DBV Technologies Q1 2024 Financial Results and Business Update

Montrouge, France, May 7, 2024 – DBV Technologies, a clinical-stage biopharmaceutical company specializing in treatments for food allergies and other immunologic conditions, has released its financial results for the first quarter of 2024. The company's Board of Directors approved the quarterly financial statements on May 7, 2024.

Recent Business Developments

Clinical and Regulatory Update

During the first quarter of 2024, DBV Technologies made significant progress with its VITESSE Phase 3 pivotal study. VITESSE is evaluating the modified Viaskin Peanut patch's efficacy and safety in children aged 4 to 7 years with peanut allergies. With over half of the recruitment completed, the trial remains on track to have the last patient screened by the third quarter of 2024. The study involves around 600 subjects across 86 sites in the US, Canada, Europe, the UK, and Australia.

Chief Medical Officer Pharis Mohideen, M.D., expressed satisfaction with the enrollment rates, particularly noting the active participation of sites in Europe and the UK. The Company also highlighted the increased interest in Viaskin Peanut, following notable attendance at the February AAAAI meeting.

Additionally, DBV Technologies has submitted its COMFORT Toddlers supplemental safety study protocol to the FDA. This study targets children aged 1 to 3 years, and the Company is in ongoing discussions with the FDA regarding this program.

Appointment of Robert Pietrusko as Chief Regulatory Officer

To bolster its regulatory expertise, DBV Technologies has appointed Robert Pietrusko, PharmD, as Chief Regulatory Officer. Pietrusko brings over 40 years of experience in biopharmaceutical regulatory affairs. He previously held senior regulatory roles at Vor Bio, Voyager Therapeutics, and ViroPharma Incorporated. His extensive experience includes leading regulatory efforts resulting in over 35 BLA/NDA/MAA approvals globally, including within various FDA divisions.

Daniel Tassé, CEO of DBV Technologies, emphasized Pietrusko's expertise and leadership, which are expected to be crucial as the company advances its Viaskin Peanut program for toddlers and children.

Financial Highlights for Q1 2024

DBV Technologies prepared its interim condensed consolidated financial statements for the quarter ending March 31, 2024, under U.S. GAAP.

Cash and Cash Equivalents

As of March 31, 2024, DBV Technologies reported cash and cash equivalents totaling $101.5 million, down from $141.4 million at the end of 2023. The $39.8 million decrease includes $34.7 million used in operating activities, mainly for clinical trial expenses related to the VITESSE Phase 3 study.

The company's ongoing operating losses and negative cash flows raise concerns about its ability to continue as a going concern. The current cash reserves are expected to fund operations until December 31, 2024, prompting the Company to seek additional capital for its continued research and development efforts and potential launch of Viaskin Peanut, pending approval.

Operating Income and Expenses

For the first three months ending March 31, 2024, DBV Technologies reported operating income of $1.4 million, down from $2.2 million in the same period of 2023. This decrease is mainly attributed to the termination of a contract with Nestlé Health Science.

Operating expenses for the first quarter totaled $30 million, up from $23.4 million in the previous year. This increase is primarily due to heightened research and development activities, notably the VITESSE Phase 3 clinical trial.

Net Loss

The net loss for the first quarter of 2024 was $27.3 million, compared to a loss of $20.6 million in the same period of 2023. The net loss per share was $0.28, based on the weighted average number of shares outstanding during the period.

About DBV Technologies

DBV Technologies is dedicated to developing treatment options for food allergies and other immunologic conditions with unmet medical needs. The company’s proprietary technology platform, Viaskin™, aims to introduce microgram amounts of a biologically active compound to the immune system through intact skin, leveraging the skin’s immune tolerizing properties. DBV Technologies is headquartered in Montrouge, France, with North American operations in Warren, NJ. The company’s shares are traded on Euronext Paris and the Nasdaq Global Select Market.

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