DBV Technologieswhich specializes in developing treatments for food allergies, said it would not have enough 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 flow since the company’s inception as the reason for the low cash reserves. The French biotech’s lead candidate, Viaskin Peanut allergy treatment, has so far failed to secure approval from US regulators.
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.” By warning its investors that the company cannot guarantee that it can secure financing on favorable terms, if it can secure financing at all. DBV Addition may be required to scale back its operations by delaying or reducing its research and development operations, or may waive the rights to its pipeline candidates if it is unable to secure financing.
DBV shares fell more than 8.17% during today’s (7 November) trading on the Euronext market. The company reported cash reserves of $46.4 million. as of September 30, which is $92.2 million. less than the cash available at the end of last year (December 31, 2023). DBV noted that the funds were mainly directed towards clinical trials for Viaskin Peanut.
In April 2023 The US Food and Drug Administration (FDA) said that although the DBV peanut allergy patch successfully met the primary endpoints in the phase III EPITOPE study (NCT03211247) in young children (one to three years of age), further safety study is needed for approval.
The approval process for the Viaskin patch was tumultuous. In 2017 the allergy pathway failed to meet its primary endpoint in the PEPITES phase III clinical trial (NCT02636699) in children aged 4-11 years. The company’s second trial of the phase III trial VITESSE (NCT05741476) in a narrower age group of 4-7 years failed when The FDA has placed a partial clinical hold on the survey in September 2022. The hold has since been lifted and the company expects to share key data from the study in Q4 2025.
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After a back-and-forth with the FDA, DBV plans to continue approval of Viaskin Peanut in toddlers in the U.S. and children ages one to seven in Europe. Last month, the company noted that as part of the accelerated approval path, the FDA is requesting additional safety data.
DBV plans to start additional safety studyCOMFORT Toddlers, evaluating Viaskin Peanut in approximately 250 toddlers in the second quarter of 2025. The company also plans to start COMFORT Children, a safety study in children aged four to seven years, in the second quarter of 2025. The trial is expected to include 250 participants.
Another candidate in DBV’s plans is a milk allergy treatment, DBV135 (Viaskin milk patch). The company evaluated the patch in children aged two to 17 years in the phase I/II MILES study (NCT02223182). DBV is also studying DVB135 as a treatment for the 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 diseases. However, these programs are in the preclinical stage.
