DBV Technologies reports $165.7 million in cash, warns of substantial doubt over going concern
Key Facts
DBV Technologies said it had $165.7 million in cash and cash equivalents as of September 30, 2026, but warned in its third-quarter results that this balance was not expected to be sufficient to fund operations for at least 12 months from the date the financial statements are issued. The company said substantial doubt exists about its ability to continue as a going concern during that period. At the same time, it said its funding estimate extends through the third quarter of 2027. The disclosure places the accounting warning alongside the funding outlook announced by the company, though each rests on a different framework. DBV also said it will need additional capital to fund its operations.
The company said the financing options it is considering include additional sales under its at-the-market offering program, equity transactions and warrant exercises, as well as other forms of financing. But it said the availability of these options when needed is not assured, and it cannot guarantee obtaining them on acceptable terms. DBV updated its $150 million at-the-market offering program during the third quarter. It also completed the sale of American depositary shares to RA Capital Management for a total of $50 million. These steps show funding sources the company has used or is considering, while the need for additional capital remains, according to its disclosure.
The company’s losses widened in the third quarter, with a net loss of $64.5 million compared with $33.2 million in the same period of 2025. For the nine months ended September 30, 2026, the loss reached $162.5 million, versus $102.1 million in the corresponding period of the previous year. Net cash used in operating and investing activities during the nine months was $159.4 million, up from $86.7 million a year earlier. The company attributed the increase in cash use to the advancement of activities and expansion of the organization. Research and development expenses also rose in the third quarter to $47.0 million from $28.6 million in the third quarter of 2025, which the company said reflected development activities and commercial readiness.
On the drug development front, DBV submitted a biologics license application to the U.S. Food and Drug Administration on September 29, 2026, for VIASKIN Peanut for children aged 4 to 7, and requested priority review. The application is based on the Phase 3 VITESSE trial, which included 654 children. The company expects the agency to determine in the fourth quarter of 2026 whether the application is complete for substantive review and to decide on the priority review request. The FDA says its goal is to take action within 6 months on priority applications, compared with 10 months for standard review. It also informs applicants of its decision on priority designation within 60 days of receiving the original application.
The company is simultaneously pursuing remediation measures at its contract manufacturer, Fareva, following an FDA warning letter in April 2026. DBV said the pre-approval inspection date was included in the application after the expected completion date for the remediation work. This comes as the company links higher research and development expenses to development activities and commercial readiness. The funding position, meanwhile, remains tied to the need for additional capital and to options the company said are not assured in terms of availability, timing or terms. It is expected to become clear in the fourth quarter of 2026 whether the treatment application is complete for substantive review and whether priority review will be granted.