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DBV Technologies is a clinical-stage biopharmaceutical company specializing in the development of innovative immunotherapy treatments for food allergies. The company leverages its proprietary Viaskin platform, which uses epicutaneous immunotherapy (EPIT) to deliver biologically active compounds through intact skin. DBV Technologies is focused on addressing unmet medical needs in food allergy treatment, with its lead product candidate, Viaskin Peanut, targeting peanut allergies in children.
- Viaskin Peanut - Develops a non-invasive epicutaneous patch therapy for treating peanut allergies in children, aiming to desensitize the immune system and reduce allergic reactions.
- Viaskin Milk - Advances a patch-based therapy for cow’s milk allergy, currently in Phase 2 clinical development, with potential applications for Eosinophilic Esophagitis (EoE).
- Viaskin Platform - Provides a proprietary technology platform for delivering microgram amounts of allergens through intact skin, targeting immune cells to promote desensitization and minimize systemic exposure.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Daniel Tassé ExecutiveBoard | Chief Executive Officer | Board Member at Regenxbio Inc.; Chair of Compensation Committee at Regenxbio Inc. | CEO of DBV Technologies since November 2018 and Board member since March 2019. | View Report → |
Dr. Pharis Mohideen Executive | Chief Medical Officer | Dr. Pharis Mohideen has served as Chief Medical Officer at DBVT since July 2019 and is a member of the Executive Committee. Previously, he served as Chief Medical Officer at Millendo Therapeutics from October 2014 to July 2019 and as Vice President of Clinical Development at Shionogi Inc. from June 2012 to October 2014. | ||
Virginie Boucinha Executive | Chief Financial Officer | Virginie Boucinha currently serves as the Chief Financial Officer at DBV Technologies since November 6, 2023 and is a member of the Executive Committee. Previously, she held senior leadership roles at Pierre Fabre Group and Sanofi, demonstrating significant expertise in finance and strategy. | ||
Adora Ndu Board | Board Member | Board Member at Acadia Pharmaceuticals; Adjunct Lecturer at Johns Hopkins University | Adora Ndu has served as a Board Member at DBV Technologies since May 2021 and brings extensive expertise in regulatory affairs and corporate governance, with previous leadership roles at the FDA and BioMarin Pharmaceutical. | |
Daniel B. Soland Board | Member of the Board of Directors | Member of the Board of Directors at Acadia Pharmaceuticals Inc. (since 2015) | Daniel B. Soland has served as a Member of the Board of Directors at DBV Technologies since March 2015 and is also on its Compensation Committee. He has a strong background in the pharmaceutical industry with previous executive roles at companies such as Idera Pharmaceuticals and ViroPharma. | |
Daniele Guyot-Caparros Board | Independent Director | Daniele Guyot-Caparros has served as an Independent Director at DBV Technologies since October 2022 and is a member of both the Audit and Compensation Committees. She brings extensive experience in corporate finance, business development, and governance. | ||
Julie O’Neill Board | Member of the Board of Directors | National Institute for Bioprocessing Research & Training; ICON plc; Hookipa Pharma Inc.; Achilles Therapeutics plc; ILC Dover, LP; Advancion (formerly Angus Chemical Company) | Julie O’Neill has served as a Member of the Board of Directors at DBVT since June 2017 and is currently the Chair of the Compensation Committee. She also supported CMC activities as a consultant from January 2019 to October 2019, playing a key role in the BLA resubmission for Viaskin™ Peanut. | |
Maïlys Ferrère Board | Director | Bpifrance - Director, Head of the Large Venture Investment Activity; Valneva S.A. - Member of the Board of Directors; Devialet - Member of the Board of Directors; Doctolib - Member of the Board of Directors | Maïlys Ferrère has served as a Director and a member of the Board of Directors at DBVT since June 2016, and she also serves on the Nominating and Governance Committee. | |
Michael J. Goller Board | Member of the Board of Directors | Partner at Baker Bros. Advisors LP; Board Member at BeiGene, Ltd.; Board Member at Terremoto Biosciences, Inc. | Michael J. Goller has served as a board member and Chair of the Nominating and Governance Committee at DBV Technologies since October 2015. He brings a strong background in investment banking and corporate development as a Partner at Baker Bros. Advisors LP and holds board positions at BeiGene, Ltd. and Terremoto Biosciences, Inc.. | |
Michel de Rosen Board | Non-Executive Chairman of the Board of Directors | Board Member at Forvia | Michel de Rosen has served at DBVT since May 2018, and he was appointed Non-Executive Chairman of the Board in March 2019. He has held multiple leadership roles across industries, including an active board membership at Forvia since 2017. | |
Ravi M. Rao Board | Member of the Board of Directors | Chief Medical Officer at Sitryx Therapeutics; Venture Partner at SV Health Investors; Independent Director at Autous | Ravi M. Rao has been serving as a member of DBV Technologies' Board of Directors since May 2021. He is also a member of the Nominating and Governance Committee and brings extensive clinical and executive experience from roles at GlaxoSmithKline, Aeglea Biotherapeutics, Swedish Orphan Biovitrum, Oxford Biomedica, Sitryx Therapeutics, SV Health Investors, and Autous. | |
Timothy E. Morris Board | Member of the Board of Directors | Board Member at Aquestive Therapeutics, Inc.; Board Member at Univercells SA; Board Member at Humanetics Corporation; Sole Member at Aacolade Pharma LLC | Timothy E. Morris has served as a member of the Board of Directors at DBVT since March 2021 and as Chairperson of the Audit Committee since October 3, 2022. |
- How exactly will you quantify the patch wear-time experience to differentiate between label-in and label-out groups, and can you clarify which specific metrics (e.g., average daily wear time, variability) will be used to correlate with long-term clinical efficacy?
- With the FDA currently reviewing your draft labeling proposal and given their recent backlogs, what are the potential implications for the timing and feedback for both the COMFORT Toddlers and COMFORT Children studies?
- The EPITOPE study shows an overall 67% response rate; could you detail how you plan to refine this further in your label-in subgroup and what additional data may be required to solidify this enrichment strategy with the FDA?
- Considering your reported nonrecurring costs of $24 million in H1, can you specify which of these costs might recur in future periods and what strategies are in place to mitigate any impact on your operating expenses?
- Given that cost-saving measures have extended your cash runway into Q1 2025, what are the risks or operational challenges that could potentially shorten this runway, and how might these factors affect your ongoing clinical and regulatory programs?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
Aimmune Therapeutics, Inc. | There is one treatment that is specific for peanut allergy in children 1 to 17 years of age, a proprietary form of oral immunotherapy (OIT) which was approved by the FDA and the European Commission: Palforzia, a formulation of peanut flour developed by this company. Nestlé S.A. acquired the company in October 2020, and later divested the Palforzia business to Stallergenes Greer in September 2023. |
Sanofi’s strategic alliance partner entered into a clinical collaboration with another competitor to evaluate treatment with Palforzia in combination with Dupilumab in peanut allergic patients. Regeneron commenced a Phase 2 clinical trial in October 2018 under this collaboration. This potential competitive dynamic may make Sanofi less inclined to continue or renew their manufacturing arrangement with DBV Technologies on commercially reasonable terms or at all. | |
Stallergenes Greer | This company acquired the Palforzia business from Nestlé S.A. in September 2023, which is a proprietary form of oral immunotherapy (OIT) specific for peanut allergy in children 1 to 17 years of age. |
Recent press releases and 8-K filings for DBVT.
- FDA Alignment: DBV Technologies secured an FDA agreement confirming that safety data from its ongoing Phase III studies will suffice for the BLA filing for children 4 to 7—eliminating an extra 6‐month safety study and accelerating submission to H1 2026.
- Robust Financing Round: The company announced a financing round of up to $306.9 million, with $125.5 million received upfront and a potential additional $181.4 million upon warrant exercisability to support independent BLA submissions for toddlers and children 4 to 7.
- Share Capital Increase: DBV is executing a share capital increase by issuing new shares with attached warrants (ABSA and PFW-BS-PFW), targeting net proceeds of €106.3 million and potential gross proceeds of up to €284.5 million if all warrants are exercised.
- Use of Proceeds: The funds will support working capital, advance development of the Viaskin Peanut patch, and finance preparation for a Biologics License Application and potential US commercial launch.
- FDA accepts the safety exposure data from the VITESSE Phase 3 trial and its Open Label Extension for the Viaskin peanut patch in 4‑7-year-olds, eliminating the need for the COMFORT Children supplemental study.
- BLA submission for the Viaskin peanut patch is now expected in the first half of 2026, potentially accelerating product launch by about one year, alongside the announcement of unaudited 2024 financial results.