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™ Peanut in 1 – 3-year-olds (original
square patch) and Viaskin™ 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.
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 and April 2023 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, 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 31st, 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
(in millions of USD) |
U.S. GAAP |
IFRS |
Six months ended June 30, |
Six months ended June 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
In millions of USD |
U.S. GAAP |
U.S. GAAP |
IFRS |
Three months ended June 30, |
Six months ended June 30, |
Six months ended 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
In millions of USD |
U.S. GAAP |
U.S. GAAP |
IFRS |
Three months ended June 30, |
Six months ended June 30, |
Six months ended 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 June 30, |
Six months ended June 30, |
Six months ended 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)
In millions of USD |
U.S. GAAP |
IFRS |
June 30, 2023 |
December 31, 2022 |
June 30, 2023 |
December 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)
In millions of USD |
U.S. GAAP |
U.S. GAAP |
IFRS |
Three months ended June 30, |
Six months ended June 30, |
Six months ended 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)
In millions of USD |
U.S. GAAP |
IFRS |
Six months ended June 30, |
Six months ended June 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 TechnologiesDBV
Technologies is developing Viaskin™, an investigational proprietary
technology platform with broad potential applications in
immunotherapy. Viaskin is based on epicutaneous immunotherapy, or
EPIT™, 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 StatementsThis
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
MatthewsDBV Technologies+1
857-529-2563katie.matthews@dbv-technologies.com
Media ContactAngela MarcucciDBV
Technologies+1 646-842-2393angela.marcucci@dbv-technologies.com
Viaskin and EPIT are trademarks of DBV
Technologies.
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