DBVT - DBV Technologies Reports First Quarter 2024 Financial Results and Business Update | Benzinga

Montrouge, France, May 7, 2024

DBV Technologies Reports First Quarter 2024 Financial Results and Business Update

• VITESSE enrollment on track to screen last patient by Q3 2024
• Appointment of Robert Pietrusko, PharmD to Chief Regulatory Officer
• Q1 2024 closes with a cash balance of $101.5 million
  
  

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the first quarter 2024. The quarterly financial statements were approved by the Board of Directors on May 7, 2024.

Recent Business Developments

Clinical and Regulatory Update
Enrollment for VITESSE, DBV's Phase 3 pivotal study of the modified Viaskin Peanut patch in children ages 4 through 7 years with peanut allergy passed the halfway point for recruitment in Q1 and continues to be on track to screen the last patient by Q3 2024. VITESSE is a trial evaluating efficacy and safety in approximately 600 subjects (randomized 2:1) with 86 participating sites in US, Canada, Europe, UK and Australia.

"We are pleased with VITESSE enrollment rates and thrilled that our sites in Europe and the UK are actively enrolling subjects and have increased the momentum for VITESSE," said Pharis Mohideen, M.D. Chief Medical Officer at DBV Technologies. "This comes on the heels of the February AAAAI meeting where there was tremendous interest in Viaskin Peanut and standing room only, record breaking attendance at our product theatre "Importance of Early Intervention for Peanut Allergy."

The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 through 3-year-olds to the FDA on November 9, 2023. The Company and the FDA are engaged in ongoing dialogue related to the program.

Appointment of Robert Pietrusko, Chief Regulatory Officer

DBV has strengthened its regulatory expertise by appointing Robert Pietrusko, PharmD, to the position of Chief Regulatory Officer. Bob brings a wealth of expertise to DBV through his more than four decades of biopharmaceutical regulatory experience.

Bob joins DBV from Vor Bio, where he has served as Chief Regulatory Officer since April 2020. He previously served as Senior Vice President of Regulatory Affairs & Quality Assurance at Voyager Therapeutics, Inc., and as Vice President of Global Regulatory Affairs and Quality at ViroPharma Incorporated (acquired by Shire in 2013). He has served in regulatory and quality assurance roles of increasing responsibility at Millennium Pharmaceuticals (acquired by Takeda in 2008) and SmithKline Beecham (part of GlaxoSmithKline).

Bob has led the regulatory effort leading to more than 35 BLA/NDA/MAA approvals globally including in the US across many FDA Divisions at both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). He is also a leader in regulatory policy through his involvement as Chair of the Regulatory Affairs Committee of the Alliance for Regenerative Medicine (ARM) and an appointed member of the Regulatory Affairs committee of the American Society of Gene and Cell Therapies (ASGCT).

"Bob brings to DBV extensive regulatory affairs and quality expertise, and his leadership is an important addition to the company," stated Daniel Tassé, Chief Executive Officer of DBV Technologies. "In addition to his deep understanding of complex development programs, he has a proven track record of shepherding multiple products through the regulatory process to approval across the various divisions of the FDA. Bob's guidance will be instrumental as we continue the development of Viaskin Peanut in toddlers and children. We are thrilled to welcome him to our team."

Financial Highlights for the First Quarter Ended March 31, 2024

The Company's interim condensed consolidated financial statements for the three months ended March 31, 2024, are prepared in accordance with accounting principles in the U.S. ("U.S. GAAP").

Cash and Cash Equivalents

Cash and cash equivalents amount to $101,5 million as of March 31, 2024, compared to $141,4 million as of December 31, 2023, a net decrease by $39,8 million including $34,7 million of net cash flow used in operating activities, mainly external clinical-related expenses explained by progress on patient enrollment in VITESSE Phase 3 clinical trial.

The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company's available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company's ability to continue as a going concern.

Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024, will be sufficient to fund our operations until December 31, 2024. The Company intends to seek additional capital as it continues research and development efforts and prepares for the launch of Viaskin Peanut, if approved.

Operating Income

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