Full Press Release Details
DBV Technologies Receives Requested Feedback from FDA on
Protocol Design Elements for COMFORT Safety Studies and Reports Third Quarter 2023 Financial Results
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
| (in millions of USD) | U.S. GAAP | |||
| Nine months ended September 30, | ||||
| 2023 | 2022 | |||
| Net cash & cash equivalents at the beginning of the period | 209.2 | 77.3 | ||
| Net cash flow used in operating activities | (66.0) | (31.8) | ||
| Net cash flow provided by / (used in) investing activities | (0.6) | (0.1) | ||
| Net cash flow provided by / (used in) financing activities | 7.0 | 194.4 | ||
| Effect of exchange rate changes on cash & cash equivalents | (0.4) | (27.2) | ||
| Net cash & cash equivalents at the end of the period | 149.1 | 212.7 |
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:
| In millions of USD | U.S. GAAP | U.S. GAAP | ||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Research tax credits | 1.2 | 1.4 | 5.0 | 4.5 | ||||
| Other operating income | 1.1 | 0.7 | 1.9 | 1.7 | ||||
| Operating income | 2.4 | 2.1 | 6.9 | 6.1 |
Operating income amounts to $6.9 million for the nine months ended September 30, 2023, compared to $6.1 million for the
nine months ended September 30, 2022, which is an increase by $0.8 million due to:
On October 30th, 2023, Nestle Health Science and the Company agreed to terminate, as of the effective date of signature, the Development, Collaboration and License Agreement, which set out the terms for the
development of a standardized atopy patch test tool for the diagnosis of Cow s Milk Protein Allergy (non-IgE-mediated) in infants and children. Additionally, the parties agreed to end the APTITUDE study conducted as part of the collaboration
due to enrollment difficulties and not as a result of any safety issues.
| In millions of USD | U.S. GAAP | U.S. GAAP | ||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Research & Development | 13.8 | 15.1 | 47.4 | 45.9 | ||||
| Sales & Marketing | 0.7 | 0.2 | 1.6 | 1.7 | ||||
| General & Administrative | 6.2 | 4.8 | 22.3 | 17.2 | ||||
| Operating expenses | 20.6 | 20.1 | 71.4 | 64.8 |
Operating expenses amount to $71.4 million for the nine months ended September 30, 2023, compared to $64.8 million for
the nine months ended September 30, 2022, which is an increase by $6.6 million mainly due to:
Net Loss and Net Loss Per Share
| U.S. GAAP | U.S. GAAP | |||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Net income / (loss) (in millions of USD) | (16.7) | (17.3) | (61.5) | (57.0) | ||||
| Basic / diluted net income / (loss) per share (USD/share) | (0.17) | (0.18) | (0.65) | (0.79) |
Net result for the nine months ended September 30, 2023, is a loss amounting to $61.5 million, compared to a
loss amounting to $57.0 million for the nine months ended September 30, 2022.
On a per share basis, net loss (based on the weighted
average number of shares outstanding over the period) is $0.65 for the nine months ended September 30, 2023.
DBV will host a conference call and live audio webcast on Tuesday, October 31st, at 5:00 p.m. ET to report third quarter 2023 financial results and provide a business update.
Participants may access this call via the below teleconferencing numbers and asking to join the DBV Technologies call:
A live webcast of the call will be available on the Investors & Media section of the Company s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available
on DBV s website after the event.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
| In millions of USD | U.S. GAAP | |||
| September 30, 2023 | December 31, 2022 | |||
| Assets | 189.8 | 246.5 | ||
| of which cash & cash equivalents | 149.1 | 209.2 | ||
| Liabilities | 45.8 | 52.1 | ||
| Shareholders equity | 144.0 | 194.5 | ||
| of which net result | (61.5) | (96.3) |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
| In millions of USD | U.S. GAAP | U.S. GAAP | ||||||
| Three months ended September 30, | Nine months ended September 30, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Revenues | 2.4 | 2.1 | 6.9 | 6.1 | ||||
| Research & Development | (13.8) | (15.1) | (47.4) | (45.9) |
| Sales & Marketing | (0.7) | (0.2) | (1.6) | (1.7) | ||||
| General & Administrative | (6.2) | (4.8) | (22.3) | (17.2) | ||||
| Operating expenses | (20.6) | (20.1) | (71.4) | (64.8) | ||||
| Financial income/(expenses) | 1.5 | 0.7 | 3.0 | 1.7 | ||||
| Income tax | - | - | 0.0 | (0.1) | ||||
| Net loss | (16.7) | (17.3) | (61.5) | (57.0) | ||||
| Basic/diluted net loss per share attributable to shareholders | (0.17) | (0.18) | (0.65) | (0.79) |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW (unaudited)
| In millions of USD | U.S. GAAP | |||
| Nine months ended September 30, | ||||
| 2023 | 2022 | |||
| Net cash flows provided / (used) in operating activities | (66.0) | (32.0) | ||
| Net cash flows provided / (used) in investing activities | (0.6) | (0.1) | ||
| Net cash flows provided / (used) in financing activities | 7.0 | 194.4 | ||
| Effect of exchange rate changes on cash & cash equivalents (U.S. GAAP presentation) | (0.4) | (27.2) | ||
| Net increase / (decrease) in cash & cash equivalents | (60.1) | 135.4 | ||
| Net cash & cash equivalents at the beginning of the period | 209.2 | 77.3 | ||
| Net cash & cash equivalents at the end of the period | 149.1 | 212.7 |
About DBV Technologies
DBV Technologies is developing Viaskin , an investigational proprietary technology platform
with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT , and is DBV Technologies method of delivering biologically active compounds
to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies food
allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, 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).
Forward Looking Statements
press release may contain forward-looking statements and estimates, including statements regarding DBV s forecast of its cash runway, designs of DBV s anticipated clinical trials, DBV s planned regulatory and clinical efforts
including timing and results of communications with regulatory agencies, and the ability of any of DBV s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are
not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from
those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV s ability to successfully execute on its budget discipline
measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV s regulatory filings with
the French Autorit des March s Financiers ( AMF ), DBV s filings and reports with the U.S. Securities and Exchange Commission ( SEC ), including in DBV s Annual Report on Form 10-K for the year ended
December 31, 2022, filed with the SEC on March 2, 2023, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and
estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.
Viaskin and EPIT are trademarks of DBV