Montrouge, France, July 31, 2023
DBV Technologies Receives Feedback from FDA on Design Elements for Viaskin
Peanut Safety Studies and Reports Second Quarter and Half-Year 2023 Financial
Results
* Received feedback from U.S. Food and Drug Administration (FDA) on DBV's two
supplemental safety studies in toddlers (ages 1 - 3 years) and children
(ages 4 - 7 years).
* The two Phase 3 pivotal safety studies will be named COMFORT Toddlers (1 -
3 years) and COMFORT Children (4 - 7 years).
* COMFORT Toddlers will be a 6-month safety study, consistent with agreement
previously reached with FDA on the COMFORT Children safety study.
* The Company expects to seek final alignment with FDA on the COMFORT
protocols prior to commencing the studies.
* DBV closes Q2 2023 with a cash balance of $174 million.
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), a clinical-stage biopharmaceutical company, today announced the receipt
of Written Responses from the FDA on key study design elements for the COMFORT
(Characterization of the Optimal Management of FOod Allergy Relief and
Treatment) Toddlers and COMFORT Children supplemental safety studies in 1 - 3-
year-olds and 4 - 7-year-olds, respectively, with a peanut allergy. The Company
also reported financial results for the second quarter and the first half of
2023. The quarterly and half-year financial statements were approved by the
Board of Directors on July 28, 2023.
Recent Business Developments
Viaskin(TM) Peanut in 1 - 3-year-olds (original square patch) and Viaskin(TM) Peanut
in 4 - 7-year-olds (modified circular patch) are separate product candidates
with independent clinical and regulatory paths supporting two distinct Biologics
License Applications (BLAs).
DBV received Type C Meeting Written Responses from the FDA on the two
supplemental safety studies, known as COMFORT. The COMFORT Toddlers safety study
will enroll peanut allergic toddlers ages 1 - 3-years and will support the
efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT
Children safety study will enroll peanut allergic children ages 4 - 7-years and
will support the efficacy results anticipated from the ongoing VITESSE Phase 3
pivotal study.
The FDA agreed with a 6-month study duration and a 3:1 randomization
(active:placebo) of approximately 400 subjects in the double-blind, placebo-
controlled COMFORT Toddlers study. Both COMFORT studies will assess adhesion
using the same tools and measurements that were established in VITESSE. Neither
the COMFORT Toddlers study nor the COMFORT Children study will require an oral
food challenge for participation.
The feedback received is consistent with FDA's position on COMFORT Children in
4 - 7-year-olds, as previously announced in December 2022 (https://dbv-
technologies.com/wp-content/uploads/ir/press-release_vitesse-pch-
lift_12.23.2022_en-final.pdf).
Both COMFORT studies aim to bring the total number of subjects on active
treatment to approximately 600 participants in each age group, when added to
their respective Phase 3 pivotal efficacy studies (i.e., EPITOPE and VITESSE).
"We are pleased to have received feedback from the FDA on key design elements
for the COMFORT safety study protocols in 1 - 3 and 4 - 7-year-olds with peanut
allergy," said Daniel Tassé, Chief Executive Officer, DBV Technologies. "This
continues the positive momentum DBV received in December 2022 (https://dbv-
technologies.com/wp-content/uploads/ir/press-release_vitesse-pch-
lift_12.23.2022_en-final.pdf) and April 2023 (https://dbv-
technologies.com/press_releases/dbv-technologies-outlines-regulatory-path-for-
viaskin-peanut-in-children-1-3-years-after-receiving-pre-bla-responses-from-
fda/) when we outlined our regulatory pathways for Viaskin Peanut in children
and toddlers. We are actively enrolling subjects in the VITESSE Phase 3 study
and were also honored to have our EPITOPE data published in the New England
Journal of Medicine in May (https://dbv-technologies.com/press_releases/dbv-
technologies-announces-new-england-journal-of-medicine-publication-of-phase-3-
epitope-trial-data-evaluating-viaskin-peanut-in-toddlers/), with an accompanying
editorial. The COMFORT Toddlers and COMFORT Children safety studies meet the
FDA's request for additional safety studies in these patient populations. As we
complete the final protocols, which we expect to share with FDA, we are
actively progressing site selection and contracting to enable the start of the
COMFORT safety studies as soon as final FDA protocol alignment is achieved."
Conference Call
DBV will host a conference call and live audio webcast on Monday, July 31(st),
at 5:00 p.m. ET to report first half 2023 financial results and provide a
corporate update.
Participants may access this event via the below teleconferencing numbers and
asking to join the DBV Technologies call:
* United States: 1-844-481-2866
* International: +1-412-317-1859
A live webcast of the call will be available on the Investors & Media section of
the Company's website: https://www.dbv-technologies.com/investor-relations/. A
replay of the presentation will also be available on DBV's website after the
event.
Financial Highlights for the Second Quarter and the Six Months Ended June
30, 2023
The Company's interim consolidated financial statements for the six months ended
June 30, 2023, are prepared in accordance with both generally accepted
accounting principles in the U.S. ("U.S. GAAP") and International Financial
Reporting Standards ("IFRS") as adopted by the European Union. Unless otherwise
indicated, the financial figures presented in the Q2 Financial Highlights comply
with both U.S. GAAP and IFRS consolidated financial statements. The financial
figures are commented for the six months ended June 30, 2023, under U.S. GAAP.
Differences between U.S. GAAP and IFRS consolidated financial statements are
mainly due to discrepancies arising from the application of lease accounting
standards.
Cash and Cash Equivalents
+------------------------------+-----------------------+-----------------------+
| | U.S. GAAP | IFRS |
| +-----------------------+-----------------------+
|(in millions of USD) | Six months ended June | Six months ended June |
| | 30, | 30, |
| +------+----------------+------+----------------+
| | 2023 | 2022 | 2023 | 2022 |
+------------------------------+------+----------------+------+----------------+
|Net cash & cash equivalents at| | | | |
|the beginning of the period |209.2 | 77.3 |209.2 | 77.3 |
+------------------------------+------+----------------+------+----------------+
|Net cash flow used in | | | | |
|operating activities |(46.4)| (11.7) |(45.4)| (8.6) |
+------------------------------+------+----------------+------+----------------+
|Net cash flow provided by / | | | | |
|(used in) investing activities|(0.3) | (0.2) |(0.3) | (0.2) |
+------------------------------+------+----------------+------+----------------+
|Net cash flow provided by / | | | | |
|((used in) financing | | | | |
|activities | 7.8 | 195.2 | 6.8 | 192.1 |
+------------------------------+------+----------------+------+----------------+
|Effect of exchange rate | | | | |
|changes on cash & cash | | | | |
|equivalents | 3.7 | (12.6) | 3.7 | (12.6) |
+------------------------------+------+----------------+------+----------------+
|Net cash & cash equivalents at| | | | |
|the end of the period |174.0 | 248.0 |174.0 | 248.0 |
+------------------------------+------+----------------+------+----------------+
Cash and cash equivalents amount to $174.0 million as of June 30, 2023, compared
to $209.2 million as of December 31, 2022, which is a net decrease by $35.2
million mainly due to the following:
(1) $46.4 million of cash used for operations, mainly driven by the initiation
of the VITESSE trial with the first patient screened in March 2023.
Cash used for operations in the six months ended June 30, 2023, increased by
$34.7 million compared to the six months ended June 30, 2022. The Company
received 24.8 million euros during the six months ended June 30, 2022, for
reimbursement of 2019, 2020, and 2021 French research tax credits.
(2) $7.8 million proceeds from the issuance and sale of new ordinary shares in
form of American Depositary Shares ("ADSs") on June 16, 2023, and pursuant to
the At-The-Market ("ATM") program established in May 2022.
Cash provided by financing activities decreased by $187.4 million in the six
months ended June 30, 2023, compared to the six months ended June 30, 2022. The
Company issued and sold new ordinary shares in form of ADSs for a total gross
amount of $15.3 million in May 2022, and completed a private placement financing
("PIPE") amounting to $194.0 million gross in June 2022.
(3) $3.7 million positive impact of changes in exchange rates. The Company's
treasury position, stated in U.S. Dollars, has been impacted by an appreciation
of Euro against U.S. Dollar during the six months ended June 30, 2023.
Operating Income
+-------------------+-------------------+-------------------+------------------+
| | U.S. GAAP | U.S. GAAP | IFRS |
| +-------------------+-------------------+------------------+
|In millions of USD |Three months ended | Six months ended | Six months ended |
| | June 30, | June 30, | June 30, |
| +----+--------------+----+--------------+----+-------------+
| |2023| 2022 |2023| 2022 |2023| 2022 |
+-------------------+----+--------------+----+--------------+----+-------------+
|Research tax | | | | | | |
|credits |2.0 | 1.5 |3.7 | 3.1 |3.7 | 3.1 |
+-------------------+----+--------------+----+--------------+----+-------------+
|Other operating | | | | | | |
|income |0.3 | - |0.7 | 1.0 |0.7 | 1.0 |
+-------------------+----+--------------+----+--------------+----+-------------+
|Operating income |2.3 | 1.5 |4.4 | 4.1 |4.4 | 4.1 |
+-------------------+----+--------------+----+--------------+----+-------------+
Operating income amounts to $4.4 million for the six months ended June
30, 2023, compared to $4.1 million for the six months ended June 30, 2022, which
is an increase by $0.3 million due to:
(1) $0.6 million increase in research tax credit estimate as costs eligible to
the French tax credit increased to support research and development activities
(a) after the initiation of VITESSE with the first patient screened in March
2023, and (b) as part of the new safety study for toddlers after the FDA
confirmed in April 2023 additional safety data is required for BLA submission.
(2) Partially offset by a decrease by $0.3 million in other operating income
that consists of revenues recognized in advance as part of the collaboration
agreement with Nestlé Health Science ("NHS").
Operating Expenses
+-----------------------+------------------+-----------------+-----------------+
| | U.S. GAAP | U.S. GAAP | IFRS |
| +------------------+-----------------+-----------------+
|In millions of USD |Three months ended|Six months ended |Six months ended |
| | June 30, | June 30, | June 30, |
| +----+-------------+----+------------+----+------------+
| |2023| 2022 |2023| 2022 |2023| 2022 |
+-----------------------+----+-------------+----+------------+----+------------+
|Research & Development |17.6| 18.6 |33.6| 30.8 |33.5| 30.7 |
+-----------------------+----+-------------+----+------------+----+------------+
|Sales & Marketing |0.5 | 1.0 |1.0 | 1.5 |1.0 | 1.5 |
+-----------------------+----+-------------+----+------------+----+------------+
|General & | | | | | | |
|Administrative |9.2 | 5.7 |16.1| 12.3 |16.2| 12.2 |
+-----------------------+----+-------------+----+------------+----+------------+
|Operating expenses |27.3| 25.3 |50.7| 44.6 |50.7| 44.4 |
+-----------------------+----+-------------+----+------------+----+------------+
Operating expenses amount to $50.7 million for the six months ended June
30, 2023, compared to $44.6 million for the six months ended June 30, 2022,
which is an increase by $6.1 million mainly due to:
(1) The increase by $2.8 million in research and development expenses mainly
explained by the difference in phasing of on-going clinical trials between the
two compared periods, including initiation costs of the VITESSE trial with the
first patient screened in March 2023.
(2) The increase by $3.8 million in general and administrative expenses mainly
related to one-time costs associated with financing activities, organizational
planning, market research and planning activities.
(3) Partially offset by the decrease by $0.5 million in sales and marketing
expenses due to a decrease of external professional services and employee-
related costs.
Net Loss and Net Loss Per Share
+------------------+-------------------+-------------------+-------------------+
| | U.S. GAAP | U.S. GAAP | IFRS |
| +-------------------+-------------------+-------------------+
| |Three months ended | Six months ended | Six months ended |
| | June 30, | June 30, | June 30, |
| +------+------------+------+------------+------+------------+
| | 2023 | 2022 | 2023 | 2022 | 2023 | 2022 |
+------------------+------+------------+------+------------+------+------------+
|Net income / | | | | | | |
|(loss) (in | | | | | | |
|millions of USD) |(24.2)| (23.0) |(44,8)| (39.7) |(44.9)| (39.5) |
+------------------+------+------------+------+------------+------+------------+
|Basic / diluted | | | | | | |
|net income / | | | | | | |
|(loss) per share | | | | | | |
|(USD/share) |(0.26)| (0.35) |(0.48)| (0.66) |(0.48)| (0.65) |
+------------------+------+------------+------+------------+------+------------+
Net result for the six months ended June 30, 2023, is a loss amounting to $44.8
million, compared to a loss amounting to $39.7 million for the six months ended
June 30, 2022.
On a per share basis, net loss (based on the weighted average number of shares
outstanding over the period) is $0.48 for the six months ended June 30, 2023.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited)
+--------------------+----------------------------+----------------------------+
| | U.S. GAAP | IFRS |
| +-------------+--------------+-------------+--------------+
| In millions of USD | | December | | December |
| |June 30, 2023| 31, 2022 |June 30, 2023| 31, 2022 |
+--------------------+-------------+--------------+-------------+--------------+
|Assets | 217.5 | 246.5 | 217.5 | 246.5 |
+--------------------+-------------+--------------+-------------+--------------+
|of which cash & cash| | | | |
|equivalents | 174.0 | 209.2 | 174.0 | 209.2 |
+--------------------+-------------+--------------+-------------+--------------+
|Liabilities | 53.3 | 52.0 | 53.2 | 52.0 |
+--------------------+-------------+--------------+-------------+--------------+
|Shareholders' equity| 164.2 | 194.5 | 164.3 | 194.5 |
+--------------------+-------------+--------------+-------------+--------------+
|of which net result | (44.8) | (96.2) | (44.9) | (96.0) |
+--------------------+-------------+--------------+-------------+--------------+
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
+----------------------+------------------+------------------+-----------------+
| | U.S. GAAP | U.S. GAAP | IFRS |
| +------------------+------------------+-----------------+
|In millions of USD |Three months ended| Six months ended |Six months ended |
| | June 30, | June 30, | June 30, |
| +------+-----------+------+-----------+------+----------+
| | 2023 | 2022 | 2023 | 2022 | 2023 | 2022 |
+----------------------+------+-----------+------+-----------+------+----------+
|Revenues | 2.3 | 1.5 | 4.5 | 4.1 | 4.5 | 4.1 |
+----------------------+------+-----------+------+-----------+------+----------+
|Research & Development|(17.6)| (18.6) |(33.6)| (30.8) |(33.5)| (30.7) |
+----------------------+------+-----------+------+-----------+------+----------+
|Sales & Marketing |(0.5) | (1.0) |(1.0) | (1.5) |(1.0) | (1.5) |
+----------------------+------+-----------+------+-----------+------+----------+
|General & | | | | | | |
|Administrative |(9.2) | (5.7) |(16.1)| (12.3) |(16.2)| (12.2) |
+----------------------+------+-----------+------+-----------+------+----------+
|Operating expenses |(27.3)| (25.3) |(50.7)| (44.6) |(50.7)| (44.3) |
+----------------------+------+-----------+------+-----------+------+----------+
|Financial | | | | | | |
|income/(expenses) | 0.8 | 0.8 | 1.4 | 0.9 | 1.4 | 0.8 |
+----------------------+------+-----------+------+-----------+------+----------+
|Income tax | - | - | - | - | - | - |
+----------------------+------+-----------+------+-----------+------+----------+
|Net loss |(24.2)| (23.0) |(44.8)| (39.6) |(44.9)| (39.5) |
+----------------------+------+-----------+------+-----------+------+----------+
|Basic/diluted net loss| | | | | | |
|per share attributable| | | | | | |
|to shareholders |(0.26)| (0.35) |(0.48)| (0.66) |(0.48)| (0.65) |
+----------------------+------+-----------+------+-----------+------+----------+
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW (unaudited)
+------------------------------+-----------------------+-----------------------+
| | U.S. GAAP | IFRS |
| +-----------------------+-----------------------+
|In millions of USD | Six months ended June | Six months ended June |
| | 30, | 30, |
| +------+----------------+------+----------------+
| | 2023 | 2022 | 2023 | 2022 |
+------------------------------+------+----------------+------+----------------+
|Net cash flows provided / | | | | |
|(used) in operating activities|(46.4)| (11.7) |(45.4)| (8.6) |
+------------------------------+------+----------------+------+----------------+
|Net cash flows provided / | | | | |
|(used) in investing activities|(0.3) | (0.2) |(0.3) | (0.2) |
+------------------------------+------+----------------+------+----------------+
|Net cash flows provided / | | | | |
|(used) in financing activities| 7.8 | 195.2 | 6.8 | 192.1 |
+------------------------------+------+----------------+------+----------------+
|Effect of exchange rate | | | | |
|changes on cash & cash | | | | |
|equivalents (U.S. GAAP | | | | |
|presentation) | 3.7 | (12.6) | | |
+------------------------------+------+----------------+------+----------------+
|Net increase / (decrease) in | | | | |
|cash & cash equivalents |(35.2)| 170.7 |(38.9)| 183.3 |
+------------------------------+------+----------------+------+----------------+
|Net cash & cash equivalents at| | | | |
|the beginning of the period |209.2 | 77.3 |209.2 | 77.3 |
+------------------------------+------+----------------+------+----------------+
|Effect of exchange rate | | | | |
|changes on cash & cash | | | | |
|equivalents (IFRS | | | | |
|presentation) | | | 3.7 | (12.6) |
+------------------------------+------+----------------+------+----------------+
|Net cash & cash equivalents at| | | | |
|the end of the period |174.0 | 248.0 |174.0 | 248.0 |
+------------------------------+------+----------------+------+----------------+
About DBV Technologies
DBV Technologies is developing Viaskin(TM), an investigational proprietary
technology platform with broad potential applications in immunotherapy. Viaskin
is based on epicutaneous immunotherapy, or EPIT(TM), and is DBV Technologies'
method of delivering biologically active compounds to the immune system through
intact skin. With this new class of non-invasive product candidates, the Company
is dedicated to safely transforming the care of food allergic patients. DBV
Technologies' food allergies programs include ongoing clinical trials of Viaskin
Peanut. DBV Technologies has global headquarters in Montrouge, France, and North
American operations in Basking Ridge, NJ. The Company's ordinary shares are
traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and
the Company's ADSs (each representing one-half of one ordinary share) are traded
on the Nasdaq Global Select Market (Ticker: DBVT).
Forward Looking Statements
This press release may contain forward-looking statements and estimates,
including statements regarding DBV's forecast of its cash runway, designs of
DBV's anticipated clinical trials, DBV's planned regulatory and clinical efforts
including timing and results of communications with regulatory agencies, the
ability of any of DBV's product candidates, if approved, to improve the lives of
patients with food allergies, and the outcome of any litigation. These forward-
looking statements and estimates are not promises or guarantees and involve
substantial risks and uncertainties. At this stage, DBV's product candidates
have not been authorized for sale in any country. Among the factors that could
cause actual results to differ materially from those described or projected
herein include uncertainties associated generally with research and development,
clinical trials and related regulatory reviews and approvals, including the
impact of the COVID-19 pandemic, and DBV's ability to successfully execute on
its budget discipline measures. A further list and description of risks and
uncertainties that could cause actual results to differ materially from those
set forth in the forward-looking statements in this press release can be found
in DBV's regulatory filings with the French Autorité des Marchés Financiers
("AMF"), DBV's filings and reports with the U.S. Securities and Exchange
Commission ("SEC"), including in DBV's Annual Report on Form 10-K for the year
ended December 31, 2022, filed with the SEC on March 2, 2023, and future filings
and reports made with the AMF and SEC by DBV. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking statements
and estimates, which speak only as of the date hereof. Other than as required by
applicable law, DBV Technologies undertakes no obligation to update or revise
the information contained in this Press Release.
Investor Contact
Katie Matthews
DBV Technologies
+1 857-529-2563
katie.matthews@dbv-technologies.com (mailto:katie.matthews@dbv-technologies.com)
Media Contact
Angela Marcucci
DBV Technologies
+1 646-842-2393
angela.marcucci@dbv-technologies.com (mailto:angela.marcucci@dbv-
technologies.com)
Viaskin and EPIT are trademarks of DBV Technologies.
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