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Jun 30, 2024
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DBV Technologies Q2 2024 Earnings Report
DBV Technologies reported financial results and provided business updates
Key Takeaways
DBV Technologies reported financial results for the second quarter of 2024, with a cash balance of $66.2 million. Enrollment for the VITESSE Phase 3 pivotal study is on track, and the company submitted a labeling proposal to the FDA for the COMFORT Toddlers study.
VITESSE enrollment in peanut allergic 4-7-year-olds is on-track and recruitment is expected to be complete by end of Q3 2024.
DBV submitted a labeling proposal, informed by the EPITOPE efficacy data, to the Food and Drug Administration (FDA) to address the FDA’s protocol queries regarding patch wear-time in COMFORT Toddlers
DBV closes Q2 2024 with a cash balance of $66.2 million; due to cost-saving measures, the Company’s cash runway is extended into Q1 2025
DBV is awaiting FDA’s response to the proposed labeling approach which was submitted on June 28th.
DBV Technologies
DBV Technologies
Forward Guidance
DBV Technologies is awaiting FDA’s response to the proposed labeling approach which was submitted on June 28th and expects that its balance of cash and cash equivalents will be sufficient to fund its operations into Q1 2025 due to the implementation of cost-savings measures.
Positive Outlook
- VITESSE enrollment in peanut allergic 4-7-year-olds is on-track and recruitment is expected to be complete by end of Q3 2024
- Sites in the U.S., Canada, Europe, Australia, and the UK are working hard to continue screening and enrolling subjects so that we are on-track to reach our goal of the last subject into VITESSE by the end of Q3 2024
- DBV submitted to the FDA draft labeling for Section 2 – Dosing and Administration, for a potential Viaskin Peanut Prescribing Information (PI), along with comprehensive supportive data and analyses
- The proposed PI recommends continuation of treatment for Label-in patients
- The FDA Office of Vaccine Research and Review stated that non-COVID related backlogs were behind them, that the Division was caught-up, allowing more time for interactions with sponsors
Challenges Ahead
- As of July 30th, DBV’s available cash and cash equivalents are not projected to be sufficient to support the Company’s operating plan for at least the next 12 months.
- There is substantial doubt regarding its ability to continue as a going concern.
- The Company has incurred operating losses and negative cash flows from operations since inception.
- The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions
- A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.