)		(1,927	)		427			(22	)%
General and administrative expenses		(12,334	)		(17,951	)		5,617			(31	)%

Total Operating expenses		(44,669	)		(62,221	)		17,552			(28	)%

Financial income (expense)		936			261			675			258	%

Income tax		(87	)		404			(491	)		(122	)%

Net loss	$	(39,746	)	$	(60,103	)		20,357			(34	)%

Basic/diluted Net loss per share attributable to shareholders	$	(0.66	)	$	(1.09	)

Operating Income

The following table summarizes our operating income during the six months ended June 30, ~~2021~~2022 and ~~2020:~~2021:


	Six months ended June 30,					$ change			% change			Six months ended June 30,
	2021			2020								2022		2021			$ change			% change
Sales		—			—								—		—
Other income		1,453			8,330		(6,877	)		(83	)%		4,074		1,453			2,621			180	%
Research tax credit		3,677			5,800		(2,123	)		(37	)%		3,060		3,677			(617	)		(17	)%
Other operating income		(2,225	)		2,529		(4,754	)		(188	)%		1,014		(2,225	)		3,238			(146	)%

Total operating income		1,453			8,330		(6,877	)		(83	)%		4,074		1,453			2,621			180	%

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

Crédit d’Impôt Recherche

or “CIR”) and from revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $4.1 million during the six months ended June 30, 2022, compared to $1.5 million during the six months ended June 30, ~~2021, compared to $8.3 million during the six months ended June 30, 2020.~~ 2021.

The ~~decrease~~increase in operating income is primarily attributable to ~~the change in~~ the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the six months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient ~~enrollment.~~

~~The~~enrollment.The decrease in research tax credit is attributable to the decline in eligible expenses in connection with Research and Development costs.

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the six months ended June 30, ~~2021~~2022 and ~~2020:~~2021:


	Six Months Ended June 30,					$ change			% change
	2021		2020									Six Months Ended June 30,
Research and Development expenses												2022		2021		$ change			% change
External clinical-related expenses		22,686		29,319			(6,633	)		(23	)%		19,014		22,686		(3,672	)		(16	)%
Employee-related costs		7,297		12,934			(5,637	)		(44	)%		5,114		7,297		(2,183	)		(30	)%
Share-based payment expenses		814		(624	)		1,438			(231	)%		1,058		814		244			30	%
Depreciation, amortization and other costs		11,546		7,834			3,712			47	%		5,648		11,546		(5,898	)		(51	)%

Total Research and Development expenses		42,343		49,464			(7,121	)		(14	)%		30,834		42,343		(11,509	)		(27	)%

1924

Table of Contents

Research and Development expenses decreased by ~~$7.1~~$11.5 million for the six months ended June 30, ~~2021~~2022 compared to the six months ended June 30, ~~2020 primarly~~2021 primarily due to a decrease in external clinical-related expenses as ~~a result~~main component of ~~budget~~the work on clinical studies such as REALISE and EPITOPE has been finalized during the year 2021. We have also continued to practice financial discipline ~~measures .~~ and implemented further cost containment strategies.

Employee-related costs, excluding share-based payments expenses, decreased by ~~$5.6~~$2.2 million for the six months ended June 30, ~~2021,~~2022, compared to the six months ended June 30, ~~2020 directly related~~2021 due to the workforce reduction ~~we implemented as part of our 2020 global restructuring plan.~~

The shared-based payment income recognized for the six months ended June 30, 2020 was triggered by the reversal of share-based payment expenses due to employees’ departures in the context of our restructuring plan.

~~The increase in depreciation, amortization and other expenses relates primarily to the change in the second quarter of 2021 in the accrual recorded in the amount~~following full implementation of the difference between our current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial conducted as part of the Nestlé agreement.new organization.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the ~~during the~~ six months ended June 30, ~~2021~~2022 and ~~2020:~~2021:


	Six Months Ended June 30,					$ change			% change
	2021		2020									Six Months Ended June 30,
Sales and Marketing expenses												2022		2021		$ change			% change
External professional services		391		3,121			(2,729	)		(87	)%		521		391		130			33	%
Employee-related costs		877		4,702			(3,826	)		(81	)%		539		877		(338	)		(39	)%
Share-based payment expenses		159		(1,870	)		2,029			(109	)%		49		159		(110	)		(69	)%
Depreciation, amortization and other costs		500		566			(66	)		(12	)%		391		500		(109	)		(22	)%

Total Sales and Marketing expenses		1,927		6,519			(4,592	)		(70	)%		1,500		1,927		(427	)		(22	)%

Sales and marketing expenses decreased by ~~$4.6~~$0.4 million for the six months ended June 30, ~~2021~~2022, compared to the six months ended June 30, ~~2020, primarly~~2021, primarily due to a decrease in ~~external professional services as a result of budget discipline measures .~~ employee-related costs.

Employee-related costs, excluding share-based payments expenses, decreased by ~~$3.8~~$0.4 million for the six months ended June 30, ~~2021,~~2022, compared to the six months ended June 30, ~~2020 directly related~~2021 due to the workforce reduction ~~we implemented as part~~following full implementation of ~~our 2020 global restructuring plan.~~

~~The shared-based payment income recognized for~~ the ~~six months ended June 30, 2020 was triggered by the reversal of share-based payment expenses due to employees’ departures in the context of our restructuring plan.~~new organization.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the ~~during the~~ six months ended June 30, ~~2021~~2022 and ~~2020:~~2021:


	Six Months Ended June 30,					$ change			% change
	2021		2020									Six Months Ended June 30,
General and Administrative expenses												2022		2021		$ change			% change
External professional services		4,210		8,854			(4,644	)		(52	)%		2,879		4,210		(1,330	)		(32	)%
Employee-related costs		5,211		5,455			(244	)		(4	)%		4,029		5,211		(1,181	)		(23	)%
Share-based payment expenses		1,554		(397	)		1,951			491	%		1,333		1,554		(221	)		(14	)%
Depreciation, amortization and other costs		6,977		6,064			913			15	%		4,093		6,977		(2,884	)		(41	)%

Total General and Administrative expenses		17,951		19,975			(2,024	)		(10	)%		12,334		17,951		(5,617	)		(31	)%

General and Administrative expenses decreased by ~~$2.0~~$5.7 million for the six months ended June 30, ~~2021~~2022, compared to the six months ended June 30, ~~2020,~~2021, primarily due to ~~cost containment measures~~a decrease of depreciation, amortization and ~~decreased external professional fees.~~other costs.

The share-based payment income recognized for the six months ended June 30, 2020 was triggered by the reversal of share-based payment expense due to employees’ departures in the context of our 2020 global restructuring plan.

The decrease in employee-related costs, excluding share-based payment expenses, is directly related to the workforce reduction ~~we implemented as part of our restructuring plan.~~

~~Table of Contents~~

~~Restructuring~~

~~We initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of investigational Viaskin~~

™

~~Peanut in the United States and European Union. For the six months ended June 30, 2021, our average headcount was 111 compared to 311 for the six months ended June 30, 2020.~~

~~As of June 30, 2021, we had 97 employees. We expect~~following full implementation of the ~~organization-wide costs reduction measures to be completed in the second half of 2021.~~

new organization

~~There were no restructuring costs for six months ended June 30, 2021.~~

Financial income (expense)

Our financial income was $0.9 million for the six months ended June 30, 2022, compared to a financial income of $0.3 million for the six months ended June 30, ~~2021 compared to a financial expense of $0.2 million for the six months ended June 30, 2020.~~2021. This item mainly includes foreign exchange income (expense).

Income tax

Our income tax ~~profit~~expense was ~~$0.4 million~~$ 87,000 for the six months ended June 30, ~~2021.~~2022. This income tax profit mainly resulted from US tax refunds.

Table of Contents

Net loss

Net loss was $39.7 million for the six months ended June 30, 2022, compared to $60.1 million for the six months ended June 30, ~~2021, compared to $89.1 million for the six months ended June 30, 2020.~~2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was ~~$1.09~~$0.51 and ~~$1.67~~$1.09 for the six months ended June 30, 2022 and 2021, respectively.

Liquidity and Capital Resources

Financial Condition

On June 30, 2022, we had $248 million in cash and cash equivalents compared to $77.3 million of cash and cash equivalents on December 31, 2021. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $12.3 and $66.5 million for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, we recorded a net loss of $23 million.Our net cash flows provided by financing activities increased to $195.2 million during the six months ended June 30, 2022 from $1.1 million during the six months ended June 30, 2021. Financing activities consisted mainly of our underwritten global offering in the second quarter of 2022.

We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of

non-dilutive

financings. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.

Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives. As such, no adjustments have been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.

Sources of Liquidity and Material Cash Requirements

We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.

As of the date of the filing, our available cash is projected to be sufficient to support our operating plan for at least the next 12 months.

In May 2022, the Company announced that pursuant to the Company’s ATM program, it had issued and completed sales of new Ordinary Shares in the form of ADSs, for a total gross amount of $15.3 million.

In June 2022, the Company announced an aggregate $194 million PIPE financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 Ordinary Shares, as well as

pre-funded

warrants to purchase up to 28,276,331 Ordinary Shares.

We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing

COVID-19

pandemic. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

Table of Contents

The following table presents our material cash requirements for future periods:


	Material Cash Requirements Due by the period Ended June 30,
	2023		2024		2025		Thereafter		Total

	(Amounts in thousands)
Conditional advances		156		—		—		—		156
Operating leases		2,154		1,862		295		—		4,312
Purchase obligations - Obligations Under the Terms of CRO Agreements		17,057		6,721		4,969		—		30,586

Total		19,367		8,583		5,264		—		35,054

The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.

Future events could cause actual payments to differ from these estimates.

Conditional advances

In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV Technologies to help finance the pharmaceutical development of Viaskin

™

Milk. This amount was received in a single disbursement on November 27, 2014. In 2020, ~~respectively.~~due to the

COVID-19

pandemic, Bpifrance postponed the repayments for a

6-month

period. Repayment will end during the third quarter of 2022.

Operating leases

Our corporate headquarters are located in Montrouge, France. Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 3, 2015 and represents a $3.5 million cash requirement as of June 30, 2022 which expires March 8, 2024.

We also have facilities in North America that were initially intended to support our U.S. subsidiary as well as future commercialization needs. We lease 3,780 square feet of office space in Tower 49, New York, New York. This lease is for a period of 65 months and expires on February 25, 2023. In light of our global restructuring, the current stage of regulatory interactions regarding Viaskin Peanut, and the ongoing

COVID-19

pandemic, we entered into a sublease agreement of this office space in June 2021. The NYC office represents a $0.3 million cash requirement as of June 30, 2022 until the first quarter of 2023.

On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. The principal offices occupy a 5,799 square meter facility, and represents a $0.4 million cash requirement as of June 30, 2022 which expires May 1, 2025.

Purchase obligations - Obligations Under the Terms of CRO Agreements

In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations. Expenses associated with the ongoing trials amounted globally to $105.5 million. As of June 30, 2022, the amount we are still obligated to pay in connection with these contracts through 2024 is $30.6 million.

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Summary Statement of Cash Flows

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


	Six months ended June 30,						$ change			% of change			Six months ended June 30,
(Amounts in thousands of U.S. Dollars)	2021			2020									2022			2021			$ change			% of change
Net cash flow used in operating activities		(66,503	)		(89,848	)		23,345			(26	)%		(11,733	)		(66,503	)		54,770			(82	)%
Net cash flow used in investing activities		(13	)		(1,450	)		1,437			(99	)%		(218	)		(13	)		(206	)		1595	%
Net cash flow provided by financing activities		1,071			150,672			(149,601	)		(99	)%		195,222			1,071			194,151				*
Effect of exchange rate changes on cash and cash equivalents		(5,423	)		289			(5,712	)		*			(12,600	)		(5,423	)		(7,177	)		132	%

Net (decrease) increase in cash and cash equivalents		(70,868	)		59,663			(130,531	)		(219	)%		170,670			(70,868	)		241,538			(341	)%

*	Percentage not meaningful

Operating Activities

Our net cash flows used in operating activities were ~~$66.5~~$11.7 million and ~~$89.8~~$66.5 million during the six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, respectively. Our net cash flows used in operating activities ~~decreased~~increased by ~~$23.3~~$54.8 million, or ~~26.1%~~82%, mainly due to cost containment measures and ~~the decrease in personnel expenses related~~ to the workforce reduction ~~as part~~following full implementation of ~~our global restructuring plan.~~ the new organization

Cash flows used in operating activities for the six months ended June 30, 2021 ~~includes~~included restructuring costs paid for $6.3 million.

Investing Activities

Our net cash flows used in investing activities was approximately ~~$13,000~~$218,000 and ~~$1.5 million~~$13,000 during the six months ended June 30, ~~2021~~2022 and ~~2020,~~2021, respectively.

Financing Activities

Our net cash flows provided by financing activities ~~decreased~~increased to $195.2 million during the six months ended June 30, 2022 from $1.1 million during the six months ended June 30, ~~2021 from $150.7 million during the six months ended June 30, 2020.~~2021. Financing activities consisted mainly of our underwritten global offering in the ~~first~~second quarter ~~of 2020.~~

~~Based on our current assumptions, we expect that our current cash and cash equivalents will support our operations for at least 12 months and until the second half~~ of 2022.

Off-Balance

~~Table of Contents~~

~~Contractual Obligations and Other Commitments~~

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

~~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

Our market risks have not changed materially from those disclosed in ~~Item 7A of~~ the Annual Report.

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Item 4. Controls and Procedures

Disclosure Controls and Procedures

Based on its evaluation as of June 30, ~~2021,~~2022, our management, including our Chief Executive Officer and Chief Financial Officer,

concluded that our disclosure controls and procedures (as defined in Rule

13a-15(e)

under the Exchange Act) were effective to provide

reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules

13a-15(d)

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.

2229

Table of Contents

PART II – Other information

Item 1. Legal Proceedings

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

Item 1A. Risk Factors

~~There~~Except as set forth below, there have been no material changes in our risk factors from those disclosed in the Annual Report.

Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs.

As of December 31, 2021, 55,095,762 Ordinary Shares were issued and outstanding. Sales of a substantial number of shares of our Ordinary Shares or ADSs in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities. A substantial number of our shares are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act. If holders of these shares sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of our securities could decline significantly.

In June 2022, we completed a $194 million PIPE financing from the sale of (i) 32,855,669 Ordinary Shares, nominal value €0.10 per share at a price per Ordinary Share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and

(ii) pre-funded

warrants to purchase an aggregate of 28,276,331 Ordinary Shares (the “Warrant Shares”) at a

pre-funded

price per

pre-funded

warrant of €2.90 (corresponding to $3.11), which equals the per share price of the Ordinary Shares less the exercise price of €0.10 per

pre-funded

warrant. Each

pre-funded

warrant has an exercise price of €0.10 per Warrant Share. We entered into a registration rights agreement with the investors pursuant to which we agreed to file a registration statement with the SEC registering the resale of the 32,855,669 Ordinary shares and the 28,276,331 Ordinary shares underlying the

pre-funded

warrants issued in the PIPE. Upon the effectiveness of this registration statement and subject to certain beneficial ownership limitations contained in the

pre-funded

warrants, these shares will be freely tradable, without restriction, in the public market. In addition, the exercise of some or all of the

pre-funded

warrants will increase the number of our outstanding ordinary shares, which may dilute the ownership percentage or voting power of our shareholders.

In addition, we have filed a registration statement with the SEC to register the Ordinary Shares that may be issued under our equity incentive plans. The Ordinary Shares subject to outstanding options under our equity incentive plans, Ordinary Shares reserved for future issuance under our equity incentive plans and Ordinary Shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Sales of a large number of the shares issued under these plans in the public market could have an adverse effect on the market price of our securities.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

During the ~~three~~six months ended June 30, ~~2021,~~2022, we ~~granted 20,000 restricted stock units to employees in France.~~issued the following unregistered securities:

~~During~~

On March 23, 2022, the ~~three months ended June 30, 2021, pursuant~~issuance of an aggregate of 775 ordinary shares to a

non-U.S.

employee upon settlement of RSUs;

On May 19, 2022, the issuance of an aggregate of 5,000 ordinary shares to a

non-U.S.

employee upon settlement of RSUs;

On May 24, 2022, the issuance of an aggregate of 26,135 ordinary shares to a

non-U.S.

employee upon settlement of RSUs;

Pursuant to the authorization granted by the General Meeting of ~~our~~the Shareholders held on May ~~19, 2021, we~~12, 2022, the Company offered ~~our directors~~ the opportunity to subscribe for warrants to purchase ordinary shares on May ~~19, 2021,~~12, 2022, and on June ~~3, 2021,~~9, 2022, the ~~directors subscribed~~Chief Executive Officer authorized a capital increase for an amount of €3,285,566.90 through the issue of (i) 32,855,669 New Shares with a per value of €0.10 each and (ii) the issuance of 28,276,331 prefunded warrants, with cancellation of shareholders’ preferential subscription rights in favor of Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, existing shareholders of the Company and Venrock Healthcare Capital Partners.

On June 8, 2022, we entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to issue and sell to the investors i) 32,855,669 ordinary shares, nominal value €0.10 per share, at a price per ordinary share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022),

and (ii) pre-funded warrants

to purchase an aggregate of ~~39,185~~28,276,331 ordinary shares .(the “Warrant Shares”) at

a pre-funded price

per pre-funded warrant

of €2.90 (corresponding to $3.11), which equals the per share price of the ordinary shares less the exercise price of €0.10

per Pre-Funded Warrant.

Each Pre-Funded Warrant

has an exercise price of €0.10 per Warrant Share.

The Pre-Funded Warrants

are exercisable at any time after their original issuance and will expire ten years

~~During~~30

Table of Contents

following their issuance. The exercise price and number of shares of ordinary shares issuable upon exercise of the warrants may be adjusted in certain circumstances, including stock splits, stock dividends, reclassifications and the like. The

pre-funded

warrants issued in the PIPE provide that the holder of the

pre-funded

warrants will not have the right to exercise any portion of its

pre-funded

warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of ordinary shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”). The holder may increase or decrease the Beneficial Ownership Limitation, provided, however, that the holder may only increase the Beneficial Ownership Limitation by (i) obtaining authorization from the French Ministry of Economy in the event the Beneficial Ownership Limitation is being raised above 9.99%, and (ii) by providing 61 days’ notice to the Company, except that in no event will the Beneficial Ownership Limitation exceed 19.99%. The securities issued by us pursuant to the securities purchase agreement and to be issued upon exercise of the warrants were not registered under the Securities Act of 1933, as amended, or the Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

On June 10, 2022, the ~~three months ended June 30, 2021, we issued 75,000~~issuance of 3,100 ordinary shares ~~following the~~to a

non-U.S.

employee upon exercise of ~~warrants by a former in France,~~3,100 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of ~~$468,700.~~12,896 euros.

None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to

non-U.S.

resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

2331

Table of Contents

Item 6. Exhibits.

Exhibit Index

~~Exhibit~~

~~Description~~

~~Incorporated by Reference~~

Schedule/
Form

~~File~~

~~Number~~

~~Exhibit~~

~~File~~

~~Date~~

~~3.1~~

~~By-laws (statuts) of the registrant (English translation)~~

~~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~~

~~Inline X~~

~~BRL Instance Document~~

~~101.SCH~~

~~Inline X~~

~~BRL Taxonomy Extension Schema Document~~

~~101.CAL~~

~~Inline X~~

~~BRL Taxonomy Extension Calculation Linkbase Document~~

~~101.DEF~~

~~Inline X~~

~~BRL Taxonomy Extension Definition Linkbase Document~~

~~101.LAB~~

~~Inline X~~

~~BRL Taxonomy Extension Labels Linkbase Document~~

~~101.PRE~~

~~Inline X~~

~~BRL Taxonomy Extension Presentation Linkbase Document~~

~~104~~

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

Exhibit

Description

Incorporated by Reference

Schedule/
Form

File

Number

Exhibit

File

Date

1.1

Sales Agreement, dated as of May 2, 2022, by and between DBV Technologies S.A. and Jefferies LLC

Form

8-K

001-36697

1.1

May 2,
2022

3.1

Amended and Restated By-laws (statuts) of the registrant (English translation)

4.1

Terms and Conditions of the Pre-Funded Warrant

Form

8-K

001-36697

Annex II of
the
Securities
Purchase
Agreement
filed as
Exhibit 10.1

June 13,
2022

10.1

Registration Rights Agreement, dated June 8, 2022, by and between DBV Technologies S.A. and the investor parties thereto

Form 8-K

001-36697

10.2

June 13,
2022

10.2

Securities Purchase Agreement, dated June 8, 2022, by and between DBV Technologies S.A. and the investor parties thereto

Form

8-K

001-36697

10.1

June 13,
2022

31.1

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

31.2

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

32.1*

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

101.INS

XBRL Instance Document

101.SCH

XBRL Taxonomy Extension Schema Document

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

XBRL Taxonomy Extension Labels Linkbase Document

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document

104

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

Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form

10-Q),

irrespective of any general incorporation language contained in such filing.

2432

Table of Contents

SIGNATURES

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


	DBV Technologies S.A. ~~(Registrant)~~
	(Registrant)

Date: August ~~2, 2021~~1, 2022	By: ~~/s/~~	/s/ Daniel Tassé
		Daniel Tassé
		Chief Executive Officer
		(Principal Executive ~~officer)~~Officer)

Date: August ~~2, 2021~~1, 2022	By: ~~/s/~~	/s/ Sébastien Robitaille
		Sébastien Robitaille
		Chief Financial Officer
		(Principal Financial and ~~Accounting)~~Accounting Officer)

2533


	Pension retirement obligations			Collaboration agreement - Loss at completion			Other contingencies			Total
At January 1, 2021		937			3,956			2,649			7,542
Increases in liabilities		57			5,393			554			6,004
Used liabilities		—			0			(985	)		(985	)
Reversals of unused liabilities		—			—			—			0
Net interest related to employee benefits, and unwinding of discount		—			—			—			0
Actuarial gains and losses on defined-benefit plans		38			—			—			38
Other effects including currency translation effect		(31	)		(201	)		(78	)		(309	)

At June 30, 2021		1,001			9,148			2,142			12,291

Of which current		—			4,086			2,142			6,227
Of which non-current		1,001			5,063			—			6,064


	Three Months Ended June 30,					Six Months Ended June 30,
	2021		2020			2021		2020
Research and Development expenses		3,393		2,106			8,111		12,310
Sales and Marketing expenses		518		(1,364	)		1,036		2,833
General and Administrative expenses		2,999		775			6,765		5,058
Restructuring		0		7,023			0		7,023

Total personnel expenses		6,910		8,539			15,912		27,223


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021

Research and Development expenses		3,097		3,393		6,172		8,111
Sales and Marketing expenses		344		518		589		1,036
General and Administrative expenses		2,767		2,999		5,362		6,765

Total personnel expenses		6,208		6,910		12,123		15,912


	Three Months Ended June 30,					Six Months Ended June 30,
	2021		2020			2021		2020
Wages and salaries		4,382		13,229			8,836		26,101
Social security contributions		1,064		4,074			2,396		4,736
Expenses for pension commitments		293		(416	)		695		499
Employer contribution to bonus shares		77		(2,384	)		1,458		(1,222	)
Share-based payments		1,094		(5,964	)		2,527		(2,891	)

Total		6,910		8,539			15,912		27,223


	Number of outstanding
	BSA			BCE			SO			RSUs
Balance as of December 31, 2020		218,008			5,500			2,610,510			1,118,745
Granted during the period		39,185			—			75,600			44,900
Forfeited during the period		—			—			(91,700	)		(71,200	)
Exercised/released during the period		0			(5,500	)		—			—
Expired during the period		(500	)		—			—			—

Balance as of June 30, 2021		256,693			0			2,594,410			1,092,445


	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021

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

Cash paid for amounts included in the measurement of lease liabilities

Operating cash flows from operating leases