On November 3, 2022 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the third quarter of 2022 (Press release, DBV Technologies, NOV 3, 2022, View Source [SID1234622985]). The quarterly financial statements were approved by the Board of Directors on November 3, 2022. The Company also announced recent business updates concerning the VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 study.
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DBV continues to engage with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE Phase 3 study protocol in children ages 4 to 7 years with a confirmed peanut allergy. The Company reports that progress has been made to address key elements of the partial clinical hold letter, but it will not meet the targeted first patient screened by year-end 2022. In parallel, DBV continues internal preparations for VITESSE and is conducting certain site assessment and start-up activities for prompt study launch once the partial clinical hold is lifted.
It is currently premature to assess the impact of the partial clinical hold letter on other previously announced milestones related to the VITESSE Phase 3 study. DBV will communicate additional updates publicly as appropriate, including once the partial clinical hold has been lifted. The Company plans to host a conference call following that announcement.
VITESSE is a Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years.
Financial Highlights for the Third Quarter and the Nine Months Ended September 30, 20221
Cash and cash equivalents were $212.7 million, as of September 30, 2022, compared to $77.3 million as of December 31, 2021, and $98.2 million as of September 30, 2021. The net increase of $135.4 million for the nine months ended September 30, 2022, was mostly comprised of a $194.7 million net cash flow received from the ATM Offering in May 2022 for $14.1 million; net of transaction costs and PIPE Offering in June 2022 for $180.6 million; net of transaction costs as well as a $26.4 million cash flow received following the reimbursement of the 2019, 2020 and 2021 Research Tax Credit (French Crédit Impôt Recherche, or CIR) offset by a $(58.2) million cash utilization in operating activities; and the effect of exchange rates on cash and cash equivalents for $(27.2) million.
Excluding the effect of reimbursement of the Research Tax Credit, the cash used in operating activities decreased by 35% between the nine months ended September 30, 2021 and September 30, 2022, respectively, reflecting the Company’s continued implementation of budget discipline measures.
Operating Income is primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science. Operating income was $6.1 million for the nine months ended September 30, 2022, compared to $2.8 million for the nine months ended September 30, 2021. The variation in operating income is primarily attributable to the revision of the revenue recognized under Nestlé’s collaboration agreement conducted as part of the existing contract, as the Company updated the measurement of progress of its Phase 2 APTITUDE milk-diagnostic tool clinical study.
Operating Expenses for the three months ended September 30, 2022, were $(20.1) million, compared to $(25.7) million for the three months ended September 30, 2021, or -22%. For the nine months ended September 30, 2022, operating expenses were $(64.8) million compared to $(87.9) million for the nine months ended September 30, 2021, or -26%. DBV has continued to practice financial diligence and implemented further cost containment strategies to support its clinical trial objectives.
Employee-related costs decreased by $6.1 million, from $23.1 million for the nine months ended September 30, 2021, to $17.0 million for the nine months ended September 30, 2022 – a 26% decrease, compared to a 24% decrease of the average number of headcounts between the two periods (85 and 105 full-time equivalent employees for the nine months ended September 30, 2022, and 2021, respectively). As of September 30, 2022, DBV had 83 employees.
For the three and nine months ended September 30, 2022, net loss was $(17.3) million and $(57.0) million, respectively, compared to a net loss of $(24.0) million and $(84.1) million, respectively, for the comparable periods in 2021. On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.18) and $(0.79) for the three and nine months ended September 30, 2022, respectively.
Conference Call Information
DBV will host a conference call and live audio webcast on Thursday, November 3, 2022, at 5:00 p.m. ET to report third quarter 2022 financial results and provide a business update.
This call is accessible via the below teleconferencing numbers, followed by the reference ID: 94309191#
A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event.