DBV Technologies SA

DEF 14A 1 d695742ddef14a.htm DEF 14A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

SCHEDULE 14A

Proxy Statement Pursuant to Section 14(a) of the

Securities Exchange Act of 1934

Filed by the Registrant ☒

Filed by a Party other than the Registrant ☐

Check the appropriate box:

(Name of Registrant as Specified In Its Charter)

(Name of Person(s) Filing Proxy Statement, if other than the Registrant)

Payment of Filing Fee (Check all boxes that apply):

Dear Fellow DBV Shareholders,

At DBV, our mission remains steadfast in addressing the real-world needs of families with children living with life-threatening food allergies who are actively seeking treatment options. In a context of a shift in the landscape of allergy management, moving from a passive approach of avoidance to an active and targeted treatment strategy, DBV is well positioned to play a pivotal role as a key component in the allergists’ toolkit for managing food allergy. To accomplish this, we remain focused on three pillars: safety, efficacy, and ease of use with a target population of peanut-allergic children aged 1 through 7 years old.

The publication of our EPITOPE study in the prestigious New England Journal of Medicine (NEJM) was a significant achievement in 2023. The publication of this groundbreaking study, focused on peanut-allergic toddlers aged 1 through 3 years-old, underscores the significance and importance of our product and its potential. Notably, the study data shows that 67% of subjects treated with Viaskin™ Peanut 250 µg met response criteria after 12 months, compared to 33.5% in the placebo arm.

Late last year, DBV had the opportunity to give a late-breaking presentation, at the American College of Allergy, Asthma & Immunology (ACAAI), of the EPITOPE open-label extension. Highlighted in that presentation was a 24-month readout of the interim data which showed a continued benefit of long-term treatment with Viaskin Peanut. Significantly, 56% of children in the open-label extension were able to consume an equivalent of 12-14 peanuts without experiencing an allergic reaction during theyear-two food challenge. Moreover, 81% achieved an increase in eliciting dose from a median of 100mg (the equivalent of approximately 1/3 of a peanut) to 3-4 peanuts. We view this data as being highly meaningful and motivating to our continued mission to bring Viaskin Peanut to market.

In 2023, we launched the VITESSE study, focusing on safety and efficacy in 4 through 7-year-olds, recognizing this is an age group where children’s lifestyle involves an increase in social interactions, school, and extracurricular activities. As an update, enrollment is ongoing and we expect to screen the last subject in VITESSE in 2024.

As the typical age of diagnosis for a peanut allergy in children is between the ages of 1 through 5 years old, we believe that initiating immunotherapy with Viaskin Peanut in children 1 through 7 is optimal. Parents are highly motivated to seek treatment upon diagnosis. We strive to protect peanut allergic children in this age group from accidental peanut consumption and hope to provide greater peace of mind for the children and all their loved ones. The three pillars of Viaskin Peanut: safety, efficacy, and ease of use without restrictions on daily life, are intended to achieve that outcome. Furthermore, as our data shows, and like other immunotherapies with the potential to reeducate the immune system, the earlier treatment is initiated, the better the clinical outcome, as the immune system is particularly susceptible to being reeducated in early life.

DBV continues to expand a substantial clinical dataset, with already close to 1,700 children on active treatment across age groups when we combine data from our prior Phase 3 trials, including approximately 600 toddlers aged 1 through 3 years and 1,100 children aged 4 through 7. We are accumulating the largest ever cumulative exposure to an investigational product in pediatric food allergy. More than one million Viaskin Peanut patches have been applied to peanut-allergic children in our trials—which is the equivalent to more than one million days of therapy.

Based on the number of children on active treatment, Viaskin Peanut is clearly a well-studied therapeutic, which gives us confidence in the potential of Viaskin as a novel treatment option and the science of epicutaneous immunotherapy as a platform. The allergist community and patient advocacy groups are emphatic in their support of Viaskin Peanut as a treatment option and are eager to welcome it when it is approved and becomes commercially available. Therefore, we are dedicating all our efforts towards filing parallel Biologic License Applications (BLAs) in 1 through 3-year-olds and 4 through 7-year-olds, reflecting our mission to advancing treatment options for young children living with peanut allergy.

To accomplish this, our commitment to financial discipline and focused spending remains a cornerstone of our culture andday-to-day life. We appreciate the support and confidence of our shareholders so that we may continue to prioritize the completion of our studies for Viaskin Peanut. The PIPE and ATM offerings conducted in 2022 and 2023 allowed us to fuel Viaskin Peanut development progress in 2023. More than 90% of our expenditures and efforts are directed toward operations for Viaskin Peanut’s clinical development and preparing for BLA filings. With a cash balance of $141 million atyear-end 2023, we will continue to employ the requisite financial discipline necessary to give us the ability to further advance Viaskin Peanut development throughout the year.

While Viaskin Peanut is our near-term priority program, our belief in epicutaneous immunotherapy as a platform is reflected in the Viaskin Milk program which is being readied to advance to Phase 2b for both cow’s milk allergy and cow’s milk induced eosinophilic esophagitis (EoE). In addition, we continue to investigate the potential application of Viaskin in other immunologic indications with a high unmet need, such as celiac disease.

Our mission-driven focus centers on people living with food allergies and other immunologic conditions with significant unmet medical need. We are building a future with more options and better outcomes for these people and their families. We are grateful for the ongoing support from our shareholders in realizing this vision.

In closing, I wish to state that we believe our current stock price undervalues our company and does not reflect the potential of Viaskin Peanut. We remain steadfast in our efforts to bring Viaskin Peanut to market.

Thank you for your belief in DBV Technologies and its future.

Sincerely,

/s/ Michel de Rosen

Michel de Rosen

April 26, 2024

177-181 Avenue Pierre Brossolette

92120 Montrouge France

NOTICE OF ANNUAL COMBINED GENERAL MEETING OF SHAREHOLDERS

To Be Held at 10:00 AM Paris Time on May 16, 2024

To Shareholders of DBV Technologies S.A.:

The 2024 Annual Combined General Meeting of Shareholders of DBV Technologies S.A. (the “Company”), a French société anonyme, will be held on May 16, 2024, at 10:00 AM Paris time at the Company’s new headquarters located at 107 avenue de la République 92320 Châtillon, France.

These items of business are more fully described in the proxy statement accompanying this Notice.

On May 16, 2024, starting at 10:00 AM Paris time, the Annual General Meeting will be webcast with live audio on our website https://www.dbv-technologies.com. The recorded webcast of the Annual General Meeting will remain accessible on the Company’s website for five (5) years following the date of the Annual General Meeting.

These proxy materials will be mailed by Citibank, N.A. (the “Depositary”) commencing on or about April 30, 2024, to all holders of the Company’s American Depositary Shares (“ADSs”), each representingone-half of one ordinary share of the Company, having a nominal value of €0.10 per share (the “Ordinary Shares” or “Shares”). Our registrar, Société Générale Securities Services, will commence mailing proxy materials to all holders of the Company’s Ordinary Shares on or about April 29, 2024, in accordance with French law.

In accordance with Article R.225-85 of the French Commercial Code, if you are holder of Ordinary Shares that are registered in your name or in the name of an intermediary duly registered on your behalf as of May 14, 2024 at zero hour Paris time, which is the second business day prior to the meeting (the “Ordinary Share Record Date”), either in the registered share accounts or in the bearer share accounts held by their authorized intermediary, you will be eligible to vote your Ordinary Shares . You may (i) vote in person at the Annual General Meeting (ii) grant your voting proxy directly to the chairman of the Annual General Meeting (iii) grant your voting proxy to another shareholder, your spouse, or your partner with whom you have entered into a civil union, (iv) vote by submitting your proxy card by mail or (v) vote by electronic mail via the secure platform Votaccess. If you vote in advance of the Annual General Meeting, you may change your vote provided that your request is received by the Company within the applicable time limits described in this proxy statement.

If you hold ADSs, you may instruct the Depositary, either directly or through your broker, bank or other nominee, how to vote the Ordinary Shares underlying your ADSs. Please note that only holders of Ordinary Shares, and not ADS holders, are entitled to vote directly at the Annual General Meeting. The Depositary has fixed a record date for the determination of holders of ADSs who shall be entitled to give such voting instructions. We have been informed by the Depositary that it has set the ADS record date for the Annual General Meeting as April 25, 2024 (the “ADS Record Date”). If you wish to have your votes cast at the meeting, you must obtain, complete and timely return at or prior to 10:00 AM Eastern Time on May 10, 2024, a voting instruction form from the Depositary, if you are a registered holder of ADSs, or from your broker, bank or other nominee in accordance with any instructions provided therefrom.

We appreciate your continued support of DBV Technologies S.A. and look forward to receiving your vote.

By order of the Board of directors,

/s/ Daniel Tassé

Daniel Tassé

Chief Executive Officer

YOUR VOTE IS IMPORTANT. Please read the proxy statement and the accompanying materials. Whether or not you expect to attend the meeting, no matter how many Ordinary Shares or ADSs you own, please submit your proxy card or voting instruction form, as applicable, in accordance with the procedures described above.

Important Notice Regarding the Availability of Proxy Materials for the

Shareholder Meeting to be Held on May 16, 2024:

The proxy statement and annual report are available on the Investors section of our website https://www.dbv-technologies.com/investor-overview/sec-filings/

Our Depositary, Citibank, N.A., will commence mailing the proxy materials to all ADS holders on or about April 30, 2024. Our registrar, Société Générale Securities Services, will commence mailing the proxy materials to all holders of our Ordinary Shares on or about April 29, 2024, in accordance with French law and requirements.

Along with this proxy statement, we are also providing our 2024 Annual Report on Form 10-K, which includes our financial statements prepared in accordance with U.S. GAAP for the fiscal year ended December 31, 2023.