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
31st 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 μg
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.
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
(in millions of USD) |
U.S. GAAP |
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
In millions of USD |
U.S. GAAP |
U.S. GAAP |
Three months ended September 30, |
Nine months ended September 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 30th, 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
In millions of USD |
U.S. GAAP |
U.S. GAAP |
Three months ended September 30, |
Nine months ended 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:
- one-time costs associated with
financing activities, organizational planning, market research, and
planning activities;
- 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
- 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 September 30, |
Nine months ended 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 31st, 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)
In millions of USD |
U.S. GAAP |
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)
In millions of USD |
U.S. GAAP |
U.S. GAAP |
Three months ended September 30, |
Nine months ended 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)
In millions of USD |
U.S. GAAP |
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 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, 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
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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