Earnings call: DBV Technologies outlines Q3 financial results and regulatory updates for Viaskin Peanut programs

DBV Technologies has provided a comprehensive update on its financial results for the third quarter of 2023 and the status of its Viaskin Peanut programs during an earnings call. The company is developing two separate Viaskin Peanut programs for children aged 1-3 and 4-7, respectively, both of which are expected to support distinct Biologics License Applications (BLAs). Key takeaways from the call include:

• The company has received feedback from the FDA on the protocol design for its two pending supplemental safety studies, COMFORT Toddlers and COMFORT Children.

• The FDA has clarified certain protocol design elements, and DBV Technologies is now preparing to submit the safety protocol for COMFORT Toddlers.

• Enrollment for COMFORT Toddlers is expected to begin in the first quarter of 2024, with COMFORT Children to follow.

• The company's cash and cash equivalents as of September 30, 2023, stood at $149.1 million.

DBV Technologies' CEO, Daniel Tassé, and Chief Medical Officer, Dr. Pharis Mohideen, provided a detailed business update on the two Viaskin Peanut programs. The Viaskin Peanut programs aim to improve the lives of patients with food allergies. The company has completed its pre-BLA meeting for toddlers aged 1-3 and confirmed that the Phase III EPITOPE study met the prespecified criteria for success for the primary endpoint. The FDA requested a supplemental safety study to increase the total number of subjects on active treatment to approximately 600 per regulatory guidelines. For the 4-7 year-old indication, a supplemental safety study will also be conducted to increase the number of subjects on treatment with the modified circular patch to approximately 600 subjects. DBV Technologies plans to submit the finalized COMFORT Toddlers protocol in the next few weeks and anticipates initiating the COMFORT Toddlers study in the first quarter of 2024. The successful completion of this study would be a significant step towards filing a BLA for marketing approval in the U.S. Financially, the company's cash and cash equivalents as of September 30, 2023, were $149.1 million, a net decrease of $60.1 million from December 31, 2022. The decrease was mainly due to $66 million of cash used in operating activities, mainly driven by clinical work and the initiation of the VITESSE trial.

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