DBV Technologies SA
For the period ended Jun 11, 2025. Filed May 15, 2025.
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Jun 11, 2025 · Filed May 15, 2025
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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
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Filed by a Party other than the
Registrant
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| ☐ | Preliminary Proxy Statement |
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| ☐ | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
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| ☒ | Definitive Proxy Statement |
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| ☐ | Definitive Additional Materials |
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| ☐ | Soliciting Material Pursuant to § 240.14a-12 |
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Dear Fellow DBV Shareholders,
Each year, I begin my letter to you with the reminder that DBV was founded upon the belief that children with food allergies, their families, and the allergists who treat them need, and deserve, multiple treatment options. That belief remains the core tenet of DBV today – it guides our corporate strategy and drives our employees each day.
In recapping what was a very eventful 2024 for DBV, I must start by addressing the longer than expected time needed to initiate the COMFORT Toddlers pivotal safety study in peanut allergic children ages 1 – 3-years-old. In early 2024, the U.S. Food and Drug Administration (FDA) added significant and unexpected requirements for data to be generated in the Comfort Toddlers trial, requirements which would have made the execution of that trial very difficult. Thus, much of 2024 was focused on dialogue and data sharing with FDA, and, through that process, securing alignment with the Agency on a reasonable path forward for the Viaskin® Peanut patch in the 1 – 3-year-old age group. During this time, the Company’s cash runway was depleted, which put pressure on the stock price. Although the time we invested in securing that alignment was significant, it was critical to best explain epicutaneous immunotherapy and the Viaskin Peanut patch, not only for the toddlers program but, just as essential, to the whole Viaskin platform going forward. In this dialogue, we wish to acknowledge the constructive role played by senior management at FDA’s reviewing division for the Viaskin Peanut patch, the Office of Vaccine Research and Review, in aiding this alignment. Such constructive FDA exchanges around food allergy immunotherapy, an area of breakthrough science, were a model for FDA-industry partnerships. We certainly wish to continue this type of dialogue with the Agency in the future.
Having navigated and resolved these issues, DBV is now well-positioned for success. Doing so required patience, dedication, and exceptional leadership from DBV’s executive team and colleagues. I am pleased that the Company met and addressed these challenges thanks to the strong voice of patients, investigators and medical experts, a focus on good regulatory science to satisfy the Agency, and yes, perseverance – resulting in FDA granting an Accelerated Approval pathway for the Viaskin Peanut patch in 1 – 3-year-olds. This clear, expedited alignment means that toddlers with peanut allergy may have the potential to receive an FDA approved product faster, with robust safety and efficacy data. Moreover, this solid foundation will serve DBV well as the Company progresses regulatory pathways for the Viaskin Peanut patch in both 1 – 3 and 4 – 7-year olds. On behalf of the Board of Directors, we are grateful for this work and to see the Viaskin peanut patch progress expeditiously towards potential approval for those who are so eagerly awaiting its arrival.
DBV continues to expand a substantial clinical dataset, with more than 1,800 children on active treatment across age groups and programs when we combine data from our prior Phase 3 trials, including more than 380 toddlers aged 1 through 3 years and 745 children aged 4 through 7. The Company is accumulating the largest ever cumulative exposure to an investigational product candidate in pediatric food allergy. More than one million Viaskin Peanut patches have been applied to peanut-allergic children in our trials to date, which is equivalent to more than one million days of therapy. We are pleased to have completed recruitment of the VITESSE Phase 3 pivotal study in children 4 – 7 years-old in August 2024 and areon-track for topline results toread-out in the fourth quarter 2025. In parallel, clinical work to initiate the COMFORT Toddlers supplemental safety study in 1 – 3 year olds progressed and ison-track for the first patient to be screened in the second quarter of 2025.
In addition to DBV’s clinical trials to support the Viaskin Peanut patch regulatory pathway, there continues to be growing interest in the academic medical field in learning more about epicutaneous immunotherapy with the Viaskin Peanut patch. Three different high-quality journals invited top experts to contribute review manuscripts on this topic and the DBV Product Theater at the American Academy of Allergy, Asthma, and Immunology (AAAAI) meeting resulted in record-breaking attendance. Further, based on available data from DBV clinical trials, epicutaneous immunotherapy was included in the European Academy of Allergy and Clinical Immunology (EAACI) guidelines as a recommended treatment option for peanut allergy, if available.
In 2024, DBV continued to exercise careful expense management and remained highly disciplined in our cash usage. The Company closed the year with $32.5 million in cash reserves. Prudently, resources were directed to support the VITESSE Phase 3 pivotal study and preparations for the COMFORT Toddlers supplemental safety study. In 2024, not only did DBV achieve alignment with FDA on the 1 – 3 year-old Biologics License Application (BLA), but this constructive dialogue extended into the first quarter of 2025 and led to the agreement by FDA that the safety data generated in the VITESSE trial in 4 – 7-year-olds will be sufficient to support a separate BLA, allowing DBV to accelerate the potential launch of Viaskin Peanut in this age group by as much as a year. These regulatory alignments laid the groundwork for a transformational financing of up to $306.9 million, including $125.5 million upfront, that was successfully completed in March 2025. Participants in the financing included a mix of existing and new highly regarded healthcare institutional investors who share our vision for the potential of the Viaskin Peanut patch. Without the thoughtful planning and hard work conducted in 2024, the Company’s successes in the early months of 2025 would not have been possible. We are pleased to say that DBV is now fully funded through the commercial launch of the Viaskin Peanut patch, if approved by FDA.
In the fourth quarter of 2024, a new federal administration was elected to office in the United States, resulting in sweeping policy changes and reductions in the federal workforce. At the same time, worldwide conflict and growing geopolitical tensions contribute to instability across financial markets. DBV is not immune to these events, but we are steadfast in our commitment to our patients, the broader food allergy community who believes in what we do, and our shareholders. With conviction, DBV remains a champion of superb clinical science and to addressing the urgent unmet medical need that exists for food allergic patients and their families. The work we do matters and has impact. DBV is committed to bringing the Viaskin Peanut patch to potential approval in the United States and European Union. As I have stated before, I state again: Our confidence in the significant therapeutic and commercial potential of Viaskin Peanut, and the broader Viaskin technology platform, is unwavering.
Sincerely,
/s/ Michel de Rosen
Michel de Rosen
May 15, 2025
107 avenue de la République
92320 Châtillon France
NOTICE OF ANNUAL COMBINED GENERAL MEETING OF SHAREHOLDERS
To Be Held at 2:00 PM Paris Time on June 11, 2025
To Shareholders of DBV Technologies S.A.:
The 2025 Annual Combined General Meeting of Shareholders of DBV Technologies S.A. (the “Company”), a French société anonyme, will be held on June 11, 2025, at 2:00 PM Paris time at the Company’s headquarters located at 107 avenue de la République 92320 Châtillon, France (the “2025 Annual General Meeting” or, more generally, the “Annual General Meeting”, the “General Meeting” or the “Meeting”).
On June 11, 2025, starting at 2:00 PM Paris time, the 2025 Annual General Meeting will be webcast with live audio on our website https://www.dbv-technologies.com. The recorded webcast of the 2025 Annual General Meeting will remain accessible on the Company’s website for at least the minimum legal and regulatory period from its publication online, following the date of the 2025 Annual General Meeting.
| 1. | Approval of the annual financial statements for the year ended December 31, 2024 |
| 2. | Approval of the consolidated financial statements for the year ended December 31, 2024 |
| 3. | Allocation of income for the year ended December 31, 2024 |
| 4. | Allocation of the accumulated deficit to the “Additional paid-in capital” |
| 5. | Approval of the agreement relating to the subscription of pre-funded warrants issued by the Company signed on March 27, 2025 between the Company and Baker Bros Advisors LP in accordance with Articles L.225-38 and seq. of the French Commercial Code |
| 6. | Approval of the agreement relating to the subscription of pre-funded warrants issued by the Company signed on March 27, 2025 between the Company and Bpifrance Participations S.A. in accordance with Articles L.225-38 and seq. of the French Commercial Code |
| 7. | Approval of the Registration Right Agreement signed on March 27, 2025, in particular between the Company, Baker Bros Advisors and Bpifrance Participations S.A. in accordance with Articles L.225-38 and seq. of the French Commercial Code |
| 8. | Renewal of Mr. Michel de Rosen, as director |
| 9. | Renewal of Mr. Timothy Morris, as director |
| 10. | Renewal of Mr. Daniel Soland, as director |
| 11. | Approval of the information set out in section I of Article L.22-10-9 of the French Commercial Code on the compensation of corporate officers for the year ended December 31, 2024 |
| 12. | Approval of the fixed, variable and non-recurring components of overall compensation and benefits of all types paid or assigned during the year ended December 31, 2024, to Mr. Michel de Rosen, Chairman of the Board of Directors |
| 13. | Approval of the fixed, variable and non-recurring components of overall compensation and benefits of all types paid or assigned during the year ended December 31, 2024, to Mr. Daniel Tassé, Chief Executive Officer |
| 14. | Advisory opinion on the compensation of named executive officers other than the Chief Executive Officer |
| 15. | Increase of the total remuneration (annual budget) allocated to Directors |
| 16. | Approval of the compensation policy for the Chairman of the Board of Directors for the year ending December 31, 2025 |
| 17. | Approval of the compensation policy for the Directors for the year ending December 31, 2025 |
| 18. | Approval of the compensation policy for the Chief Executive Officer and Deputy Chief Executive Officer for the year ending December 31, 2025 |
| 19. | Authorization to be granted to the Board of Directors to buy back company shares on the Company’s behalf pursuant to Article L.22-10-62 of the French Commercial Code |
Within the authority of the extraordinary shareholders’ meeting:
| 20. | Delegation to be granted to the Board of Directors to reduce the share capital by cancellation of shares pursuant to Article L.22-10-62 of the French Commercial Code |
| 21. | Delegation of authority to be granted to the Board of Directors to issue ordinary shares and/or equity securities giving access to other equity securities or to the allocation of debt securities and/or securities giving access to ordinary shares with preferential subscription rights |
| 22. | Delegation of authority to be granted to the Board of Directors to issue ordinary shares and/ or equity securities giving access to other equity securities or to the allocation of debt securities, and/or securities giving access to equity securities to be issued, without preferential subscription rights by means of a public offer excluding the offers set out in paragraph 1 of Article L.411-2 of the French Monetary and Financial Code, and/or as consideration for securities in the context of a public exchange offer |
| 23. | Delegation of authority to be granted to the Board of Directors to issue ordinary shares and/or equity securities giving access to other equity securities or to the allocation of debt securities, and/or securities giving access to equity securities to be issued, without preferential subscription rights by means of a public offer referred to in paragraph 1 of Article L.411-2 of the French Monetary and Financial Code |
| 24. | Delegation of powers to be granted to the Board of Directors to issue ordinary shares and/or equity securities giving access to other equity securities or to the allocation of debt securities and/or securities giving access to ordinary shares, without preferential subscription rights in favor of one or more persons to be designated by the Board of Directors |
| 25. | Delegation of authority to be granted to the Board of Directors to issue ordinary shares, giving, as the case may be, access to ordinary shares or the allocation of debt securities (of the Company or a group company) and/or securities giving access to ordinary shares (of the Company or a group company), without preferential subscription rights in favor of a category of persons satisfying determined characteristics |
| 26. | Delegation of authority to be granted to the Board of Directors to decide on the issue of ordinary shares to be issued immediately or in the future by the Company, without preferential subscription rights in favor of a category of persons satisfying determined characteristics within the framework of an equity financing agreement on the United States stock market known as “At-The-Market” or “ATM Program” |
| 27. | Delegation of authority to be granted to the Board of Directors to increase the number of securities to be issued in the event of a capital increase with or without preferential subscription rights, in the event of excess demand |
| 28. | Delegation to be granted to the Board of Directors to increase the share capital by issuance of ordinary shares and/or securities giving access to the share capital within the limits set by the applicable legal and regulatory provisions on the date of the capital increase in consideration for contributions in kind of securities or securities giving access to the share capital |
| 29. | Delegation of authority to be granted to the Board of Directors to decide on any merger-absorption, spin-off or partial contribution of assets |
| 30. | Delegation of authority to be granted to the Board of Directors to issue ordinary shares giving, as the case may be, access to ordinary shares or to the allocation of debt securities (of the Company or of a group company), and/or securities giving access to ordinary shares (of the Company or of a group company), in the context of a merger, spin-off or partial contribution of assets decided by the Board of Directors pursuant to the delegation referred to in the twenty-ninth resolution |
| 31. | Overall limit on the maximum authorized amounts set under the resolutions twenty-second, twenty-third, twenty-fourth, twenty-fifth, twenty-sixth, twenty-eighth and thirtieth resolutions |
| 32. | Delegation of authority to be granted to the Board of Directors to increase the capital by means of the incorporation of reserves, profits and/or premiums |
| 33. | Delegation of authority to be granted to the Board of Directors to increase the capital by the issue of ordinary shares and/or securities giving access to the share capital, without preferential subscription rights in favor of the members of a company savings plan pursuant to Articles L.3332-18 and seq. of the French Labor Code |
| 34. | Delegation of authority to be granted to the Board of Directors to issue warrants (BSA), subscription and/or acquisition of new and/or existing warrants (BSAANE) and/or subscription and/or acquisition of new and/or existing redeemable warrants (BSAAR) without preferential subscription rights in favor of a category of persons |
| 35. | Authorization to be granted to the Board of Directors to allocate for free existing and/or to be issued shares to employees and/or certain corporate officers of the company or related companies or economic interest groups |
| 36. | Authorization to be granted to the Board of Directors to grant stock options to employees and/or certain officers of the Company or related companies or economic interest groups |
| 37. | Ratification of the amendment to Article 11 of the bylaws |
| 38. | Amendment of Article 13 of the Company’s bylaw to set the age limit for the Chairman of the Board of Directors at 80 years |
| 39. | Powers to complete formalities |
These items of business are more fully described in the proxy statement accompanying this Notice.
These proxy materials will be mailed by Citibank, N.A. (the “Depositary”) commencing on May 19, 2025, to all holders of the Company’s American Depositary Shares (“ADSs”), each representing five 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 May 19, 2025.
In accordance with Article R.22-10-28 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 June 9, 2025 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 Board of Directors (iii) grant your voting proxy to another shareholder or to any other person namely appointed, (iv) vote by submitting your proxy card by mail or (v) vote by electronic mail via the secured platform Votaccess. Any shareholder who has already requested an admission card, sent a proxy, or cast a postal vote, may no longer choose another means of participating in the Annual General Meeting.
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 2025 Annual General Meeting as May 12, 2025 (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 June 5, 2025, 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 June 11, 2025:
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 May 19, 2025. Our registrar, Société Générale Securities Services, will commence mailing the proxy materials to all holders of our Ordinary Shares on May 19, 2025.
Along with this proxy statement, we are also providing our 2024 annual report on Form 10-K (the “Annual Report”, as amended on April 28, 2025, which includes our financial statements prepared in accordance with U.S. GAAP for the fiscal year ended December 31, 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.