DBV Technologies SA (DBVT, Financial), a clinical-stage biopharmaceutical company, announced its third-quarter 2023 financial results on October 31, 2023. The company also received written feedback from the U.S. Food and Drug Administration (FDA) regarding the remaining study design elements for the COMFORT supplemental safety studies.
Financial Highlights
The company's cash and cash equivalents amounted to $149.1 million as of September 30, 2023, compared to $209.2 million as of December 31, 2022. This represents a net decrease of $60.1 million, primarily due to operating activities.
Operating income for the nine months ended September 30, 2023, was $6.9 million, an increase of $0.8 million from the same period in 2022. However, operating expenses also increased by $6.6 million, amounting to $71.4 million for the nine months ended September 30, 2023.
The net loss for the nine months ended September 30, 2023, was $61.5 million, compared to a loss of $57.0 million for the same period in 2022. The net loss per share was $0.65 for the nine months ended September 30, 2023.
Business Developments
DBVT received feedback from the FDA on the protocol design elements for the COMFORT supplemental safety studies. The company plans to implement the FDA's feedback and expects to submit the final COMFORT Toddlers protocol design to the Agency in the coming weeks.
DBVT's Chief Medical Officer, Pharis Mohideen, expressed satisfaction with the FDA's feedback and confidence in the company's regulatory path forward. The company anticipates enrolling the first subject in Q1 2024.
On October 30, 2023, DBVT and Nestle Health Science agreed to terminate their Development, Collaboration and License Agreement, which aimed to develop a standardized atopy patch test tool for diagnosing Cow’s Milk Protein Allergy in infants and children.
DBV Technologies is developing Viaskinâ„¢, a proprietary technology platform with potential applications in immunotherapy. The company's food allergies programs include ongoing clinical trials of Viaskin Peanut.
Explore the complete 8-K earnings release (here) from DBV Technologies SA for further details.
