DBV Technologies Updates on Viaskin Peanut Program and Reports Q2 and H1 2024 Financial Results

Châtillon, France, July 30, 2024 – DBV Technologies, a clinical-stage biopharmaceutical company, has provided an update on its Viaskin Peanut Program targeting children and toddlers. The company also released its financial results for the second quarter and half-year of 2024.

Business Update

VITESSE Phase 3 Study
DBV Technologies is proceeding effectively with the enrollment for the VITESSE Phase 3 pivotal study, which focuses on children aged 4-7 years with peanut allergies. The study aims to evaluate the efficacy and safety of the modified Viaskin Peanut patch in about 600 subjects across various regions including the U.S., Canada, Europe, the UK, and Australia. The company anticipates completing participant recruitment by the end of Q3 2024.

Pharis Mohideen, M.D., Chief Medical Officer at DBV Technologies, acknowledged the diligent efforts of the participating sites and expressed optimism about meeting the recruitment goal. The company has seen encouraging momentum through its engagements at medical conferences and outreach efforts within the patient advocacy community and with study investigators.

COMFORT Toddlers Study
DBV Technologies has been in continuous dialogue with the FDA regarding the COMFORT Toddlers supplemental safety study, which focuses on toddlers aged 1-3 years with peanut allergies. The study protocol was initially submitted in November 2023, with FDA comments received in March 2024. The discussions have primarily revolved around patch wear-time experiences and recommendations for managing day-to-day variability.

DBV proposed an approach informed by EPITOPE efficacy data, emphasizing the user experience during the first 90 days of treatment. The company submitted a draft labeling proposal to the FDA, which includes data-driven instructions for identifying patients who are likely to respond effectively to the treatment (Label-in) and those who may not (Label-out). This labeling approach aims to optimize treatment by recommending a shared decision-making process between healthcare providers and caregivers for patients less likely to benefit from continued treatment.

Daniel Tasse, Chief Executive Officer of DBV Technologies, emphasized the company's commitment to families dealing with food allergies and expressed hope that the proposed labeling solution would expedite the regulatory pathway for Viaskin Peanut in young children.

Financial Highlights

Cash and Cash Equivalents
As of June 30, 2024, DBV Technologies reported cash and cash equivalents of $66.2 million, a decrease from $141.4 million at the end of 2023. The net decrease of $75.2 million is primarily attributed to operating activities, including costs associated with patient enrollment in the VITESSE Phase 3 clinical trial. The company has implemented cost-saving measures, extending its cash runway into Q1 2025.

DBV Technologies has incurred operating losses and negative cash flows since its inception. Based on current operations, the company expects its available cash to be sufficient to fund operations into early 2025. However, there remains substantial doubt about its ability to continue as a going concern without securing additional capital. The company is actively seeking further funding to support its research, development efforts, and potential market launch of Viaskin Peanut if approved.

Operating Income and Expenses
For the first half of 2024, DBV Technologies reported an operating income of $2.6 million, down from $4.5 million for the same period in 2023. This decline is mainly due to a reduced Research Tax credit as more study activities shift to North America.

Operating expenses for the same period amounted to $65.0 million, up from $50.7 million in 2023. This increase is driven primarily by research and development costs associated with the VITESSE Phase 3 clinical trial and preparatory activities for the COMFORT studies. Employee-related costs also rose by $3.1 million due to expanded headcount supporting clinical, regulatory, and quality activities in preparation for a Biologics License Application (BLA) submission.

Net Loss and Per Share Data
The company recorded a net loss of $60.5 million for the first half of 2024, compared to $44.8 million in the same period of 2023. On a per-share basis, the net loss was $(0.63) for the six months ended June 30, 2024. 

Conclusion
DBV Technologies continues to advance its Viaskin Peanut programs while managing financial challenges and regulatory dialogues. The company remains focused on developing effective treatments for children with peanut allergies and navigating the path to regulatory approval and market introduction.

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