DBV Technologies, which specialises in developing treatments for food allergies, has said that it will not have sufficient cash reserves to fund operations for “at least the next 12 months”.
Noted as part of its third quarter (Q3) earnings report, the company cited operating losses and negative cash flows since the company’s inception as the reason for the low cash reserves. The French biotech’s lead candidate, peanut allergy treatment Viaskin Peanut, has till date failed to secure US regulatory approval.
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DBV noted that it intends to “seek additional capital as it continues research and development (R&D) efforts and prepares for the launch of Viaskin Peanut if approved.” While cautioning its investors that the company could not guarantee that it could secure financing at favourable terms, if at all. Adding DBV may need to scale back operations, by delaying or reducing its R&D operations, or may relinquish the rights to its pipeline candidates, if it fails to secure financing.
DBV’s stock dropped by more than 8.17% in trading today (7 November) on the Euronext market. The company reported cash reserves of $46.4m as of 30 September, down by $92.2m from the cash on hand it had at the end of last year (31 December 2023). DBV noted that the funds were primarily directed towards clinical trial activity for Viaskin Peanut.
In April 2023, the US Food and Drug Administration (FDA) stated that although DBV’s peanut allergy patch successfully met the primary endpoints in the Phase III EPITOPE trial (NCT03211247) in toddlers (aged one to three years), an additional safety study is required for approval.
The Viaskin patch’s approval process has been a tumultuous one. In 2017, the allergy path failed to meet its primary endpoint in the Phase III PEPITES clinical trial (NCT02636699) in children aged 4-11 years. The company’s second attempt at Phase III VITESSE trial (NCT05741476) in a more narrowed age group of 4-7 years suffered a setback when the FDA placed a partial clinical hold on the study in September 2022. The hold has since been lifted and the company expects to share topline data from the study in Q4 2025.
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By GlobalDataFollowing the back and forth with the FDA, DBV plans to pursue Viaskin Peanut’s approval in toddlers in the US and children aged one to seven years in Europe. LAst month, the company noted that as part of the accelerated approval pathway, the FDA requires additional safety data.
DBV plans to start an additional safety study, COMFORT Toddlers, evaluating Viaskin Peanut in approximately 250 toddlers in Q2 2025. The company also plans to start a COMFORT Children, a safety study in four-to-seven-year-olds in Q2 2025. The trial is expected to enrol 250 participants.
Another candidate in DBV’s pipeline is a milk allergy treatment, DBV135 (Viaskin milk patch). The company evaluated the patch in children aged two to 17 years in a Phase I/II MILES trial (NCT02223182). DBV is also investigating DVB135 as a treatment for an allergic inflammatory condition, eosinophilic esophagitis.
DBV has also stated its intention to expand beyond food allergy therapies into vaccines and treatments for autoimmune and inflammatory disorders. However, these programmes are in the preclinical stage.
