DBV Technologies Announces Q3 2024 Financial Results

Châtillon, France, November 6, 2024 – DBV Technologies, a clinical-stage biopharmaceutical company, has announced its financial results for the third quarter of 2024. The quarterly and nine-month financial statements were approved by the Board of Directors on November 6, 2024.

As of September 30, 2024, DBV Technologies had a cash balance of $46.4 million, a significant decrease from the $141.4 million recorded at the end of 2023. The $95 million reduction in cash includes $92.2 million in operating activities, primarily due to expenses related to external clinical trials, particularly the VITESSE Phase 3 clinical trial, and other regulatory and manufacturing activities. The company has been operating with losses and negative cash flows since its inception, and the current cash reserves are projected to support operations only into the first quarter of 2025. As a result, there is considerable doubt about DBV's ability to continue as a going concern without securing additional capital.

DBV Technologies plans to seek further funding to continue its research and development efforts and to prepare for the potential launch of Viaskin Peanut, pending regulatory approval. However, the company acknowledges that obtaining necessary financing under favorable conditions may be challenging, especially due to potential disruptions in the global financial markets.

The interim condensed consolidated financial statements for the nine months ended September 30, 2024, show that DBV's operating income for the period was $3.6 million, down from $6.9 million in the same period in 2023. This decline is attributed to the termination of the Collaboration Agreement with NESTEC, which reduced income by $1.9 million, and a lower entitlement from the French Research Tax Credit due to more studies being conducted in North America.

Operating expenses increased significantly, amounting to $96.4 million for the nine months ended September 30, 2024, compared to $71.4 million for the same period in 2023. This rise is mainly due to a $23 million increase in research and development expenses driven by patient enrollment in the VITESSE Phase 3 clinical trial and preparatory activities for the COMFORT studies. General and administrative expenses also saw an increase of $1.4 million, primarily due to one-time costs associated with office relocations in France and the U.S., financing activities, and trademark and patent activities.

The net loss for the nine months ended September 30, 2024, was $90.9 million, compared to $61.5 million in the same period in 2023. On a per-share basis, the net loss was $0.95 for the nine-month period in 2024.

The financial position as of September 30, 2024, shows total assets of $93.1 million, with cash and cash equivalents comprising $46.4 million. Liabilities were reported at $39.0 million, and shareholders' equity stood at $54.0 million.

DBV Technologies is focused on developing treatment options for food allergies and other immunologic conditions using its proprietary technology platform, Viaskin. The Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin, utilizing epicutaneous immunotherapy (EPIT). This non-invasive treatment aims to desensitize individuals to allergens through the skin's immune tolerizing properties. The company's current focus is on clinical trials of Viaskin Peanut for peanut-allergic toddlers and children.

Headquartered in Châtillon, France, DBV Technologies also has operations in Warren, NJ. The company's shares are traded on Euronext Paris and the Nasdaq Capital Select Market.