Montrouge, France, October 31, 2023
DBV Technologies Receives Requested Feedback from FDA on Protocol Design
Elements for COMFORT Safety Studies and Reports Third Quarter 2023 Financial
Results
* DBV has received written feedback from the U.S. Food and Drug Administration
(FDA) clarifying design elements for both the COMFORT Toddlers and COMFORT
Children supplemental safety studies.
* Both supplemental safety studies will have harmonized, simplified protocol
language on how the product should be used.
* The COMFORT Toddlers study will apply the same eligibility criteria as
EPITOPE, DBV's successful Phase 3 efficacy study in toddlers 1-3 years.
* DBV will submit the final protocol for COMFORT Toddlers to FDA expeditiously
and anticipates the first subject enrolled in Q1 2024.
* DBV closes Q3 2023 with a cash balance of $149 million.
* The Company will host a conference call and live audio webcast on Tuesday,
October 31(st) at 5:00pm.
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), a clinical-stage biopharmaceutical company, today announced the receipt
of written feedback from the U.S. Food and Drug Administration (FDA) regarding
the remaining study design elements for the COMFORT (Characterization of the
Optimal Management of FOod Allergy Relief and Treatment) supplemental safety
studies. The Company also reported financial results for the third quarter of
2023. The quarterly financial statements were approved by the Board of Directors
on October 31, 2023.
Recent Business Developments
Following DBV's request for clarification after receipt of Type C Meeting
feedback in July 2023, the FDA provided Written Responses on protocol design
elements for the COMFORT supplemental safety studies. Both COMFORT Toddlers and
COMFORT Children protocol will have harmonized language guiding how the product
will be used in the trials, such as, "Each DBV712 250 ?g epicutaneous system is
intended to be worn for a full day (24 hours)." These instructions are simpler
and more concise relative to previously used protocol language.
Further to this approach, both supplemental safety studies will seek to enroll
populations that are closely aligned with their respective Phase 3 efficacy
studies, as is feasible. For COMFORT Toddlers, eligibility criteria will be the
same as in EPITOPE (Phase 3 efficacy study in 1-3-year-olds) as reliance on
peanut specific-IgE and skin prick test alone does not ensure a Regulatory-level
of assurance of peanut allergy or a similar peanut allergic patient population
relative to EPITOPE. Thus, COMFORT Toddlers will include a double-blind,
placebo-controlled food challenge (DBPCFC) as part of the Inclusion criteria.
For COMFORT Children, key inclusion criteria will remain peanut specific-IgE and
skin prick test as these criteria are well established from previously conducted
DBV studies (PEPITES and REALISE), as well as from the medical literature, and
are expected to support enrollment of a similar study population relative to
VITESSE (Phase 3 efficacy study in 4-7-year-olds). Therefore, a DBPCFC will not
be required for COMFORT Children.
The size and duration of both supplemental safety studies remains unchanged from
previous communications (https://dbv-technologies.com/press_releases/dbv-
technologies-receives-feedback-from-fda-on-design-elements-for-viaskin-peanut-
safety-studies-and-reports-second-quarter-and-half-year-2023-financial-
results/). These protocol design elements ensure closer alignment between the
supplemental safety studies and their respective efficacy studies, which should
ultimately support a more robust future BLA submission package for each
indication.
"We are very pleased with the engagement and clarity of the feedback received
from the FDA," stated Pharis Mohideen, Chief Medical Officer of DBV
Technologies. "With a clear regulatory path forward, we will submit to FDA the
final protocols for the COMFORT studies. We remain confident that this work will
support a Biologics License Application (BLA) in both age groups and potentially
bring this novel, much needed therapy to a vulnerable patient population."
DBV will implement the FDA's feedback and expects to submit the final COMFORT
Toddlers protocol design to the Agency in the coming weeks. DBV anticipates the
first subject will be enrolled in Q1 2024. The initiation of COMFORT Children is
expected after the start of COMFORT Toddlers and in alignment with VITESSE
recruitment.
Financial Highlights for the Third Quarter and the Nine Months Ended September
30, 2023
The Company's interim consolidated financial statements for the nine months
ended September 30, 2023, are prepared in accordance with accounting principles
in the U.S. ("U.S. GAAP"). Unless otherwise indicated, the financial figures
presented in the Q3 Financial Highlights comply with U.S. GAAP consolidated
financial statements. The financial figures are commented for the nine months
ended September 30, 2023, under U.S. GAAP.
Cash and Cash Equivalents
+-------------------------------------------------+----------------------------+
| | U.S. GAAP |
| +----------------------------+
|(in millions of USD) |Nine months ended September |
| | 30 |
| +------+---------------------+
| | 2023 | 2022 |
+-------------------------------------------------+------+---------------------+
|Net cash & cash equivalents at the beginning of | | |
|the period |209.2 | 77.3 |
+-------------------------------------------------+------+---------------------+
|Net cash flow used in operating activities |(66.0)| (31.8) |
+-------------------------------------------------+------+---------------------+
|Net cash flow provided by / (used in) investing | | |
|activities |(0.6) | (0.1) |
+-------------------------------------------------+------+---------------------+
|Net cash flow provided by / (used in) financing | | |
|activities | 7.0 | 194.4 |
+-------------------------------------------------+------+---------------------+
|Effect of exchange rate changes on cash & cash | | |
|equivalents |(0.4) | (27.2) |
+-------------------------------------------------+------+---------------------+
|Net cash & cash equivalents at the end of the | | |
|period |149.1 | 212.7 |
+-------------------------------------------------+------+---------------------+
Cash and cash equivalents amount to $149.1 million as of September 30, 2023,
compared to $209.2 million as of December 31, 2022, which is a net decrease by
$60.1 million mainly due to the following:
(1) $66.0 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 nine months ended September 30, 2023, increased
by $34.2 million compared to the nine months ended September 30, 2022. The
Company received 24.8 million euros (corresponding to $28.1 million on the basis
of 2021 closing exchange rate) during the nine months ended September 30, 2022,
for reimbursement of 2019, 2020, and 2021 French research tax credits.
(2) $7.0 million net proceeds from the issuance and sale of new ordinary
shares in the 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 nine
months ended September 30, 2023, compared to the nine months ended September
30, 2022. The Company issued and sold new ordinary shares in the form of ADSs
for a total gross amount of $7.8 million in June 2023 compared to $15.3 million
in May 2022, and completed a private placement financing ("PIPE") amounting to a
total gross amount of $194.0 million in June 2022.
(3) $0.4 million negative 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 nine months ended September 30, 2023.
Operating Income
+----------------------+---------------------------+---------------------------+
| | U.S. GAAP | U.S. GAAP |
| +---------------------------+---------------------------+
|In millions of USD | Three months ended |Nine months ended September|
| | September 30, | 30, |
| +----+----------------------+----+----------------------+
| |2023| 2022 |2023| 2022 |
+----------------------+----+----------------------+----+----------------------+
|Research tax credits |1.2 | 1.4 |5.0 | 4.5 |
+----------------------+----+----------------------+----+----------------------+
|Other operating income|1.1 | 0.7 |1.9 | 1.7 |
+----------------------+----+----------------------+----+----------------------+
|Operating income |2.4 | 2.1 |6.9 | 6.1 |
+----------------------+----+----------------------+----+----------------------+
Operating income amounts to $6.9 million for the nine months ended September
30, 2023, compared to $6.1 million for the nine months ended September
30, 2022, which is an increase by $0.8 million due to:
(1) $0.5 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) $0.2 million increase in other operating income that consists of revenues
recognized in advance as part of the Development, Collaboration, and Licensing
Agreement ("the Agreement") with Nestlé Health Science.
On October 30(th), 2023, Nestle Health Science and the Company agreed to
terminate, as of the effective date of signature, the Development, Collaboration
and License Agreement, which set out the terms for the development of a
standardized atopy patch test tool for the diagnosis of Cow's Milk Protein
Allergy (non-IgE-mediated) in infants and children. Additionally, the parties
agreed to end the APTITUDE study conducted as part of the collaboration due to
enrollment difficulties and not as a result of any safety issues.
Operating Expenses
+------------------------+--------------------------+--------------------------+
| | U.S. GAAP | U.S. GAAP |
| +--------------------------+--------------------------+
|In millions of USD | Three months ended | Nine months ended |
| | September 30, | September 30, |
| +----+---------------------+----+---------------------+
| |2023| 2022 |2023| 2022 |
+------------------------+----+---------------------+----+---------------------+
|Research & Development |13.8| 15.1 |47.4| 45.9 |
+------------------------+----+---------------------+----+---------------------+
|Sales & Marketing |0.7 | 0.2 |1.6 | 1.7 |
+------------------------+----+---------------------+----+---------------------+
|General & Administrative|6.2 | 4.8 |22.3| 17.2 |
+------------------------+----+---------------------+----+---------------------+
|Operating expenses |20.6| 20.1 |71.4| 64.8 |
+------------------------+----+---------------------+----+---------------------+
Operating expenses amount to $71.4 million for the nine months ended September
30, 2023, compared to $64.8 million for the nine months ended September
30, 2022, which is an increase by $6.6 million mainly due to:
(1) The increase by $1.5 million in research and development expenses is
driven by clinical - related expenses mainly to support (i) the VITESSE trial
with the first patient screened in March 2023, and (ii) the new safety study for
toddlers after the FDA confirmed additional safety data is required for BLA.
(2) The increase by $5.1 million in general and administrative expenses
related to:
a. one-time costs associated with financing activities, organizational
planning, market research, and planning activities;
b. recruitments to support general and administrative activities with a nine-
month impact at end of September 2023 compared to a one or few months impact
at end of September 2022; and
c. a provision of costs to be incurred if the Montrouge office lease agreement
is not renewed at its July 2024 term expiration.
(3) Slightly offset by the decrease by $0.1 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 |
| +--------------------------+--------------------------+
| | Three months ended | Nine months ended |
| | September 30, | September 30, |
| +------+-------------------+------+-------------------+
| | 2023 | 2022 | 2023 | 2022 |
+------------------------+------+-------------------+------+-------------------+
|Net income / (loss) (in | | | | |
|millions of USD) |(16.7)| (17.3) |(61.5)| (57.0) |
+------------------------+------+-------------------+------+-------------------+
|Basic / diluted net | | | | |
|income / (loss) per | | | | |
|share (USD/share) |(0.17)| (0.18) |(0.65)| (0.79) |
+------------------------+------+-------------------+------+-------------------+
Net result for the nine months ended September 30, 2023, is a loss amounting to
$61.5 million, compared to a loss amounting to $57.0 million for the nine months
ended September 30, 2022.
On a per share basis, net loss (based on the weighted average number of shares
outstanding over the period) is $0.65 for the nine months ended September
30, 2023.
Conference Call Information
DBV will host a conference call and live audio webcast on Tuesday, October
31(st), at 5:00 p.m. ET to report third quarter 2023 financial results and
provide a business update.
Participants may access this call 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.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited)
+----------------------------------+----------------------------------------+
| | U.S. GAAP |
| In millions of USD +--------------------+-------------------+
| | September 30, 2023 | December 31, 2022 |
+----------------------------------+--------------------+-------------------+
| Assets | 189.8 | 246.5 |
+----------------------------------+--------------------+-------------------+
| of which cash & cash equivalents | 149.1 | 209.2 |
+----------------------------------+--------------------+-------------------+
| Liabilities | 45.8 | 52.1 |
+----------------------------------+--------------------+-------------------+
| Shareholders' equity | 144.0 | 194.5 |
+----------------------------------+--------------------+-------------------+
| of which net result | (61.5) | (96.3) |
+----------------------------------+--------------------+-------------------+
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
+----------------------------+------------------------+------------------------+
| | U.S. GAAP | U.S. GAAP |
| +------------------------+------------------------+
|In millions of USD | Three months ended | Nine months ended |
| | September 30, | September 30, |
| +------+-----------------+------+-----------------+
| | 2023 | 2022 | 2023 | 2022 |
+----------------------------+------+-----------------+------+-----------------+
|Revenues | 2.4 | 2.1 | 6.9 | 6.1 |
+----------------------------+------+-----------------+------+-----------------+
|Research & Development |(13.8)| (15.1) |(47.4)| (45.9) |
+----------------------------+------+-----------------+------+-----------------+
|Sales & Marketing |(0.7) | (0.2) |(1.6) | (1.7) |
+----------------------------+------+-----------------+------+-----------------+
|General & Administrative |(6.2) | (4.8) |(22.3)| (17.2) |
+----------------------------+------+-----------------+------+-----------------+
|Operating expenses |(20.6)| (20.1) |(71.4)| (64.8) |
+----------------------------+------+-----------------+------+-----------------+
|Financial income/(expenses) | 1.5 | 0.7 | 3.0 | 1.7 |
+----------------------------+------+-----------------+------+-----------------+
|Income tax | - | - | 0.0 | (0.1) |
+----------------------------+------+-----------------+------+-----------------+
|Net loss |(16.7)| (17.3) |(61.5)| (57.0) |
+----------------------------+------+-----------------+------+-----------------+
|Basic/diluted net loss per | | | | |
|share attributable to | | | | |
|shareholders |(0.17)| (0.18) |(0.65)| (0.79) |
+----------------------------+------+-----------------+------+-----------------+
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW (unaudited)
+------------------------------------------------+-----------------------------+
| | U.S. GAAP |
| +-----------------------------+
|In millions of USD | Nine months ended September |
| | 30, |
| +------+----------------------+
| | 2023 | 2022 |
+------------------------------------------------+------+----------------------+
|Net cash flows provided / (used) in operating | | |
|activities |(66.0)| (32.0) |
+------------------------------------------------+------+----------------------+
|Net cash flows provided / (used) in investing | | |
|activities |(0.6) | (0.1) |
+------------------------------------------------+------+----------------------+
|Net cash flows provided / (used) in financing | | |
|activities | 7.0 | 194.4 |
+------------------------------------------------+------+----------------------+
|Effect of exchange rate changes on cash & cash | | |
|equivalents (U.S. GAAP presentation) |(0.4) | (27.2) |
+------------------------------------------------+------+----------------------+
|Net increase / (decrease) in cash & cash | | |
|equivalents |(60.1)| 135.4 |
+------------------------------------------------+------+----------------------+
|Net cash & cash equivalents at the beginning of | | |
|the period |209.2 | 77.3 |
+------------------------------------------------+------+----------------------+
|Net cash & cash equivalents at the end of the | | |
|period |149.1 | 212.7 |
+------------------------------------------------+------+----------------------+
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, and the
ability of any of DBV's product candidates, if approved, to improve the lives of
patients with food allergies. 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, 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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