Montrouge, France, February 20 2024 - DBV Technologies (Euronext: DBV – ISIN: FR0010417345 –NASDAQ: DBVT), a clinical-stage biopharmaceutical company focused on treatments for food allergies, today announced two presentations at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting, February 23-26 in Washington, D.C.

A poster presentation by David Fleischer, M.D. of Children’s Hospital Colorado will describe the long-term (five-year) safety results of epicutaneous immunotherapy (EPIT) with Viaskin™ Peanut in peanut-allergic children aged 4-11 years in the PEOPLE (PEPITES Open-Label Extension) Phase 3 study.

An oral presentation, in collaboration with Icahn School of Medicine at Mount Sinai and Beckman Coulter Life Sciences, will describe how the immune modifying effects of Viaskin Peanut treatment over time were characterized in toddlers using a streamlined, novel approach to basophil activation testing (BAT) during the multicenter Phase 3 EPITOPE trial of in children aged 1-3 years.

DBV is sponsoring a non-CME Product Theater titled “Importance of Early Intervention for Peanut Allergy.” Professors Hugh Sampson, M.D. and Julie Wang, M.D., of the Icahn School of Medicine at Mount Sinai, and David Fleischer, M.D., of Children’s Hospital Colorado, will discuss the clinical benefits of early treatment initiation for peanut allergy through case-based learning. The panelists will also address how they navigate the shared decision-making process with families soon after a peanut allergy diagnosis, including factors related to clinical trial participation, such as eligibility and understanding barriers to enrollment. The Product Theater is scheduled for Saturday, February 24, from 10:00 a.m. to 10:30 a.m. EST in the Walter E. Washington Convention Center, Level 2, Hall D.

DBV is proud to sponsor the AAAAI Fellows-in-Training (FIT) Program reception on Friday, February 23. The private reception welcomes current allergy/immunology Fellows-in-Training.

DBV will host a booth (#567) in the AAAAI exhibit hall where attendees can learn more about epicutaneous immunotherapy with Viaskin, including our ongoing clinical trials in peanut-allergic children.

“The five-year safety data from our PEOPLE open-label extension study of Viaskin Peanut in children aged 4-11 years demonstrate that the long-term safety profile of Viaskin Peanut 250 μg is consistent with safety results observed in shorter (one-year, three-years) treatment periods,” said Pharis Mohideen, M.D. Chief Medical Officer at DBV Technologies.

“At DBV, we look forward to a day when allergists and families of children with peanut allergy have multiple approved treatment options and together decide on the best therapy for each child’s situation,” continued Dr. Mohideen. “DBV, is committed to generating robust, long-term safety data with Viaskin Peanut to aid in future shared decision-making. To that end, our ongoing clinical programs evaluating Viaskin Peanut in children ages 4-7 and toddlers ages 1-3 will each comprise approximately 600 patients in the active treatment arms.”

“As part of a collaboration with Icahn School of Medicine at Mount Sinai and Beckman Coulter Life Sciences, basophil activation testing, a blood test also known as BAT, was conducted on over 100 Viaskin Peanut participants aged 1-3 years, who were enrolled in DBV’s Phase 3 EPITOPE trial,” continued Dr. Mohideen. “This novel form of BAT, streamlined by Beckman Coulter to be more easily implemented at clinical sites, was used to help understand the immune modifying effects of epicutaneous immunotherapy over time. This could help advance our understanding of BAT as a potential treatment monitoring tool.”

DBV Abstract Details:

Oral Abstract Presentation

“A Streamlined Approach to Basophil Activation Testing for Longitudinal Characterization of Toddlers with Peanut Allergy During a Multi-Site Phase 3 Double-Blind Placebo-Controlled Trial of Epicutaneous Immunotherapy (EPIT)” will be presented by Dr. Jean-Marc Busnel (Beckman Coulter)

• Presentation date: Saturday, February 24, 2024
• Presentation time: 2:15 p.m. – 2:25 p.m. ET
• Presentation location: Convention Center, Level 3, Ballroom B

Poster Presentation

“Long-term Safety Results of Epicutaneous Immunotherapy (EPIT) with Viaskin Peanut in Peanut-Allergic Children Aged 4-11 Years in the Phase 3 PEOPLE Study” will be presented by Dr. David Fleischer, Associate Professor of Pediatrics at Children’s Hospital Colorado.

• Poster number: 379
• Session title: Treatment and Management of IgE-mediated Food Allergy
• Presentation date: Saturday, February 24, 2024
• Presentation time: 9:45 a.m. – 10:45 a.m. ET
• Presentation location: Convention Center, Level 2, Hall D

About DBV Technologies

DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies’ food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, 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-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

Forward Looking Statements

This press release may contain forward-looking statements and estimates, including, but not limited to, statements regarding the therapeutic potential of Viaskin™ Peanut and EPIT™ and DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, and 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 project herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth herein can be found in DBV Technologies’ regulatory filings with the Autorité des Marchés Financiers (“AMF”), DBV Technologies’ filings and reports with the U.S. Securities and Exchange Commission (“SEC”), and future filings and reports made with the AMF and SEC. 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.

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Viaskin and EPIT are trademarks of DBV Technologies.