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DBV Technologies Reports First Quarter 2024 Financial Results and Business UpdateMontrouge, France, May 7, 2024 DBV Technologies Reports First Quarter 2024 Financial Results and Business Update
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 “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
Operating income amounts to $1,4 million for the first 3 months ended March 31, 2024, compared with $2,2 million for the same period in 2023, a decrease by $0,8 million mainly resulting from the contract termination with Nestlé Health Science for $0,4 million. Operating Expenses
Net Loss and Net Loss Per Share
Net result for the first three months ended March 31, 2024, is a loss amounting to $27,3 million, compared to a loss amounting to $20,6 million for the first three months ended March 31, 2023. On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is $0,28 for the first three months ended March 31, 2024. CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
About DBV Technologies DBV Technologies is headquartered in Montrouge, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking Statements Viaskin and EPIT are trademarks of DBV Technologies. Investor Contact Media Contact Attachment |