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Dec 31, 2023
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DBV Technologies Q4 2023 Earnings Report
DBV Technologies reported its full year 2023 financial results and business update.
Key Takeaways
DBV Technologies reported cash and cash equivalents of $141.4 million as of December 31, 2023. The company experienced a net loss of $72.7 million for the year ended December 31, 2023. They are focused on completing enrollment in VITESSE, their Phase 3 efficacy and safety trial in children.
Advanced Viaskin™ Peanut clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old).
Strengthened executive leadership team in preparation for BLA submission.
Confirmed EPITOPE study is sufficient for clinical portion of a BLA.
Initiated VITESSE, a Phase 3 clinical trial to evaluate the efficacy and safety of the circular Viaskin Peanut patch in peanut-allergic children aged 4 through 7 years.
DBV Technologies
DBV Technologies
Forward Guidance
DBV Technologies anticipates several key events in 2024, including initiating COMFORT Toddlers and COMFORT Children, screening the last patient in VITESSE, and announcing top-line efficacy and safety data from year three of EPITOPE.
Positive Outlook
- Initiate COMFORT Toddlers, the six-month supplemental safety trial in support of BLA.
- Screen last patient in VITESSE, now expected by Q3 2024.
- Initiate COMFORT Children, the six-month supplemental safety trial in support of BLA.
- Announce top-line efficacy and safety data from year three of EPITOPE, corresponding to end-of-study results for participants completing three years of active treatment.
- Publish manuscripts including invited reviews in peer-reviewed scientific journals and submit abstracts on new data at upcoming scientific conferences.
Challenges Ahead
- The Company has incurred operating losses and negative cash flows from operations since inception.
- The Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months.
- There is substantial doubt regarding the Company’s ability to continue as a going concern.
- The Company intends to seek additional capital through debt and equity offerings.
- Uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals.