Form 8-K - Current report
2025年1月9日 - 7:30AM
Edgar (US Regulatory)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
January 8, 2025
Date of Report (Date of earliest event reported)
DBV Technologies S.A.
(Exact name of registrant as specified in its charter)
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France |
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001-36697 |
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Not applicable |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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107 avenue de la République 92320 Châtillon France |
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Not Applicable |
(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: +33 1 55 42 78 78
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Ordinary shares, nominal value €0.10 per share |
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n/a |
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The Nasdaq Stock Market LLC * |
American Depositary Shares, each representing five ordinary shares, nominal value €0.10 per share |
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DBVT |
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The Nasdaq Stock Market LLC |
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Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC. |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. |
Regulation FD Disclosure |
On January 8, 2025, the Company issued a press release entitled “DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study.” The full text of the Press Release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The information contained in Item 7.01 in this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: January 8, 2025 |
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DBV TECHNOLOGIES S.A. |
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By: |
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/s/ Virginie Boucinha |
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Name: |
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Virginie Boucinha |
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Title: |
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Chief Financial Officer |
Exhibit 99.1
DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3
Open-Label Extension Study
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EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 3 years through 36 months |
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68.2% of subjects completed the oral food challenge (~12-14 peanut
kernels) without meeting stopping criteria, compared to 30.7% at month 12 |
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No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred
in year three of EPITOPE OLE |
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DBV also announced daily patch wear time data from EPITOPE that is supportive of the Companys proposed
labeling approach shared with FDA |
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DBV to highlight these data in multiple abstract presentations at the Eastern Food Allergy & Comorbidity
Conference, January 9-12, in Palm Beach, Florida |
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Company to host investor webcast today at 5:00pm ET |
DBV Technologies (Euronext: DBV ISIN: FR0010417345 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced
positive twenty-four month results from its Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of VIASKIN® peanut 250 µg [VP250] in toddlers ages 1 to 3 years). The data provide
support that continued treatment with VIASKIN Peanut showed further improvement through 36 months of treatment across all efficacy parameters.
DBV also
announced today new Viaskin Peanut Patch efficacy and safety data based on average daily wear time from the EPITOPE study that is supportive of the Companys VIASKIN peanut labeling strategy, proposed to FDA in June 2024. This post-hoc analysis identified subjects on Viaskin Peanut with low or high day-to-day variability in daily wear time during the first 90
days on treatment a highly predictive marker of the average daily wear time (ADWT) during the course of the 12-month study. Subjects with low day-to-day variability in daily wear time had higher ADWT which correlated with a more robust efficacy response at 12 months.
These data are being presented in multiple poster presentations at the Eastern Food Allergy &
Comorbidity Conference, which is being held January 9th through 12th, 2025, in Palm Beach, Florida.
Twenty-Four Month EPITOPE OLE Results
After completing
participation (12 months) in the EPITOPE study, eligible subjects could enroll in the OLE to receive a total of 36 months of VIASKIN peanut treatment. Double-blind placebo-controlled food challenges (DBPCFC) were conducted at the end of each
year of treatment with safety assessed throughout the entire OLE. Importantly, all subjects remained blinded to their treatment assignment in EPITOPE until every patient completed EPITOPE and the database was locked; therefore, the decision to enter
the OLE was not biased by the unblinding of the randomized treatment.
In the EPITOPE OLE, VIASKIN Peanut data suggests further improvement through 36
months of treatment across all efficacy parameters. Key data highlights include:
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266 EPITOPE participants enrolled in the OLE; 211 underwent the Month 36 DBPCFC (n=149 VP250; n=62 placebo).
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After three years of VP250, 83.5% of participants reached an eliciting dose (ED) of ≥1000 mg, an increase
from 64.2% at month 12 (the EPITOPE study). |
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A similar increase was observed for participants reaching an ED of ≥2000 mg (72.7% at month 36; 37.0% at
month 12;). |
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Those completing the DBPCFC without meeting stopping criteria increased to 68.2% at month 36 from 30.7% at month
12. |
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Continued reductions in DBPCFC reaction severity occurred, with 66.5% having no/mild symptoms at month 36 vs
40.2% at month 12. |
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No treatment-related anaphylaxis or serious treatment-related TEAEs occurred in Year 3. |
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Local application-site reactions occurred less frequently in Year 3 vs Years 1 and 2. |
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In placebo-treated EPITOPE participants, outcomes after 24 months of VP250 in the OLE were consistent with 24-month results in EPITOPE VP250 participants. |
The compelling results from 36 months of
Viaskin Peanut treatment demonstrate a continuation of the very positive efficacy and safety trends that have been previously observed in this study, said Pharis Mohideen, Chief Medical Officer, DBV Technologies. Notably,
the data indicates that continued treatment with VIASKIN Peanut resulted in further improvement across all efficacy parameters in the second year of the OLE with no new safety signals. The data show that more than
two-thirds of subjects completed the food challenge without meeting pre-defined stopping criteria, consuming the equivalent of
12-14 peanut kernels, and more than 83% reached an ED of ≥1,000mg, or the equivalent of 3-4 peanut kernels. Recall that this is a patient population
that can experience devastating consequences from accidental exposure to just fractions of a peanut kernel. As we prepare to initiate the COMFORT Toddlers supplemental safety study, one of the final steps to support a BLA submission, these results
remind us of the tremendous potential of VIASKIN Peanut as a game changer for the peanut allergy community.
Shared decision making for best
response based on patch wear experience.
DBV also announced today new data from the Phase 3 EPITOPE study that supports the labeling approach that was
proposed to FDA in June 2024. Patch wear time assessed daily by caregivers was averaged (i.e., average daily wear time or ADWT) for each subject for the first 90 days of treatment (excluding treatment initiation Days 1-28) and over the 12-month EPITOPE study.
Baseline markers of atopic disease
severity such as peanut-specific IgE, skin prick test wheal size, SCORAD scores (measure of atopic dermatitis) and eliciting dose were similar between subjects with ADWT ≥ 20 hours/day and < 20 hours/day. The incidence rates and severity of
local application site reactions and use of corticosteroids were also similar between groups, but the participants with ADWT < 20 hours reported markedly more scratching as a reason for patch detachments. This strongly suggests that these
participants experienced lower tolerability (i.e., higher degree of itchiness) to peanut-induced local skin immune responses.
Data suggests that subjects with low
day-to-day wear time variability (≥ 20 hours/day ADWT) had a more robust efficacy response relative to the high day-to-day variability (<20 hour/day ADWT) subjects.
Efficacy and safety data were compared for VP250
participants according to ADWT.
Key data highlights include:
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167/244 (68.4%) VP250 participants had an ADWT ≥20 hours, with median ADWT (22.9 hours) similar to placebo
(23.7 hours). |
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77/244 (31.6%) participants had an ADWT <20 hours (median: 16.7 hours). |
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ADWT during the first 90 days on treatment was highly predictive of ADWT over the
12-month treatment period (r=0.81). |
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Participants with ADWT ≥20 vs <20 hours during the first 90 days showed greater month 12 efficacy,
according to EPITOPE responder criteria (75.7% vs 47.3%). |
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Rates of key safety outcomes of interest were numerically lower in participants with ADWT ≥20 vs <20
hours, based on treatment-related: epinephrine use (0.6% vs 2.6%), anaphylaxis (0.6% vs 3.9%), and permanent discontinuations (9.6% vs 19.5%). |
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As a point of reference, overall clinical response in EPITOPE was 67.0% for patients on active, and 33.5% for
patients on placebo. |
Average daily wear time is something that can easily be reported by my caregivers and patients and can be
a very useful tool for me to guide shared decision making. Knowing that the ADWT during the first 90 days on treatment is highly predictive of ADWT over a full year and that these data further suggest that ADWT greater than 20 hours show a strong
correlation with clinical efficacy response at 12 months will help to guide optimal use of VIASKIN peanut, if approved., stated Dr. Edwin Kim, Division Chief, Pediatric Allergy & Immunology, University of North Carolina
School of Medicine, and presenting author.
Eastern Food Allergy and Comorbidity Conference - Poster Presentations
January 9-12, 2025, Palm Beach, FL
All posters will be displayed from 3:00pm ET on Thursday, January 9th through 11:45am ET on Saturday,
January 11th.
EPOPEX, Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-allergic
Toddlers: Results After 3 Years of Treatment
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Presenter: Matthew Greenhawt, MD |
VP250 Average Daily Wear Time: Impact on Efficacy and Safety in the Phase 3 EPITOPE Study
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Presenter: Edwin H. Kim, MD |
Changes in Biomarkers During Epicutaneous Immunotherapy for Peanut Allergy in Toddlers
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Presenter: Edwin H. Kim, MD |
We are very pleased with the progress that DBV continues to make advancing this novel therapy through its remaining regulatory steps, and believe
that, if approved, it has the potential to revolutionize the treatment of peanut allergy, stated Eleanor Garrow-Holding, CEO, Food Allergy and Anaphylaxis Connection Team. It is encouraging to see new data that further
inform the real-world use of VIASKIN Peanut, and we are hopeful that it will soon be an available treatment option for peanut allergic patients and their caregivers.
Investor Conference Call and Webcast
DBV management will
host an investor conference call and webcast today, January 8th, at 5:00pm EST, to discuss these clinical updates. This call is accessible via the below teleconferencing numbers and requesting the
DBV Technologies call.
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United States:
+1-877-346-6112 |
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International:
+1-848-280-6350 |
A live webcast of the call will be available on the Investors & Media section of the Companys
website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBVs website after the event.
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 VIASKIN® patch technology 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® patch 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 individuals underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging
the skins immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Companys 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 Companys ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Companys ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker:
DBVT; CUSIP: 23306J309).
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 the therapeutic potential of VIASKIN® Peanut patch and EPIT, designs of DBVs anticipated clinical trials, DBVs planned regulatory and clinical efforts including
timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the
confirmatory study, plans and expectations with respect to COMFORT Toddlers and COMFORT Children, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the
BLA submission, DBVs expectations with respect to the Accelerated Approval pathway and any other actionable regulatory pathway, and the ability of any of DBVs 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, DBVs 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
DBVs 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 DBVs regulatory filings with the French Autorité des Marchés Financiers (AMF), DBVs filings and reports with the U.S. Securities and Exchange Commission (SEC),
including in DBVs 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
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DBV Technologies (NASDAQ:DBVT)
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DBV Technologies (NASDAQ:DBVT)
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から 1 2024 まで 1 2025