DBV Technologies (DBV) Q2 2024 earnings summary

Executive summary

• Viaskin Peanut, an epicutaneous immunotherapy patch, is in late-stage development for peanut-allergic children aged one to seven, with two parallel product candidates targeting toddlers (1–3 years) and children (4–7 years), addressing a significant unmet need.

• Two pivotal programs are ongoing: VITESSE Phase 3 trial in children aged 4–7 (modified patch) and EPITOPE/COMFORT studies in toddlers aged 1–3 (original patch), with VITESSE enrollment expected to complete by end of Q3 2024.

• Regulatory progress includes ongoing dialogue with the FDA on supplemental safety studies, a proposed labeling approach based on patch wear time, and increased agency engagement as non-COVID backlogs clear.

• Terminated collaboration with Nestlé Health Science in October 2023; all operating income now derives from research tax credits.

• Cost-saving measures have extended the cash runway into Q1 2025, but substantial doubt exists about the ability to continue as a going concern without additional capital.

Financial highlights

• Cash and cash equivalents at June 30, 2024, were $66.2 million, down from $141.4 million at December 31, 2023.

• Net loss for H1 2024 was $60.5 million, compared to $44.8 million in H1 2023; net loss per share was $0.63 versus $0.48.

• Operating income for H1 2024 was $2.6 million, mainly from research tax credits, down from $4.5 million year-over-year.

• Operating expenses rose to $65 million for H1 2024, up 28% year-over-year, driven by clinical, CMC activities, and increased headcount; one-third were non-recurring.

• Net cash used in operating activities was $69.8 million for H1 2024, mainly due to clinical trial expenses.

Outlook and guidance

• Cash runway is projected to last into Q1 2025, but ability to secure additional funding remains uncertain; plans to seek further funding through equity, debt, collaborations, or licensing.

• VITESSE trial enrollment expected to complete by end of Q3 2024, with top-line results anticipated 12 months after last patient screened.

• Awaiting FDA feedback on supplemental safety studies and proposed labeling for Viaskin Peanut in toddlers; study preparations continue.

• Year three results from the EPITOPE open-label extension and publication of year two results expected later in 2024.