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    DBV   FR0010417345

DBV TECHNOLOGIES

(DBV)
  Report
Real-time Euronext Paris  -  11:35 2022-10-04 am EDT
3.454 EUR   +3.85%
07:34aDbv Technologies S.a. : Change in Directors or Principal Officers, Regulation FD Disclosure, Financial Statements and Exhibits (form 8-K)
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10/03DBV Technologies Announces Appointment of New Chair of its Audit Committee and Appointment of Daniele Guyot-Caparros to Board of Directors
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10/03DBV Technologies Announces Appointment of New Chair of its Audit Committee and Appointment of Daniele Guyot-Caparros to Board of Directors
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DBV TECHNOLOGIES S.A. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)

08/01/2022 | 04:52pm EDT
You should read the following discussion and analysis of our financial condition
and results of operations in conjunction with our unaudited condensed
consolidated financial statements and related notes included in Part 1, Item 1
of this Report and with our audited financial statements and related notes
thereto for the year ended December 31, 2021, included in our Annual Report on
Form
10-K
for the year ended December 31, 2021, filed with the Securities and Exchange
Commission on March 9, 2022, or the Annual Report. This discussion and other
parts of this Report contain forward-looking statements that involve risks and
uncertainties, such as statements of our plans, objectives, expectations and
intentions. Our actual results could differ materially from those discussed in
these forward-looking statements. Factors that could cause such differences are
discussed in the section of this Report titled "Special Note Regarding
Forward-Looking Statements" and under "Item 1A. Risk Factors" in the Annual
Report.

Overview


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

Viaskin
TM
Peanut for children ages
4-11
in the United States

In January 2021, the Company received written responses from the FDA to
questions provided in the Type A meeting request the Company submitted in
October 2020 following the Complete Response Letter received in August 2020. The
FDA agreed with its position that a modified Viaskin Peanut patch should not be
considered as a new product entity provided the occlusion chamber of the current
Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000
of one peanut) remains unchanged and performs in the same way it has performed
previously. In order to confirm the consistency of efficacy data between the
existing and a modified patch, FDA requested an assessment comparing the uptake
of allergen (peanut protein) between the patches in peanut allergic children
ages
4-11.
The Company named that assessment EQUAL, which stands for Equivalence in Uptake
of ALlergen. The FDA also recommended conducting a
6-month,
well-controlled safety and adhesion trial to assess a modified Viaskin Peanut
patch in the intended patient population. The Company later named this study
STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches

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


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



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



    6.   Demonstrate the equivalence in allergen uptake between the current and
         modified patches in the intended patient population via EQUAL. The
         complexity of EQUAL hinged on the lack of established clinical and

regulatory criteria to characterize allergen uptake via an epicutaneous

patch. To support those exchanges, the Company outlined its proposed

         approach to demonstrate allergen uptake equivalence between the two
         patches, and allotted time to generate informative data through two
         additional studies:


c. PREQUAL, a Phase I study with adult healthy volunteers to optimize the

            allergen sample collection methodologies and validate the assays we
            intend to use in EQUAL



        d.  'EQUAL in adults'-a second Phase I study with adult healthy volunteers
            to compare the allergen uptake of cVP and Mvp;


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

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

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

6-month


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

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


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

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

Viaskin Peanut for children ages

4-11

- European Union Regulatory History and Current Status


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

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

(V712-301).


The decision to withdraw was based on the view of EMA Committee for Medicinal
Products for Human Use (CHMP) that the data available to date from a single
pivotal study were not sufficient to preclude a Major Objection at Day 180 in
the review cycle. The Company believes data from a second Viaskin Peanut pivotal
study will support a more robust path for licensure of Viaskin Peanut in the EU.
The Company intends to resubmit the MAA when that data set is available.

Viaskin Peanut for children ages

1-3


In June 2020, the Company announced that in Part A, patients in both treatment
arms showed consistent treatment effects after 12 months of therapy, as assessed
by a double-blind placebo-controlled food challenge and biomarker results. Part
A subjects were not included in Part B and the efficacy analyses from Part A
were not statistically powered to demonstrate superiority of either dose versus
placebo. These results validate the ongoing investigation of the 250 Pg dose in
this age group, which is the dose being studied in Part B of the study.
Enrollment for Part B of EPITOPE was completed in the first quarter of 2022.

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

Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years,
met its primary endpoint. Viaskin Peanut demonstrated a 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.

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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.

Business trends and Results of Operations

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

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

                                            Three months ended June 30,
                                             2022                 2021             $ change         % change
Operating income                         $       1,529        $      (1,488 )          3,016             (203 )%
Operating expenses
Research and development expenses              (18,611 )            (20,179 )          1,568               (8 )%
Sales and marketing expenses                    (1,037 )             (1,198 )            162              (13 )%
General and administrative expenses             (5,704 )             (8,269 )          2,564              (31 )%

Total Operating expenses                       (25,352 )            (29,646 )          4,309              (15 )%

Financial income                                   784                   46              737 *

Income tax                                          -                   434             (434 )           (100 )%

Net loss                                 $     (23,039 )      $     (30,654 )          7,629              (25 )%

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



* Percentage not meaningful


Operating Income

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

                            Three months ended June 30,
                             2022                2021            $ change        % change
Sales                              -                    -               -               -
Other income                    1,529               (1,488 )         3,016            (203 )%
Research tax credit             1,491                1,870            (379 )           (20 )%
Other operating income             37               (3,358 )         3,396            (101 )%

Total operating income          1,529               (1,488 )         3,016            (203 )%




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Our operating income is primarily generated from the French research tax credit
(
Cr
é
dit
d
'
Iimp
ô
t
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. The increase in operating income is primarily
attributable to the revenue recognized under the Nestlé's collaboration
agreement, as we updated the measurement of progress of the Phase II clinical
trial conducted as part of the agreement. During the three months ended June 30,
2021 negative revenue was recognized under the Nestlé's collaboration agreement
due to delays in new patient enrollment.The decrease in research tax credit is
attributable to the decline of eligible expenses in connection with Research and
Development costs.

Research and Development Expenses

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


                                                  Three Months Ended June 

30,

Research and Development expenses                  2022                 2021           $ change       % change
External clinical-related expenses                    11,664                9,808          1,856             19 %
Employee-related costs                                 2,622                3,206           (584 )          (18 )%
Share-based payment expenses                             475                  187            289            155 %
Depreciation, amortization and other costs             3,850                

6,978 (3,128 ) (45 )%


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



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

Employee-related costs, excluding share-based payment expenses, decreased by $0.6 million for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.


The decrease in depreciation, amortization and other costs was primarily due to
the loss at completion recorded on the Phase II clinical trial conducted as part
of the Nestlé agreement.

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Sales and Marketing expenses

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


                                           Three Months Ended June 30,
Sales and Marketing expenses                2022                 2021             $ change         % change
External professional services                    399                  307               92               30 %
Employee-related costs                            289                  430             (140 )            (33 )%
Share-based payment expenses                       55                   89              (34 )            (38 )%
Depreciation, amortization and
other costs                                       294                  373              (79 )            (21 )%

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



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


Employee-related costs, excluding share-based payments expenses, decreased by
$0.1 million for the three months ended June 30, 2022, compared to the three
months ended June 30, 2021 due to the workforce reduction following full
implementation of the new organization.

General and Administrative expenses

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


                                                  Three Months Ended June 

30,

General and Administrative expenses                2022                 2021            $ change        % change
External professional services                         1,771                1,922            (151 )            (8 )%
Employee-related costs                                 2,220                2,180              40               2 %
Share-based payment expenses                             548                  819            (271 )           (33 )%
Depreciation, amortization and other costs             1,166                3,348          (2,182 )           (65 )%

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



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

Financial income (expense)

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

Income tax


Our income tax profit was nil for the three months ended June 30, 2022, compared
to $0.1 million for the three months ended 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. Net loss per share
(based on the weighted average number of shares outstanding over the period) was
$0.35 and $0.56 for the three months ended June 30, 2022 and 2021, respectively.

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Business trends and Results of Operations

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

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


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

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

Financial income (expense)                           936              261            675             258 %

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

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

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



Operating Income

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

                            Six months ended June 30,
                             2022               2021            $ change        % change
Sales                              -                   -
Other income                    4,074               1,453           2,621             180 %
Research tax credit             3,060               3,677            (617 )           (17 )%
Other operating income          1,014              (2,225 )         3,238            (146 )%

Total operating income          4,074               1,453           2,621             180 %



Our operating income was primarily generated from the French research tax credit
(
Crédit d'Impôt Recherche
or "CIR") and from revenue recognized under our collaboration agreement with
Nestlé Health Science. We generated operating income of $4.1 million during the
six months ended June 30, 2022, compared to $1.5 million during the six months
ended June 30, 2021.

The increase in operating income is primarily attributable to the revenue
recognized under the Nestlé's collaboration agreement, as we updated the
measurement of progress of the Phase II clinical trial conducted as part of the
agreement. During the six months ended June 30, 2021 negative revenue was
recognized under the Nestlé's collaboration agreement due to delays in new
patient enrollment.The decrease in research tax credit is attributable to the
decline in eligible expenses in connection with Research and Development costs.

Research and Development Expenses

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


                                                  Six Months Ended June 30,
Research and Development expenses                 2022                2021           $ change       % change
External clinical-related expenses                   19,014              22,686         (3,672 )          (16 )%
Employee-related costs                                5,114               7,297         (2,183 )          (30 )%
Share-based payment expenses                          1,058                 814            244             30 %
Depreciation, amortization and other costs            5,648              

11,546 (5,898 ) (51 )%


Total Research and Development expenses              30,834              42,343        (11,509 )          (27 )%




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

Employee-related costs, excluding share-based payments expenses, decreased by
$2.2 million for the six months ended June 30, 2022, compared to the six months
ended June 30, 2021 due to the workforce reduction following full implementation
of the new organization.

Sales and Marketing expenses

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


                                                  Six Months Ended June 30,
Sales and Marketing expenses                       2022                2021            $ change        % change
External professional services                          521                 391              130              33 %
Employee-related costs                                  539                 877             (338 )           (39 )%
Share-based payment expenses                             49                 159             (110 )           (69 )%
Depreciation, amortization and other costs              391                 500             (109 )           (22 )%

Total Sales and Marketing expenses                    1,500               1,927             (427 )           (22 )%



Sales and marketing expenses decreased by $0.4 million for the six months ended
June 30, 2022, compared to the six months ended June 30, 2021, primarily due to
a decrease in employee-related costs.

Employee-related costs, excluding share-based payments expenses, decreased by
$0.4 million for the six months ended June 30, 2022, compared to the six months
ended June 30, 2021 due to the workforce reduction following full implementation
of the new organization.

General and Administrative expenses

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


                                                  Six Months Ended June 30,
General and Administrative expenses               2022                2021           $ change       % change
External professional services                        2,879               4,210         (1,330 )          (32 )%
Employee-related costs                                4,029               5,211         (1,181 )          (23 )%
Share-based payment expenses                          1,333               1,554           (221 )          (14 )%
Depreciation, amortization and other costs            4,093               

6,977 (2,884 ) (41 )%


Total General and Administrative expenses            12,334              

17,951 (5,617 ) (31 )%




General and Administrative expenses decreased by $5.7 million for the six months
ended June 30, 2022, compared to the six months ended June 30, 2021, primarily
due to a decrease of depreciation, amortization and other costs.

The decrease in employee-related costs, excluding share-based payment expenses,
is directly related to the workforce reduction following full implementation of
the new organization
.

Financial income (expense)

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

Income tax

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

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Net loss


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

Liquidity and Capital Resources

Financial Condition


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

We may seek to finance our future cash needs through a combination of public or
private equity or debt financings, collaborations, license and development
agreements and other forms of
non-dilutive
financings. A severe or prolonged economic downturn could result in a variety of
risks to us, including reduced ability to raise additional capital when needed
or on acceptable terms, if at all.

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

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

Sources of Liquidity and Material Cash Requirements


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

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


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

In June 2022, the Company announced an aggregate $194 million PIPE financing
(corresponding to €181 million on the basis of an exchange rate of $1.0739 =
€1.00 published by the European Central Bank on June 8, 2022) from the sale of
32,855,669 Ordinary Shares, as well as
pre-funded
warrants to purchase up to 28,276,331 Ordinary Shares.

We cannot guarantee that we will be able to obtain the necessary financing to
meet our needs or to obtain funds at attractive terms and conditions, including
as a result of disruptions to the global financial markets due to the ongoing
COVID-19
pandemic. A severe or prolonged economic downturn could result in a variety of
risks to us, including reduced ability to raise additional capital when needed
or on acceptable terms, if at all.

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


                                                          Material Cash 

Requirements Due by the period Ended

                                                                               June 30,
                                                2023              2024             2025          Thereafter        Total

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

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


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

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

Conditional advances


In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV
Technologies to help finance the pharmaceutical development of Viaskin
™
Milk. This amount was received in a single disbursement on November 27, 2014. In
2020, due to the
COVID-19
pandemic, Bpifrance postponed the repayments for a
6-month
period. Repayment will end during the third quarter of 2022.

Operating leases

Our corporate headquarters are located in Montrouge, France. Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 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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