DBV Technologies shares fell 8% after the French biotech company warned of substantial doubt about its ability to continue operating for at least twelve months, despite holding $165.7 million in cash as of Sept. 30.
The company posted a third-quarter net loss of $64.5 million, more than double the $33.2 million loss from the same period a year earlier. R&D spending jumped to $47 million from $28.6 million, driven by $4.7 million in FDA application filing fees and $4.5 million for launch preparation and inventory. Sales and marketing costs climbed to $5.3 million from $1.2 million.
DBV management concluded that cash would not be sufficient to fund operations for at least twelve months, prompting the going-concern warning. The company said it will seek more capital through its ATM program, equity transactions, warrant exercises, and other financing options, with no assurance any will succeed on acceptable terms.
For the first nine months of the year, DBV posted a net loss of $162.5 million versus $102.1 million a year earlier. Net cash used in operating and investing activities was $159.4 million compared to $86.7 million in the prior period.
DBV filed its FDA application for Viaskin Peanut Patch on Sept. 29 for children aged 4 through 7 and requested priority review. The FDA is expected to decide in the fourth quarter whether the filing is complete enough to begin full review. The company plans a separate application for children aged 1 through 3 in 2027. The FDA issued a warning letter in April 2026 to Fareva Amboise, DBV's contract manufacturer, and the target date for the FDA's pre-approval inspection falls after when Fareva expects to complete remediation.
DBV refreshed its $150 million ATM program and raised $50 million in gross proceeds by selling shares to RA Capital Management.