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PRE-MKT · 04:35 ET
Market ClerkRecap
Mon Oct 26 · pre-market1 signal on Oct 2494 insider buys this week · $48.3MCIRO short report next: Oct 31The week ahead

DBVTF

DBV Technologies S.A.
OTC · HEALTH CARE · BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
1.98
+0.00 +0.00%
USD · close Oct 23
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Work order
0
FLAG · shorts 0
Insiders, 90 days
0
no open-market filings in 90 days
Congress, 90 days
0 / 0
no disclosures naming it
Big money
0 / 15
none of the tracked funds disclose it
Calls on record
0
nobody we score has called it yet
MKT CAP $586.2MP/E —DIV YIELD —FCF YIELD -29.10%REV TTM $5M +29.3%NET INCOME −$176MNET CASH $174.4M52W 0.00 – 4.80SEC XBRL · TTM TO Invalid Date

How DBVTF rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
62%
of sentences unchanged
Added
239
new sentences
Dropped
223
sentences removed
Length
−122
words, now 36,363

New in FY2025

  • Risk Factors Investing in our securities involves a high degree of risk.
  • We have incurred net losses in each year since our inception in 2002, including net losses of $146.9 million and $113.9 million for the years ended December 31, 2025 and 2024 respectively.
  • As of December 31, 2025, we had an accumulated deficit of $1,553 million.
  • To date, we have financed our operations primarily through the sale of equity securities, obtaining public assistance in support of innovation, reimbursements of research tax credit claims and strategic collaborations.
  • To date, we have not generated any product revenue and we continue to advance the clinical and regulatory development of Viaskin Peanut in the United States and EU.
  • If the prevalence of peanut allergy is lower than we expect or declines, our revenue prospects will be smaller.
  • F - 35 We will require substantial additional funding, which may not be available on acceptable terms, or at all.
  • As of December 31, 2025, our cash and cash equivalents were $194.2 million and we received from the subsequent exercise of the ABSA and BS warrants, a total gross proceed of $94 million (€81 million).
  • The occurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
  • In addition, the combined shareholders’ meeting dated June 11, 2025 granted authority to our board of directors to increase our share capital up to 100% of issued share capital, if the investors in such offering fit within categories of persons meeting certain characteristics.
  • Government, including the FDA, has also experienced recent challenges in personnel staffing , which personnel shortages could adversely impact the review and responsiveness on INDs or BLAs.
  • Future pandemics, epidemics or other public health crises (collectively, “public health crises”) could have an impact on our ability to conduct clinical trials, and clinical site initiation, subject enrollment and subject visits (including food challenges) in any of our clinical trials may be suspended or F - 36 delayed due to prioritization of hospital resources toward responding to such public health crises.
  • Our business could be materially and adversely affected by the effects of future public health crises in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
  • It is impossible to predict all effects and the ultimate impact of public health crises.
  • Conflicts could disrupt our and our collaborators’ supply chains and adversely affect our and our collaborators’ ability to conduct ongoing and future clinical trials of our product candidates.
  • While we have established certain procedures and controls over our financial reporting processes, we cannot assure you that these efforts will prevent restatements of our financial statements in the future.
  • Depending on our future filer status with the SEC, our independent registered public accounting firm may also be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to report on the effectiveness of our internal control over financial reporting.
  • Our future capital requirements will depend on, and could increase significantly as a result of, many factors including: • the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials; • the approval of Viaskin Peanut by the FDA, European Commission, or other comparable regulatory authorities; • the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive regulatory approval, especially in North America; • the costs of securing manufacturing arrangements for commercial production; • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive regulatory approval; • the scope, prioritization and number of our research and development programs; • the costs, timing and outcome of regulatory review of our product candidates; • the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into; • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under our existing collaboration agreements and future collaboration agreements, if any; and F - 37 • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights.
  • We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements and other applicable securities rules and regulations.
  • Compliance with these rules and regulations will continue to increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources, particularly as we qualify as a domestic filer.
  • The Exchange Act requires that, we file annual, quarterly and current reports with respect to our business, financial condition and results of operations.
  • We are required to file proxy statements in connection with any meetings of our shareholders.
  • As a result of being a U.S. public company and the accompanying additional reporting requirements, management’s attention may be diverted from other business concerns, which could adversely affect our business and results of operations.
  • As a result of disclosure of information in filings required of a U.S. public company, our business and financial condition are more visible than they would be if we were a privately-owned company or if our securities were listed only on Euronext Paris, which we believe may result in threatened or actual litigation, including by competitors and other third parties.
  • F - 38 Risks Related to Product Development, Regulatory Approval and Commercialization We depend almost entirely on the successful development of our novel Viaskin technology.
  • We are currently conducting the OLE phase of VITESSE, a Phase 3 pivotal study in children aged 4 through 7 years of age.
  • Additionally, we are conducting the COMFORT Toddlers supplemental safety study in peanut allergic children 1 through 3 years of age using the Type IV Viaskin Peanut Epicutaneous System (the planned commercial Viaskin Peanut system in this age group, or cVP).
  • In connection with the Accelerated Approval pathway for Viaskin Peanut in toddlers 1-3-years-old we will need to complete a post-marketing confirmatory study to assess the effectiveness of the intended commercial Viaskin Peanut patch that will need to be initiated at the time that the BLA is submitted.
  • The confirmatory study must also be positive post-approval or the FDA may seek withdrawal of approval of Viaskin Peanut in the 1 - 3-year-old age group.
  • Our other product candidates are still in pre-clinical or early proof-of-concept phase development.
  • In addition, in some jurisdictions such as the EU, initiating Phase 3 clinical trials, including clinical trials in the pediatric population, is subject to a requirement to obtain approval from the competent authorities of the EU Member States.
  • For trials involving pediatric populations, sponsors must also have agreed on a Pediatric Investigation Plan (“PIP”) or a granted waiver/deferral.
  • Obtaining requisite regulatory approval in any country is a complex, lengthy, expensive and uncertain process, and the FDA or the applicable foreign regulatory authority may delay, limit or deny approval of a Viaskin product, for many reasons, including, among others: • we may not be able to demonstrate that a product candidate is a safe and effective treatment, to the satisfaction of the FDA or the applicable foreign regulatory authority; • the results of our clinical trials or the clinical trials conducted by third party academic institutions and included in our application package may not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory authority for regulatory approval; • the FDA or the applicable foreign regulatory authority may disagree with the number, design, size, conduct or implementation of our clinical trials; • the FDA or the applicable foreign regulatory authority may require that we conduct additional clinical trials; • the FDA or the applicable foreign regulatory authority may not approve the formulation, labeling or specifications of a product candidate; • the CROs that we retain to conduct our clinical trials may take actions outside of our control that materially adversely impact our clinical trials; • the FDA or the applicable foreign regulatory authority may find the data from pre-clinical studies and clinical trials from a product candidate insufficient to demonstrate that the clinical or other benefits of such product candidate outweighs its respective safety risks; • the FDA or the applicable foreign regulatory authority may disagree with our analysis or interpretation of data from our pre-clinical studies and clinical trials; • the FDA or the applicable foreign regulatory authority may not accept data generated at our clinical trial sites; • an advisory committee, or similar body, may recommend against approval of our application or may recommend that the FDA or the applicable foreign regulatory authority require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; • the FDA or the applicable foreign regulatory authority may require development or implementation of a REMS or comparable foreign requirements, as a condition of approval or post-approval; • the FDA or the applicable foreign regulatory authority may restrict the use of our products to a narrow population; • the FDA or the applicable foreign regulatory authority may not approve the manufacturing processes or facilities of our own or of third-party manufacturers with which we contract, or may issue inspectional findings that require significant expense and time to address; or • the FDA or the applicable foreign regulatory authority may change their approval policies or new legislation governing the approval processes.
  • F - 39 Our product candidates have undergone and/or will be required to undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure.
  • For example, in August 2020, we received a CRL in which the FDA indicated it could not approve the Viaskin Peanut BLA in its then-current form.
  • The FDA also indicated that supplementary clinical data would need to be generated to support applications for the Type IV Viaskin Peanut System , or cVP, and requested additional CMC data.
  • In many of our clinical trials, we utilize an oral food challenge procedure intentionally designed to trigger an allergic reaction, which could be severe or life-threatening.
  • The completion of trials for Viaskin Peanut and our other product candidates may be delayed for a variety of reasons, including, but not limited to, delays in: • demonstrating sufficient safety and efficacy to obtain regulatory approval to commence a clinical trial; F - 40 • reaching agreement on acceptable terms with prospective CROs and clinical trial sites; • validating test methods to support quality testing of the drug substance and drug product; • obtaining sufficient quantities of the drug substance or other materials necessary to conduct clinical trials; • manufacturing sufficient quantities of a product candidate; • obtaining timely responses from and permission to proceed from the FDA under an IND application, or foreign equivalent approval from regulatory authorities outside the United States; • obtaining IRB approval or positive Ethics Committee opinions as part of the single decision on the authorization of a clinical trial issued by EU Member States including input from the national competent authority and Ethics Committee, to conduct a clinical trial at a prospective clinical trial site; • determining dosing and clinical design and making related adjustments; and • subject enrollment, which is a function of many factors, including the size of the population, the nature of the protocol, the proximity of participants to clinical trial sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial.
  • Furthermore, if we fail to comply with applicable FDA and other regulatory requirements at any stage during this regulatory process, we may encounter or be subject to: • issuance of warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available; • diminishment of any competitive advantages that such product candidates may have or attain; • suspension, delays or termination in clinical trials or commercialization; • delays or refusal by the FDA or similar foreign regulatory authorities to review pending applications for regulatory approval or supplements to approved applications; • voluntary or mandatory product recalls or seizures; • refusal to permit the import or export of medicinal products or intermediary chemicals; F - 41 • suspension, restrictions or additional requirements on operations, including of manufacturing or revocation of necessary licenses; • withdrawals, variations or suspensions of regulatory approvals; and • fines, civil penalties, and criminal prosecutions.
  • With respect to marketing authorizations in the European Union, we will be required to submit an MAA to the EMA or the national competent authorities of EU Member States, which conduct a validation and scientific review process in evaluating a product for safety and efficacy.

and 199 more.

Gone since FY2024

  • Investing in our securities involves a high degree of risk.
  • We have incurred net losses in each year since our inception in 2002, including net losses of $113.9 million and $72.7 million for the years ended December 31, 2024 and 2023 respectively.
  • As of December 31, 2024, we had an accumulated deficit of $286.4 million.
  • To date, we have financed our operations primarily through the sale of equity securities, obtaining public assistance in support of innovation, such as conditional advances from OSEO Innovation, or OSEO, reimbursements of research tax credit claims and strategic collaborations.
  • To date, we have not generated any product revenue and we continue to advance the clinical and regulatory development of Viaskin Peanut in the United States and European Union.
  • The Company has incurred operating losses and negative cash flows from operations since inception.
  • Subsequent to December 31, 2024, the Company raised additional proceeds in a private placement financing (the “2025 PIPE”) consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7, 2025 for an amount of €38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares").
  • The Company received initial net proceeds of $125.5 million (€116.3 million) on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026.
  • We further estimate that, following the potential issuance of all Warrant Shares in the financing, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), we could extend our financial visibility into 2028 and through potential commercialization of Viaskin Peanut in the U.S, if approved.
  • We will require substantial additional funding, which may not be available on acceptable terms, or at all.
  • As of December 31, 2024, our cash and cash equivalents were $32.5 million.
  • Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $32.5 million as of December 31, 2024 will be sufficient to fund our operations into April 2025.
  • Subsequent to December 31, 2024, the Company raised additional proceeds in the 2025 PIPE of initial net proceeds of $125.5 million (€116.3 million) received on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026.
  • The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
  • In addition, the combined shareholders’ meeting dated May 16, 2024 granted authority to our board of directors to increase our share capital up to 100% of issued share capital, if the investors in such offering fit within categories of persons meeting certain characteristics.
  • Government, including the FDA, has also experienced recent challenges in personnel staffing related to the new administration, which personnel shortages could adversely impact the review and responsiveness on INDs or BLAs.
  • Future pandemics, epidemics or other public health crises (collectively, “public health crises”) could have an impact on our ability to conduct clinical trials, and clinical site initiation, subject enrollment and subject visits (including food challenges) in any of our clinical trials may be suspended or delayed due to prioritization of hospital resources toward responding to such public health crises.
  • Our business could be materially and adversely affected by the effects of any future public health crises in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
  • It is impossible to predict all effects and the ultimate impact of any public health crises.
  • On February 24, 2022, Russian forces launched significant military action against Ukraine, and sustained conflict and disruption in the region is possible.
  • The impact to Ukraine as well as actions taken by other countries, including new and stricter sanctions imposed by Canada, the United Kingdom, the European Union, the United States and other countries and companies and organizations against officials, individuals, regions, and industries in Russia and Ukraine, and actions taken by Russia in response to such sanctions, and responses of countries and political bodies to such sanctions, tensions, and military actions and the potential for more widespread conflict, have resulted in supply chain disruptions, and resulting increases in inflation, financial market volatility and capital markets disruption, potentially increasing in magnitude, and such effects on the global economy and financial markets could affect our business, operations, operating results and financial condition as well as the price of our common stock and our ability to raise additional capital when needed on acceptable terms.
  • Separately, in early October 2023, Hamas, a militant group in control of Gaza, and Israel began an armed conflict in Israel, the Gaza Strip, and surrounding areas, which threatens to spread to other Middle Eastern countries, including Lebanon, Syria, and Iran.
  • The Hamas-Israel military conflict is ongoing, and its length and outcome are highly unpredictable.
  • Any or all of the effects of these conflicts could disrupt our and our collaborators’ supply chains and adversely affect our and our collaborators’ ability to conduct ongoing and future clinical trials of our product candidates.
  • While we have established certain procedures and control over our financial reporting processes, we cannot assure you that these efforts will prevent restatements of our financial statements in the future.
  • Depending on our future filer status with the SEC, our independent registered public accounting firm may also require, pursuant to Section 404 of the Sarbanes-Oxley Act, to report on the effectiveness of our internal control over financial reporting.
  • Our future capital requirements will depend on, and could increase significantly as a result of, many factors including: • the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials; • the approval of Viaskin Peanut by the FDA, European Commission, or other comparable regulatory authorities; • the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive regulatory approval, especially in North America; • the costs of securing manufacturing arrangements for commercial production; • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive regulatory approval; • the scope, prioritization and number of our research and development programs; • the costs, timing and outcome of regulatory review of our product candidates; • the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into; • the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under our existing collaboration agreements and future collaboration agreements, if any; and • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights.
  • We are subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements and other applicable securities rules and regulations.
  • Compliance with these rules and regulations will continue to increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources, particularly as we now qualify as a domestic filer.
  • The Exchange Act requires that, as a public company that no longer qualifies as a foreign private issuer, we file annual, quarterly and current reports with respect to our business, financial condition and result of operations.
  • Because we are no longer a foreign private issuer, we will also be required to file proxy statements in connection with any meetings of our shareholders.
  • As a result of being a U.S. public company, management’s attention may be diverted from other business concerns, which could adversely affect our business and results of operations.
  • As a U.S. public company that is subject to these rules and regulations, we may find it is more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
  • These factors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and compensation committee, and qualified executive officers.
  • As a result of disclosure of information in filings required of a U.S. public company, particularly as we are no longer a foreign private issuer, our business and financial condition will become more visible than they would be if we were a privately-owned company or if our securities were listed only on Euronext Paris, which we believe may result in threatened or actual litigation, including by competitors and other third parties.
  • Risks Related to Product Development, Regulatory Approval and Commercialization We depend almost entirely on the successful development of our novel Viaskin technology.
  • We are currently conducting VITESSE, a Phase 3 pivotal study in children aged 4 through 7 years of age with confirmed diagnosis of peanut allergy with Type V Viaskin Peanut System, or the modified Viaskin Peanut system.
  • Additionally, we are planning one additional Phase 3 safety study in response to the FDA’s request regarding the size of the controlled safety database.
  • This safety study will be conducted in peanut allergic children 1 through 3 years of age using the Type IV Viaskin Peanut Epicutaneous System (the planned commercial Viaskin Peanut system in this age group, or cVP).
  • Lastly, in connection with the Accelerated Approval pathway for Viaskin Peanut in toddlers 1 – 3-years-old we will need to complete a post-marketing confirmatory study to assess the effectiveness of the intended commercial Viaskin Peanut patch that will need to be initiated at the time that the BLA is submitted.

and 183 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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