DBV Technologies Provides Updates on the Viaskin Peanut Program in
Children and Toddlers and Reports Second Quarter and Half-Year 2024
Financial Results
Châtillon, France, July 30, 2024
DBV Technologies Provides Updates on the
Viaskin Peanut Program in Children and Toddlers and Reports Second
Quarter and Half-Year 2024 Financial Results
- VITESSE enrollment in
peanut allergic 4-7-year-olds is on-track and recruitment is
expected to be complete by end of Q3 2024
- DBV submitted a labeling
proposal, informed by the EPITOPE efficacy data, to the Food and
Drug Administration (FDA) to address the FDA’s protocol queries
regarding patch wear-time in COMFORT Toddlers
- DBV closes Q2 2024 with a
cash balance of $66.2 million; due to cost-saving measures, the
Company’s cash runway is extended into Q1 2025
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today shared an update on the Phase 3
study, VITESSE (Viaskin Peanut
Immunotherapy Trial to
Evaluate Safety,
Simplicity and Efficacy), using
the modified Viaskin Peanut Patch, in children ages 4 – 7 years old
with peanut allergy. The Company also provided a status update on
the COMFORT (Characterization of the
Optimal Management of
FOod allergy Relief and
Treatment) Toddlers supplemental safety study in 1
– 3-year-olds with peanut allergy. DBV reported financial results
for the second quarter and the first half of 2024. The quarterly
and half-year financial statements were approved by the Board of
Directors on July 30, 2024.
Business Update
VITESSE
DBV Technologies reports that enrollment for the VITESSE Phase 3
pivotal study in children 4 - 7-year-olds with a peanut allergy
continues to be on track to screen the last subject by the end of
Q3 2024. VITESSE is a trial evaluating efficacy and safety of the
modified Viaskin® Peanut patch in approximately 600 subjects
(randomized 2:1) with 86 participating sites in US, Canada, Europe,
UK and Australia.
“We are pleased that sites in the U.S.,
Canada, Europe, Australia, and the UK are working hard to continue
screening and enrolling subjects so that we are on-track to reach
our goal of last subject into VITESSE by the end of Q3 2024,”
said Pharis Mohideen, M.D. Chief Medical Officer at DBV
Technologies. “We are seeing great momentum via our
engagements at medical conferences and through our outreach efforts
via the patient advocacy community and with study
investigators. I look forward to the completion of study
recruitment in the months to come.”
COMFORT Toddlers
DBV Technologies and the FDA have been engaged in ongoing dialogue
since May 2023 on the COMFORT Toddlers supplemental safety study in
1 – 3-year-olds with a peanut allergy. The study protocol was
submitted on November 9, 2023, with comments provided by FDA on
March 11, 2024. Since March, much of the dialogue between DBV and
FDA regarding the COMFORT Toddlers supplemental study has focused
on patch wear-time experience, including how prescribers would
advise parents and caregivers to manage day-to-day variability in
patch wear time.
In this context, DBV proposed an approach,
informed by the EPITOPE efficacy data, that focuses on the user
experience during the first 90-days of treatment. DBV submitted to
the FDA draft labeling for Section 2 – Dosing and Administration,
for a potential Viaskin Peanut Prescribing Information (PI), along
with comprehensive supportive data and analyses. Within the first
90-days of treatment (excluding the lead-in dosing period) it is
possible to identify those patients who are very likely to have a
robust clinical efficacy response based on patch wear time
experience (i.e., “Label-in” patients). The proposed PI recommends
continuation of treatment for these patients. With the same 90-day
approach, patients less likely to have a robust clinical efficacy
response, identified by their patch wear-time experience, would be
identified as “Label-out” patients. In these instances, the PI
would recommend a shared decision-making process, between the
health care provider and the parent or caregiver, to determine
whether treatment should be discontinued.
Importantly, the data shows that the “Label-in”
and “Label-out” populations have similar immunological
characteristics at baseline and have a similar safety profile while
on treatment. However, there is clearly a difference in immune
physiology (i.e., local application site sensitivity to the
allergen, peanut protein) which impacts an individual patient’s
wear time experience.
“DBV is and always has been dedicated to
families in the food allergy community—our future patients are our
top priority,” said Daniel Tasse, Chief Executive
Officer of DBV Technologies. “We have offered a robust
proposal to the FDA with the goal of expediting and finalizing a
path forward for Viaskin Peanut in 1–3-year-olds. We believe the
proposed labeling solution, which identifies patients to label-in
and label-out of treatment with the Viaskin Peanut patch, will
provide data-driven instructions to prescribers, and thus optimize
Viaskin Peanut treatment for toddlers suffering from peanut
allergy.
“On April 29th,
the FDA Office of Vaccine Research and Review stated that non-COVID
related backlogs were behind them, that the Division was caught-up,
allowing more time for interactions with sponsors. We have indeed
seen more engagement from FDA, particularly on CMC and our clinical
program. DBV looks forward to continued dialogue with FDA in
advancing a regulatory pathway for Viaskin Peanut in
1–3-year-olds.”
DBV is currently awaiting FDA’s response to the
proposed labeling approach which was submitted on June
28th.
Conference Call
DBV will host a conference call and live audio
webcast on Tuesday, July 30th, at 5:30 p.m. ET to review
its second quarter 2024 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: +1-877-346-6112
International: +1-848-280-6350
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
Ended June 30, 2024
The Company’s interim condensed consolidated
financial statements for the six months ended June 30, 2024, are
prepared in accordance with accounting principles in the U.S.
(“U.S. GAAP”).
Cash and Cash Equivalents
In millions of USD
(unaudited)
|
U.S. GAAP |
IFRS |
six months ended
June 30, |
six months ended
June 30, |
|
2024 |
2023 |
2024 |
2023 |
|
Net cash & cash equivalents at the beginning
of the period |
141.4 |
209.2 |
141.4 |
209.2 |
|
Net cash flow used in operating activities |
(69.8) |
(46.4) |
(68.7) |
(45.4) |
|
Net cash flow provided by / (used in) investing activities |
(1.4) |
(0.3) |
(1.4) |
(0.3) |
|
Net cash flow provided by / (used in) financing activities |
(0.1) |
7.8 |
(1.2) |
6.8 |
|
Effect of exchange rate changes on cash & cash equivalents |
(3.9) |
3.7 |
(3.9) |
3.7 |
|
Net cash & cash equivalents at the end of the period |
66.2 |
174.0 |
66.2 |
174.0 |
Cash and cash equivalents amounted to $66.2
million as of June 30, 2024, compared to $141.4 million as of
December 31, 2023, a net decrease by $75.2 million including $69.8
million of net cash flow used in operating activities, mainly
external clinical-related expenses notably progress on patient
enrollment in the VITESSE Phase 3 clinical trial.
The Company has incurred operating losses and
negative cash flows from operations since inception. As of July
30th, DBV’s available cash and cash equivalents are not
projected to be sufficient to support the Company’s operating plan
for at least the next 12 months. As such, there is substantial
doubt regarding its ability to continue as a going concern.
Based on its current operations, plans and
assumptions, the Company expects that its balance of cash and cash
equivalents will be sufficient to fund its operations into Q1 2025
due to the implementation of cost-savings measures.
The Company intends to seek additional capital
as it continues research and development efforts and prepares for
the launch of Viaskin Peanut, if approved.
The Company cannot guarantee that it will be able to obtain the
necessary financing to meet its needs or to obtain funds at
attractive terms and conditions, including as a result of
disruptions to the global financial markets due to any future
pandemics, epidemics or global health crises and conflict in
Ukraine or other global political or military crises. A severe or
prolonged economic downturn could result in a variety of risks to
the Company, including reduced ability to raise additional capital
when needed or on acceptable terms, if at all.
If the Company is not successful in its
financing objectives, the Company could have to scale back its
operations, notably by delaying or reducing the scope of its
research and development efforts or obtain financing through
arrangements with collaborators or others that may require the
Company to relinquish rights to its product candidates that the
Company might otherwise seek to develop or commercialize
independently.
This interim condensed financial information
does not include any adjustments to the carrying amounts and
classification of assets, liabilities, and reported expenses that
may be necessary if the Company was unable to continue as a going
concern.
Operating Income
In millions of USD
(unaudited)
|
U.S. GAAP |
U.S. GAAP |
IFRS |
|
six months
ended June 30, |
three months ended June 30, |
six months ended June 30, |
|
|
2024 |
2023 |
2024 |
2023 |
2024 |
2023 |
|
|
Research tax credits |
2.6 |
3.7 |
1.2 |
2.0 |
2.6 |
3.7 |
|
|
Other operating income |
— |
0.7 |
— |
0.3 |
— |
0.8 |
|
|
Operating income |
2.6 |
4.5 |
1.2 |
2.3 |
2.6 |
4.5 |
|
Operating income amounted to $2.6 million for
the 6 months ended June 30, 2024, compared with $4.5 million for
the same period in 2023. This decrease by $1.9 million is mostly
due to a lower Research Tax credit entitlement as a greater
proportion of studies activities are carried out in North
America.
Operating Expenses
In millions of USD
(unaudited)
|
U.S. GAAP |
U.S. GAAP |
IFRS |
|
six months ended June 30, |
three months ended June 30, |
six months ended June 30, |
|
2024 |
2023 |
2024 |
2023 |
2024 |
2023 |
|
Research & Development |
(46.8) |
(33.7) |
(25.4) |
(17.6) |
(46.7) |
(33.6) |
|
Sales & Marketing |
(1.7) |
(0.9) |
(1.0) |
(0.5) |
(1.7) |
(0.9) |
|
General & Administrative |
(16.4) |
(16.1) |
(8.6) |
(9.2) |
(16.5) |
(16.2) |
|
Operating expenses |
(65.0) |
(50.7) |
(35.0) |
(27.4) |
(64.9) |
(50.7) |
Operating expenses amounted to $65.0 million for
the six months ended June 30, 2024, compared with $50.7 million for
the six months ended June 30, 2023, an increase by $14.3 million
driven primarily by Research & Development resulting from both
patient enrollment in VITESSE Phase 3 clinical trial
and preparatory activities for the COMFORT studies in
anticipation of initiation after FDA alignment.
Employee-related costs increased overall by $3.1
million for the six months ended June 30, 2024, compared to the six
months ended June 30, 2023, as the Company expanded headcount by 24
to support clinical, regulatory and quality activities in
preparation for BLA submission.
General and Administrative expenses increased
slightly during the six months ended June 30, 2024, compared to the
six months ended June 30, 2023, due to the optimization and
rationalization of external professional services.
Net Loss and Net Loss Per Share
|
|
U.S. GAAP |
U.S. GAAP |
IFRS |
| |
six months ended June 30, |
three months ended June 30, |
six months ended June 30, |
|
|
|
2024 |
2023 |
2024 |
2023 |
2024 |
2023 |
|
|
Net income / (loss) (in millions of USD) |
(60.5) |
(44.8) |
(33.1) |
(24.2) |
(60.6) |
(44.9) |
|
|
Basic / diluted net income / (loss) per share (USD/share) |
(0.63) |
(0.48) |
(0.34) |
(0.26) |
(0.63) |
(0.48) |
|
The Company recorded a net loss for the first
six months ended June 30, 2024, of $60.5 million, compared to a net
loss of $44.8 million for the first six months ended June 30,
2023.
On a per share basis, net loss (based on the
weighted average number of shares outstanding over the period) was
$(0.63) for the first six months ended June 30, 2024.
CONDENSED CONSOLIDATED STATEMENTS OF
FINANCIAL POSITION
(unaudited)
In millions of USD
|
U.S. GAAP |
IFRS |
June 30,
2024 |
December 31, 2023 |
June 30,
2024 |
December 31, 2023 |
|
Assets |
114.2 |
183.0 |
114.2 |
183.0 |
|
of which cash & cash equivalents |
66.2 |
141.4 |
66.2 |
141.4 |
|
Liabilities |
35.1 |
42.8 |
35.0 |
42.7 |
|
Shareholders’ equity |
79.1 |
140.2 |
79.2 |
140.3 |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited)
In millions of USD
|
U.S. GAAP |
U.S. GAAP |
IFRS |
|
six months ended June 30, |
three months ended June 30, |
six months ended June 30,
three months ended June 30, |
|
2024 |
2023 |
2024 |
2023 |
2024 |
2023 |
|
Revenues |
2.6 |
4.5 |
1.2 |
2.3 |
2.6 |
4.5 |
|
Research & Development |
(46.8) |
(33.7) |
(25.4) |
(17.6) |
(46.7) |
(33.6) |
|
Sales & Marketing |
(1.7) |
(0.9) |
(1.0) |
(0.5) |
(1.7) |
(0.9) |
|
General & Administrative |
(16.4) |
(16.1) |
(8.6) |
(9.2) |
(16.5) |
(16.2) |
|
Operating expenses |
(65.0) |
(50.7) |
(35.0) |
(27.4) |
(64.9) |
(50.7) |
|
Financial income/(expenses) |
2.0 |
1.5 |
0.7 |
0.8 |
1.8 |
1.4 |
|
Income tax |
— |
— |
— |
— |
— |
— |
|
Net loss |
(60.5) |
(44.8) |
(33.1) |
(24.2) |
(60.6) |
(44.9) |
|
Basic/diluted net loss per share attributable
to shareholders |
(0.63) |
(0.48) |
(0.34) |
(0.26) |
(0.63) |
(0.48) |
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS (unaudited)
In millions of USD
|
U.S. GAAP |
IFRS |
six months ended
June 30, |
six months ended
June 30, |
|
2024 |
2023 |
2024 |
2023 |
|
Net cash flows provided / (used) in operating activities |
(69.8) |
(46.4) |
(68.7) |
(45.4) |
|
Net cash flows provided / (used) in investing activities |
(1.4) |
(0.3) |
(1.4) |
(0.3) |
|
Net cash flows provided / (used) in financing activities |
(0.1) |
7.8 |
(1.2) |
6.8 |
|
Effect of exchange rate changes on cash & cash equivalents
(U.S. GAAP presentation) |
(3.9) |
3.7 |
(3.9) |
3.7 |
|
Net increase / (decrease) in cash & cash equivalents |
(75.2) |
(35.2) |
(71.3) |
(38.9) |
|
Net cash & cash equivalents at the beginning of the period |
141.4 |
209.2 |
141.4 |
209.2 |
|
Net cash & cash equivalents at the end of the period |
66.2 |
174.0 |
66.2 |
174.0 |
About DBV Technologies
DBV Technologies is a clinical-stage biopharmaceutical company
developing treatment options for food allergies and other
immunologic conditions with significant unmet medical need. DBV is
currently focused on investigating the use of its proprietary
technology platform, Viaskin, to address food allergies, which are
caused by a hypersensitive immune reaction and characterized by a
range of symptoms varying in severity from mild to life-threatening
anaphylaxis. Millions of people live with food allergies, including
young children. Through epicutaneous immunotherapy (EPIT™), the
Viaskin platform is designed to introduce microgram amounts of a
biologically active compound to the immune system through intact
skin. EPIT is a new class of non-invasive treatment that seeks to
modify an individual’s underlying allergy by re-educating the
immune system to become desensitized to allergen by leveraging the
skin’s immune tolerizing properties. DBV is committed to
transforming the care of food allergic people. The Company’s food
allergy programs include ongoing clinical trials of Viaskin Peanut
in peanut allergic toddlers (1 through 3 years of age) and children
(4 through 7 years of age).
DBV Technologies is headquartered in Châtillon,
France, with North American operations in Warren, 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 ordinary share) are traded on the Nasdaq Capital
Select Market (Ticker: DBVT).
For more information, please visit
www.dbv-technologies.com and engage with us on X (formerly Twitter)
and LinkedIn.
Forward Looking Statements
This press release may contain forward-looking statements and
estimates, including statements regarding DBV’s financial
condition, forecast of its cash runway, the therapeutic potential
of Viaskin® Peanut patch and EPIT™, 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.
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, 2023, filed with the SEC on March 7, 2024, 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.
Viaskin is a registered trademark and EPIT is a
trademark of DBV Technologies.
Investor Contact
Katie Matthews
DBV Technologies
katie.matthews@dbv-technologies.com
Media Contact
Angela Marcucci
DBV Technologies
angela.marcucci@dbv-technologies.com
DBV Technologies (TG:DBV)
Historical Stock Chart
From Dec 2024 to Jan 2025
DBV Technologies (TG:DBV)
Historical Stock Chart
From Jan 2024 to Jan 2025
