Release Date: July 30, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- DBV Technologies SA (DBVT, Financial) has made significant progress in enrolling patients for the VITESSE Phase 3 pivotal trial for children aged four to seven years, with expectations to complete enrollment by the end of the third quarter.
- The company has extended its cash runway into the first quarter of 2025 due to effective cost-saving measures.
- DBV Technologies SA (DBVT) has submitted a draft labeling proposal to the FDA, informed by the EPITOPE pivotal data, to address concerns about patch wear time experience.
- The company has successfully published results from the Phase 3 EPITOPE study in the New England Journal of Medicine, demonstrating efficacy in toddlers aged one to three years.
- DBV Technologies SA (DBVT) has received positive momentum in its interactions with the FDA, with the agency indicating more bandwidth for non-COVID related product reviews.
Negative Points
- The company is still awaiting feedback from the FDA on the proposed labeling approach for Viaskin Peanut, which could delay progress.
- DBV Technologies SA (DBVT) reported a net loss of $60.5 million for the first half of 2024, highlighting financial challenges.
- Operating expenses increased by 28% compared to the previous year, driven by clinical and CMC activities, with a significant portion being non-recurring costs.
- The company is engaged in ongoing dialogue with the FDA regarding the COMFORT Toddlers supplemental safety study, which has not yet reached protocol alignment.
- There is uncertainty around the timeline for feedback and progress on the COMFORT Children study, as it is dependent on resolving issues with the COMFORT Toddlers study first.
Q & A Highlights
Q: Can you clarify what you mean by "patch wear time experience" in the context of the label-in, label-out approach?
A: The "patch wear time experience" refers to the duration and consistency with which children wear the patch. Some children wear it consistently for 24 hours, while others experience variability. This data helps identify which patients are likely to respond best to the treatment. (Daniel Tasse, CEO)
Q: Does the variability in patch wear time make it harder to quantify the treatment's effectiveness?
A: Not necessarily. We have extensive data that allows us to assess the overall experience and differentiate between patients who are likely to respond well and those who are not. This holistic approach provides a clear differentiation. (Pharis Mohideen, Chief Medical Officer)
Q: Can you define what constitutes a "robust clinical efficacy response" and the percentage of patients labeled in or out?
A: While specific numbers are not disclosed due to ongoing discussions with the FDA, the data set is robust, and there is a clear separation between label-in and label-out groups. The overall response rate is 67%, with label-in patients expected to have a higher response rate. (Daniel Tasse, CEO)
Q: Is there any update on the COMFORT Children study, and how does it relate to the COMFORT Toddlers study?
A: The two studies are interconnected. The focus is currently on finalizing the protocol for COMFORT Toddlers, which will inform the next steps for COMFORT Children. Agreement on the toddlers' protocol is the priority. (Daniel Tasse, CEO)
Q: What is the current status of your cash runway and financial management?
A: We closed the first half of 2024 with €66.2 million in cash, extending our runway into Q1 2025 due to cost-saving measures. Operating expenses increased by 28% due to clinical and CMC activities, with a third being non-recurring expenses. (Virginie Boucinha, CFO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
