DBV Technologies Reports $113.9 Million Net Loss for 2024, Focuses on Viaskin Peanut Development

DBV Technologies S.A., a clinical-stage biopharmaceutical company, reported a net loss of $113.9 million for the year ended December 31, 2024, compared to a net loss of $72.7 million in 2023. Operating income decreased significantly to $4.2 million in 2024 from $15.7 million in 2023, primarily due to a lower research tax credit and the termination of a collaboration agreement with Nestlé Health Science, resulting in a deferred revenue accrual reversal of $6.9 million and a loss on completion accrual reversal of $19.9 million. Research and development expenses increased by $29.1 million to $89.3 million in 2024, largely driven by increased clinical trial activity for Viaskin Peanut.

Significant changes in 2024 included the termination of the collaboration agreement with Nestlé Health Science and the completion of a $194 million private investment in public equity (PIPE) financing in June 2022. Subsequent to the reporting period, the company completed another private placement financing, raising initial net proceeds of $125.5 million in April 2025, with potential additional gross proceeds of up to $181.4 million from warrant exercises. This financing is expected to fund operations into June 2026, potentially extending to 2028 depending on warrant exercise. The company also completed subject screening for the VITESSE Phase 3 clinical trial in the third quarter of 2024, with topline results anticipated in the fourth quarter of 2025.

Strategic developments focused on advancing Viaskin Peanut through the regulatory approval process in both the United States and the European Union. In the U.S., the company received FDA guidance on a potential Accelerated Approval pathway for Viaskin Peanut in toddlers (ages 1-3), and initiated the COMFORT Toddlers supplemental safety study in the second quarter of 2025. The FDA also confirmed that safety data from the VITESSE study would be sufficient to support a BLA filing for children ages 4-7, eliminating the need for the COMFORT Children study. In the EU, the company received scientific advice from the EMA on a potential 1-7 year-old indication, planning to resubmit the MAA once additional data is available.

Key operational developments included the completion of subject screening for the VITESSE Phase 3 trial and the initiation of the COMFORT Toddlers study. The company employed 109 full-time employees as of December 31, 2024. The company's cash and cash equivalents were $32.5 million as of December 31, 2024, significantly lower than the $141.4 million reported at the end of 2023, reflecting the company's ongoing operating losses and investments in clinical development. The company anticipates continued significant expenses in the foreseeable future, particularly related to research and development, regulatory filings, and potential commercialization activities.

The company's outlook anticipates continued investment in Viaskin Peanut's development and regulatory submissions, with a BLA submission in the first half of 2026 for the 4-7 year-old age group and a BLA submission for the 1-3 year-old age group anticipated to be supported by the EPITOPE Phase 3 study and the COMFORT Toddlers study. The company also plans to advance its other product candidates and build its sales and marketing capabilities. However, the company acknowledges significant risks related to its financial condition, regulatory approvals, commercialization, and competition within the biopharmaceutical industry.