DBVT - DBV Technologies Receives Requested Feedback from FDA on Protocol Design Elements for COMFORT Safety Studies and Reports Third Quarter 2023 Financial Results | Benzinga

Montrouge, France, October 31, 2023

DBV Technologies Receives Requested Feedback from FDA on Protocol Design Elements for COMFORT Safety Studies and Reports Third Quarter 2023 Financial Results

• DBV has received written feedback from the U.S. Food and Drug Administration (FDA) clarifying design elements for both the COMFORT Toddlers and COMFORT Children supplemental safety studies.
• Both supplemental safety studies will have harmonized, simplified protocol language on how the product should be used.  
• The COMFORT Toddlers study will apply the same eligibility criteria as EPITOPE, DBV's successful Phase 3 efficacy study in toddlers 1-3 years.
• DBV will submit the final protocol for COMFORT Toddlers to FDA expeditiously and anticipates the first subject enrolled in Q1 2024.
• DBV closes Q3 2023 with a cash balance of $149 million.
• The Company will host a conference call and live audio webcast on Tuesday, October 31^st at 5:00pm.

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the receipt of written feedback from the U.S. Food and Drug Administration (FDA) regarding the remaining study design elements for the COMFORT (Characterization of the Optimal Management of FOod Allergy Relief and Treatment) supplemental safety studies. The Company also reported financial results for the third quarter of 2023. The quarterly financial statements were approved by the Board of Directors on October 31, 2023.

Recent Business Developments

Following DBV's request for clarification after receipt of Type C Meeting feedback in July 2023, the FDA provided Written Responses on protocol design elements for the COMFORT supplemental safety studies. Both COMFORT Toddlers and COMFORT Children protocol will have harmonized language guiding how the product will be used in the trials, such as, "Each DBV712 250 ?g epicutaneous system is intended to be worn for a full day (24 hours)." These instructions are simpler and more concise relative to previously used protocol language.

Further to this approach, both supplemental safety studies will seek to enroll populations that are closely aligned with their respective Phase 3 efficacy studies, as is feasible. For COMFORT Toddlers, eligibility criteria will be the same as in EPITOPE (Phase 3 efficacy study in 1-3-year-olds) as reliance on peanut specific-IgE and skin prick test alone does not ensure a Regulatory-level of assurance of peanut allergy or a similar peanut allergic patient population relative to EPITOPE. Thus, COMFORT Toddlers will include a double-blind, placebo-controlled food challenge (DBPCFC) as part of the Inclusion criteria.

For COMFORT Children, key inclusion criteria will remain peanut specific-IgE and skin prick test as these criteria are well established from previously conducted DBV studies (PEPITES and REALISE), as well as from the medical literature, and are expected to support enrollment of a similar study population relative to VITESSE (Phase 3 efficacy study in 4-7-year-olds). Therefore, a DBPCFC will not be required for COMFORT Children.

The size and duration of both supplemental safety studies remains unchanged from previous communications. These protocol design elements ensure closer alignment between the supplemental safety studies and their respective efficacy studies, which should ultimately support a more robust future BLA submission package for each indication.

"We are very pleased with the engagement and clarity of the feedback received from the FDA," stated Pharis Mohideen, Chief Medical Officer of DBV Technologies. "With a clear regulatory path forward, we will submit to FDA the final protocols for the COMFORT studies. We remain confident that this work will support a Biologics License Application (BLA) in both age groups and potentially bring this novel, much needed therapy to a vulnerable patient population."


DBV will implement the FDA's feedback and expects to submit the final COMFORT Toddlers protocol design to the Agency in the coming weeks. DBV anticipates the first subject will be enrolled in Q1 2024. The initiation of COMFORT Children is expected after the start of COMFORT Toddlers and in alignment with VITESSE recruitment.

Financial Highlights for the Third Quarter and the Nine Months Ended September 30, 2023

The Company's interim consolidated financial statements for the nine months ended September 30, 2023, are prepared in accordance with accounting principles in the U.S. ("U.S. GAAP"). Unless otherwise indicated, the financial figures presented in the Q3 Financial Highlights comply with U.S. GAAP consolidated financial statements. The financial figures are commented for the nine months ended September 30, 2023, under U.S. GAAP.

Cash and Cash Equivalents

Cash and cash equivalents amount to $149.1 million as of September 30, 2023, compared to $209.2 million as of December 31, 2022, which is a net decrease by $60.1 million mainly due to the following:

(1)   $66.0 million of cash used for operations, mainly driven by the initiation of the VITESSE trial with the first patient screened in March 2023.


Cash used for operations in the nine months ended September 30, 2023, increased by $34.2 million compared to the nine months ended September 30, 2022. The Company received 24.8 million euros (corresponding to $28.1 million on the basis of 2021 closing exchange rate) during the nine months ended September 30, 2022, for reimbursement of 2019, 2020, and 2021 French research tax credits.

(2)   $7.0 million net proceeds from the issuance and sale of new ordinary shares in the form of American Depositary Shares ("ADSs") on June 16, 2023, and pursuant to the At-The-Market ("ATM") program established in May 2022.


Cash provided by financing activities decreased by $187.4 million in the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022. The Company issued and sold new ordinary shares in the form of ADSs for a total gross amount of $7.8 million in June 2023 compared to $15.3 million in May 2022, and completed a private placement financing ("PIPE") amounting to a total gross amount of $194.0 million in June 2022.

(3)   $0.4 million negative impact of changes in exchange rates. The Company's treasury position, stated in U.S. Dollars, has been impacted by an appreciation of Euro against U.S. Dollar during the nine months ended September 30, 2023.


Operating Income

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