DBVT

EX-99.1

2 d137106dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Press Release

Châtillon, France, October 28, 2026

DBV Technologies Reports Third Quarter 2026 Financial Results and Business Update

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Submitted the Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in children aged 4-7 Years and requested Priority Review

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Accelerated Commercial Readiness towards the launch of the VIASKIN® Peanut Patch in children aged 4-7 years in the US, if approved

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Reported cash and cash equivalents of $165.7 million as of September 30, 2026, funding into third quarter of 2027

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DBV will host a conference call today, October 28, at 5:00pm ET

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a late-stage specialty biopharmaceutical company, today reported financial results for the Third Quarter of 2026. The quarterly and nine months financial statements were approved by the Board of Directors on October 28, 2026.

“The third quarter marked a defining step in DBV’s evolution from a clinical-stage company into a commercial organization. With our BLA now submitted for children aged 4 through 7 years, and our planned BLA in toddlers aged 1 through 3 years, we are concentrating our efforts on the areas that will advance the company most meaningfully,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “We are grateful for the productive, ongoing dialogue with the FDA about both BLAs. As the regulatory dialogue progresses, we have every function across the company aligned on supporting a complete and efficient review of both dossiers, advancing manufacturing readiness alongside our contract manufacturing partner, and preparing to execute our launch plans with discipline.”

Third Quarter 2026 Operational Highlights and 2027 Business Updates

Regulatory Execution

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Submitted the Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in children aged 4 through 7 Years and requested Priority Review.

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The BLA is supported by the Phase 3 VITESSE trial, which enrolled 654 children and is the largest immunotherapy trial to date in this population.

Corporate and Financial Position

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Funded into the third quarter of 2027, enabling continued execution through the regulatory review process and commercial preparedness, including continued investment across core functions required to potentially launch and support the long-term success of the VIASKIN® Peanut Patch brand, including Medical Affairs, Sales, Market Access, Marketing, Account Management, and Pharmacovigilance.

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Refreshed the Company’s $150 million ATM program and completed $50 million of gross proceeds sale of ADSs to RA Capital Management.

Manufacturing Progress

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Continued working closely with Fareva Amboise (Fareva), the Company’s contract manufacturing organization, on remediation activities following the April 2026 FDA Warning Letter to Fareva.

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Maintained a direct line of sight into remediation work specific to the VIASKIN® Peanut Patch production, which is led by external specialists against a detailed project plan shared by Fareva with DBV.

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Received confirmation from Fareva that it has responded to FDA in accordance with regulatory timelines and has provided monthly updates to the Agency.

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Based on ongoing collaboration with Fareva, a target date for the Pre-Approval Inspection (PAI) was included in the BLA, in line with FDA regulations and standard industry practices.

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The target date for the PAI falls after the date by which Fareva expects to complete remediation.

Toddler Program

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DBV has held discussions with the Agency on how to ensure a timely review of the BLA for toddlers aged 1 through 3 years following the recent submission of the 4-through-7 BLA, including a potential rolling submission of the 1-through-3 BLA. The same review Team will review both BLAs. FDA indicated that a review of the 1-through-3 BLA initiated shortly after the review of the 4-through-7 BLA would allow the Agency to build on the learnings from their review and the efficiencies expected from the meaningful content overlap of the two BLAs. It would provide DBV and FDA the opportunity to align on the form, content, and best timing of the components of the 1-through-3 BLA submission, in support of an efficient review of both BLAs.

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DBV will continue the regulatory dialogue with FDA over the next few months and expects to submit the toddler BLA in 2027. DBV will provide an update once the FDA discussions regarding the Company’s toddler program have been finalized.

Upcoming Milestones

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File acceptance for the BLA in children aged 4 through 7 years. Determination by FDA whether the BLA for children aged 4 through 7 years is sufficiently complete to begin the full substantive review, including whether Priority Review is granted, expected in the fourth quarter of 2026.

Financial Highlights for the Third Quarter Ended September 30, 2026

The Company’s inter

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