DBV Technologies S.A.
For the period ended Sep 30, 2026. Filed Oct 28, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Oct 28, 2026
DBVT$10.45+6.6%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-07-16.
0001628280-26-048453
Item 1A. Risk FactorsDefaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-10-28.
0001628280-26-067930
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of Proceeds Defaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 12 previous paragraphs and 15 current paragraphs.
8 unchanged; 4 reworded; 3 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
The current filing states there were no material changes to risk factors.
This is the filer’s own statement, not a conclusion from the comparison. Read its qualifications and the report it references.
Current filing’s statement
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report and in Part II, Item 1A of our Quarterly Report on Form 10-Q for the Quarter ended June 30, 2026. There have been no material changes in our risk factors from those disclosed in the Annual Report except as follows:
Added paragraphs (3)
Current report
There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Current report
Our unaudited condensed consolidated financial statements as of September 30, 2026 have been prepared assuming the Company will continue as a going concern for the next twelve months. Our management concluded that our recurring losses from operations, existing unrestricted cash, and cash equivalents raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements included in this Quarterly Report on Form 10-Q. As of September 30, 2026, we had unrestricted cash, cash equivalents and marketable securities of $165.7 million consisting of cash and investments. Subsequent to September 30, 2026, we raised additional proceeds of approximately $50 million total gross proceeds through the Company’s ATM Program. We do not expect our existing cash and cash equivalents will be sufficient to fund our operations through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time. Although management has been successful in raising capital in the past, there can be no assurance that we will be successful or that any needed financing will be available in the future at terms acceptable to us. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements included in this Quarterly Report on Form 10-Q and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
Current report
Since the FDA’s warning letters, FAREVA has confirmed that it has responded to the FDA in accordance with applicable regulatory timelines and provided monthly remediation updates.
Reworded paragraphs (4)
Previous wording
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. There have been no material changes in our risk factors from those disclosed in the Annual Report, aside from those disclosed below. While management has plans to address these issues, there is no assurance these plans will be successful, which could materially impact our business and financial condition.
Current wording
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report and in Part II, Item 1A of our Quarterly Report on Form 10-Q for the Quarter ended June 30, 2026. There have been no material changes in our risk factors from those disclosed in the Annual Report except as follows:
Previous wording
We also expect to rely on Sanofi and on FAREVA for the manufacturing of the patch and on other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other product for which we obtain regulatory approval. Sanofi may not be able to effectively scale its manufacturing capacity of our API to meet our commercialization needs and we may be unable to establish any agreements with other third-party manufacturers or to do so on acceptable terms. Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
Current wording
•We also expect to rely on Sanofi and on FAREVA for the manufacturing of the patch and on other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other product for which we obtain regulatory approval. Sanofi may not be able to effectively scale its manufacturing capacity of our API to meet our commercialization needs and we may be unable to establish any agreements with other third-party manufacturers or to do so on acceptable terms. Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:reliance on the third party for regulatory compliance and quality assurance;
Previous wording
We have been informed by FAREVA Amboise (“FAREVA”), our sole contract manufacturer for Viaskin Peanut patches, that the FDA has issued warning letters to FAREVA identifying certain current Good Manufacturing Practice (“cGMP”) deficiencies, including at the FAREVA facility at which our Viaskin Peanut patches are manufactured. We are working collaboratively with FAREVA on its remediation and mitigation efforts in response to these warning letters. If FAREVA is unable to remediate these deficiencies to the FDA's satisfaction in a timely manner, or if the FDA takes further enforcement action with respect to the FAREVA Amboise facility, our ability to manufacture Viaskin Peanut patches for our clinical trials or, if approved, for commercial supply could be materially and adversely affected. Because FAREVA is currently our sole manufacturer of Viaskin Peanut patches, we do not have an alternative manufacturing source to which we could readily transition, and any interruption or restriction on manufacturing at the FAREVA Amboise facility could significantly delay our clinical development and regulatory timelines, including timing of the filing, acceptance or approval of our anticipated BLA submission for the Viaskin Peanut patch in children ages 4 through 7 years, and could have a material adverse effect on our business, results of operations, and financial condition.
Current wording
We have been informed by FAREVA Amboise (“FAREVA”), our sole contract manufacturer for Viaskin Peanut patches, that the FDA has issued warning letters to FAREVA identifying certain current Good Manufacturing Practice (“cGMP”) deficiencies, including at the FAREVA facility at which our Viaskin Peanut patches are manufactured. We are working collaboratively with FAREVA on its ongoing remediation and mitigation efforts in response to these warning letters. If FAREVA is unable to remediate these deficiencies to the FDA's satisfaction in a timely manner, or if the FDA takes further enforcement action with respect to the FAREVA Amboise facility, our ability to manufacture Viaskin Peanut patches for our clinical trials or, if approved, for commercial supply could be materially and adversely affected. Because FAREVA is currently our sole manufacturer of Viaskin Peanut patches, we do not have an alternative manufacturing source to which we could readily transition, and any interruption or restriction on manufacturing at the FAREVA Amboise facility could significantly delay our clinical development and regulatory timelines, including timing of the filing, acceptance or approval of our anticipated BLA submission for the Viaskin Peanut patch in children ages 4 through 7 years, and could have a material adverse effect on our business, results of operations, and financial condition.
Previous wording
During the six months ended June 30,2026, none of our directors and officers (as defined in Rule16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trade arrangement” as those terms are defined in Item 408 of Regulations S-K.
Current wording
During the Three Months Ended September 30,2026, none of our directors and officers (as defined in Rule16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trade arrangement” as those terms are defined in Item 408 of Regulations S-K.