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Investor releaseQuarter not tagged2026-07-16DBV Technologies Reports Second Quarter and Half-Year 2026 Financial Results and Business Update
GlobeNewswire
DBV Technologies Reports Second Quarter and Half-Year 2026 Financial Results and Business Update
Châtillon, France, July 16, 2026 DBV Technologies Reports Second Quarter and Half-Year 2026 Financial Results and Business Update Continued productive engagement with the FDA in support of the BLA for the VIASKIN® Peanut Patch in children aged 4 through 7 years, with submission of the BLA anticipated in the third quarter of 2026 Reported cash and cash equivalents of $174.9 million as of June 30, 2026, funding into third quarter of 2027 DBV will host a conference call today, July 16, at 5:00pm ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a late-stage biopharmaceutical company, today reported financial results for the Second Quarter and Half-Year of 2026. The quarterly and Half-Year financial statements were approved by the Board of Directors on July 16, 2026. “2026 is an important year for DBV as we continue to prepare to become a commercial company, if approved. I’m happy to report that we have made meaningful progress towards that goal in the first half of the year,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “Recently, we shared the regulatory progress we’ve made through collaborative engagement with the FDA. We have also made judicious investments in launch readiness, while we continue to execute clinical studies that we expect will add further understanding to the potentially transformative value of the VIASKIN® Peanut Patch.” Half-Year 2026 Operational HighlightsRegulatory and Clinical Execution Continued advancing the BLA submission for the VIASKIN® Peanut Patch in children aged 4 through 7 years. Engaged in detailed and iterative discussions with the U.S. Food and Drug Administration (FDA) to support a complete, efficient and timely review of the BLA, once submitted. The FDA has not requested additional data. DBV is incorporating valuable, actionable feedback from the FDA specific to the organization, mapping and formatting of existing CMC and biostatistical data sets, and now anticipates submitting the BLA in the third quarter of 2026. Recruitment was closed in the second quarter of 2026 for the COMFORT Toddlers supplemental safety study, an important operational milestone in the continued advancement of the VIASKIN® Peanut Patch in toddlers aged 1 through 3 years. Initiated the THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad...
Investor releaseQuarter not tagged2026-07-16DBV Technologies Q2 Earnings Call Highlights
MarketBeat
DBV Technologies Q2 Earnings Call Highlights
Interested in DBV Technologies S.A.? Here are five stocks we like better. DBV Technologies is preparing to file a BLA for its VIASKIN Peanut Patch in Q3 2026 and said it may request priority review, with the FDA process still on track and no request for additional clinical data. The company is expanding its peanut allergy program beyond children ages 4 to 7, with recruitment closed for the COMFORT Toddlers safety study, a planned filing for ages 1 to 3 by year-end 2026, and the first infant patient enrolled in the new THRIVE Phase 2 study. DBV is also building commercial readiness for a potential U.S. launch, including market access, patient services, supply chain, and launch operations, and said it has funding into Q3 2027. 3 Biopharmaceutical Stocks Bucking the Sell-Off DBV Technologies (NASDAQ:DBVT) said it is continuing preparations for a planned third-quarter 2026 Biologics License Application submission for its VIASKIN Peanut Patch in children ages 4 through 7, while also building commercial infrastructure ahead of a potential U.S. launch. On a conference call discussing second-quarter and first-half 2026 results, Chief Executive Officer Daniel Tassé said the company is working to “transform the company into a commercial organization” in anticipation of possible FDA approval of the patch. The company’s lead program is aimed at treating peanut allergy in children. → 3 Space Stocks That Could Outshine SpaceX After Its IPO Tassé said DBV is still optimizing its BLA submission through discussions with the FDA, which he characterized as constructive and collaborative. He emphasized that the agency has not asked for additional data. “The work underway is focused on incorporating FDA feedback related to the organization, the mapping, and formatting of existing CMC and biostatistical data sets,” Tassé said. He added that DBV plans to submit an “optimized BLA” in the third quarter of 2026 to support an efficient review. → These 3 Water ETFs Could be Quiet Winners From Infrastructure Spending During the question-and-answer portion of the call, Tassé said DBV plans to request priority review when it files the BLA because the VIASKIN Peanut platform has breakthrough designation, making the company eligible to seek that review pathway. He said the FDA has up to 60 days after filing to accept the application for review and to determine whether priority review will b...
TranscriptFY2026 Q22026-07-16FY2026 Q2 earnings call transcript
Earnings source - 82 paragraphs
FY2026 Q2 earnings call transcript
Please note this event is being recorded. I would now like to turn the conference over to Jonathan Neely, Investor Relations. Please go ahead, sir.
Thank you. This afternoon, DBV Technologies reported financial results for the second quarter and half year of 2026. This update is available in the press releases section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements, including but not limited to comments regarding our forecast of estimated cash runway, clinical and regulatory development plans, the design and conduct of our clinical trials, the timing and results of interactions with regulatory agencies, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements.
Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Daniel Tassé, our Chief Executive Officer, as well as Pharis Mohideen, our Chief Medical Officer, and Kevin Trapp, our Chief Commercial Officer. I will now pass the call over to Daniel. Daniel.
Thank you, Jonathan, and thank you all for joining us today. 2026 is and will continue to be a pivotal year for DBV. We are working aggressively to transform the company into a commercial organization in anticipation of the potential approval of the VIASKIN Peanut Patch for children aged four through seven by the FDA. It's certainly a tremendous amount of work to move from the clinical to commercial stage. Today, we'd like to walk you through a summary what we've accomplished toward that goal in the first half of the year. Pharis and Kevin have joined me today to help describe how we have advanced our lead program toward BLA submission, continued constructive engagement with FDA, expanded the VIASKIN Peanut clinical program, and strengthened the foundation required to become a commercial stage company. I'll start with the status of the BLA.
As we shared two weeks ago, we continue to optimize our BLA submission for the VIASKIN Peanut Patch in children aged four through seven through our engagement with the FDA, which has been constructive and collaborative. These discussions have been particularly valuable for a novel, first of its kind product like the VIASKIN Peanut Patch. Let me reiterate, the FDA has not requested additional data. The work underway is focused on incorporating FDA feedback related to the organization, the mapping, and formatting of existing CMC and biostatistical data sets. We believe this is the right work to do now, since our objective is a timely and efficient review of the BLA for VP in four to seven, and we plan to submit an optimized BLA in the third quarter of 2026 to support an efficient FDA review.
In addition to these conversations, our progress in the first half 2026 include important developments in our clinical program. Let me invite Pharis Mohideen, our Chief Medical Officer, to tell you a little bit more about that.
Thank you, Daniel. While much of our team is laser-focused on BLA preparation and submission, we are also working hard to continue to build our scientific platform. Today, I will share an update on four main topics: the COMFORT Toddlers study, the test, THRIVE, and whether or not the prevalence of peanut allergy has changed over the last 10 years. First, let me start with COMFORT Toddlers. I am pleased to say that in the second quarter, we closed recruitment for COMFORT Toddlers, a supplemental safety study evaluating the VIASKIN Peanut Patch in toddlers aged one to three years. This is an important milestone as we look to progress this program. About VITESSE, we presented new data from our phase III study in four to seven-year-olds at the American Academy of Allergy, Asthma & Immunology annual meeting earlier this year.
This data included additional efficacy assessments demonstrating consistency of the treatment effects regardless of baseline eliciting dose and across multiple statistical subgroups. Last month, at the European Academy of Allergy and Clinical Immunology Congress, we presented VITESSE data showing that subjects with asthma, eczema, and or other food allergies, common comorbid conditions for our study population, had no difference in the VIASKIN treatment effect. This is an important dimension of the treatment of food allergies and peanut allergies since they are often accompanied by other atopic conditions. The population of children we recruited in VITESSE is very typical of the overall peanut allergy population seen in allergists' offices.
This data reinforces our confidence in the potential role that the VIASKIN Peanut Patch may play, both for allergists who are navigating the everyday complexities of the food allergy population and for families who are looking for a practical treatment that fits into their everyday lives. Also at EAACI, the design elements for THRIVE were presented by Dr. Kirsten Perrett, who is the co-lead investigator, along with Professor Gideon Lack. THRIVE is assessing the efficacy and safety of the VIASKIN Peanut Patch in achieving ad lib consumption of dietary peanut in infants with peanut allergy aged six through 12 months following three to four years of treatment with the VIASKIN Peanut Patch. We are pleased to have shared the first subject was enrolled in this first-of-its-kind study last month at Dr. Doug Mack's site in Canada.
We believe this study is nicely aligned with earlier introduction of allergens into the diet. Consequently, more patients being identified with a food allergy at an earlier age. Given the positive results of the phase II EPITOPE study in one to three-year-olds, which was published in the New England Journal of Medicine in 2023, we believe that the THRIVE study has the potential to be a landmark study. We pay very close attention to the ever-evolving food allergy treatment landscape. A question that we frequently get is whether the prevalence of peanut allergy has changed. I'd like to take a minute to discuss an important recent publication that informs discussions of the prevalence of IgE-mediated food allergy across children and adults.
Dr. Alessandro Fiocchi, a leading allergist, and colleagues, conducted a standardized survey-based study of peanut allergy prevalence in children using a methodological approach deemed by the FDA as sufficient to produce evidence of high to medium strength. In the U.S., the study reported a 2% prevalence of peanut allergy in children. That estimate is broadly consistent with prior U.S. literature, including the approximate 2.2% prevalence rate previously reported by Dr. Ruchi Gupta and colleagues in 2018. Importantly, the Gupta data were collected in 2015 and 2016, while the Fiocchi data were collected in 2022 and 2023. These two independent data sets, collected approximately seven years apart, both point to a U.S. pediatric peanut allergy prevalence of approximately 2%. The confidence intervals further support that conclusion. Gupta reported a 95% confidence interval of 2%-2.5%, which overlap with the estimates across each pediatric age group in the Fiocchi paper.
I'll hand over to Kevin Trapp to put this new prevalence data into a commercial context. Kevin?
Thank you, Pharis. For us, these findings are highly relevant because they reinforce that the opportunity in peanut allergy in the U.S. has not changed. This is an important point. The Fiocchi data reinforces that peanut allergy remains a persistent population-level issue. Despite early introduction, the peanut allergy patient population remains largely consistent. Peanut allergy also remains one of the most common food allergies in children, and it still creates a daily burden for patients, families, and healthcare systems. That is why our work matters and why, as we move toward BLA submission, we're planning now for what it takes to bring VIASKIN Peanut Patch to the market at scale if approved. For commercial, that means focusing on building the infrastructure a successful U.S. launch requires. We are investing across market access, patient services, brand readiness, field force planning, and launch operations.
We have built the launch model around cross-functional execution. Commercial is working closely with medical affairs, our regulatory team, pharmacovigilance, quality, supply, and manufacturing so that the launch planning is connected to the evidence, our safety systems, product supply, and the regulatory timeline. Our goal in the end, to ensure a prescriber and patient experience that supports their needs and fits into their daily routines. It looks simple on the front end but is so complex on the back end. We're also spending real time with the food allergy community, including caregivers, advocates, physicians, and payers to understand where the greatest barriers exist and how DBV can support adoption of the peanut patch. In short, we're doing the work now to drive both a successful launch and the long-term growth of VIASKIN Peanut Patch.
As part of that longer-term planning, we're taking a close look at company operations that would be required to support potential peak demand for the VIASKIN Peanut Patch if approved. We're reviewing what the future would look like for our manufacturing capacity, supply chain readiness, and related capital requirements. We believe the opportunity is significant and that the patch has the potential to transform treatment in a large market with significant unmet need. Our planning must reflect that potential. Daniel, I'll pass it back to you.
Thank you, Kevin. I would like to emphasize Kevin's last point. The planning that we're doing and the foundation we're building reflect our belief in the potential of the VIASKIN Peanut Patch. At the same time, we always approach these investment decisions thoughtfully in alignment with regulatory progress, commercial readiness, and disciplined capital allocation. In closing, the first half of 2026 reinforced our conviction in DBV's future. We are advancing our lead program in four to seven-year-olds towards BLA submission. We have closed recruitment for COMFORT Toddlers supplemental safety study in one to three-year-olds. We are expanding our VIASKIN Peanut clinical program with the very important THRIVE study. We are funded into the third quarter of 2027 to support operations and commercial preparedness, including investments across our core functions required to potentially launch and support the long-term success of the VIASKIN Peanut Patch.
We're doing all of this with a clear purpose, to help children and families living with the daily burden of peanut allergy. I will now pass it over to the operator for questions.
If you would like to ask a question, please press star one on your telephone keypad now. You will be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star one on your phone now. Our first question comes from Yatin Suneja at Guggenheim.
Hey, guys. Thank you for taking my question, thank you for all the details. Very helpful. Just two quick questions from me.
Yeah.
First is with regard to the filing and the acceptance and the timelines around it. What are your working assumptions? How should we think about the acceptance timelines? Will this be a standard review or a priority review? Then with regard to the CMC readiness and commercial supply, are there any implications from the FDA feedback, any changes in manufacturing dossier or anything you sort of have to do from a launch perspective?
Thanks for those questions, Yatin. Let me start with the first one. The regulatory timelines are we will be asking for priority review given the fact that VIASKIN Peanut, the platform, has a breakthrough designation, thus making us eligible for priority review. As you know, that request is made formally when you file the BLA. We're working closely with the agency on the content of that BLA. That was the purpose of the update a few weeks ago here. After we file, it's up to 60 days for the agency to accept the file for review and share whether or not the sponsor is given priority review. Right now, we're assuming 60 days. Could it be shorter? There's a possibility given how closely we're working with the agency. But the formal timelines are 60 days.
We'll ask for priority review, which would be a six-month review at that point in time. I hope that answers the first half of your question. On CMC, the discussions with the agency on CMC are essentially now completed. We've had all their comments. We're in the process of making the adjustments that they want here. There's nothing that the agency has asked us to do that represents a change in any way, shape, or form to the way we manufacture the product and the way we will describe that in the module three, the CMC section of the BLA.
Got it. One more question, if I may.
Please.
What is now the gating factor or what are some of the things that you need to get either an alignment or you have to complete it on your end? Could you just tell us before you can submit the BLA? Thank you.
There are discussions ongoing, Yatin, as you know, on CMC and also on formatting tabulation of the biostats table. That discussion is also going on in parallel. Completing the discussions with the FDA on CMC and the same completion on biostats are the two gating items right now progressing in parallel.
Thank you very much.
Thank you.
Our next question comes from Sushila Hernandez of VLK.
Yes. Thank you for taking my questions. I also have two. Do I understand correctly that you have engaged with the FDA since the last conference call that you organized? If so, have they provided with additional suggestions on the structuring, mapping of the BLA package or on any other fronts?
Yep. Okay. Those are your two questions, Sushila? Sorry about that. Yes. The short answer is yes, the dialogue with the agency is ongoing when dialogue is both talking as well as exchanging emails. Yes, there's been further discussion of what they want, all of which are things that we're accommodating within, again, nothing that is being discussed right now requires incremental data, or we see as being fundamentally problematic in any way. I trust that answers the two halves of your question.
Yes. Thank you. Then just one more.
Please.
With the recruitment completed of the safety study in toddlers, could you just remind us for how long you will follow these toddlers before the study is completed?
Pharis, you want to take that one? It's your baby.
Yeah.
So with the-
Yeah.
Yeah, with the recruitment completed. Oh, sorry. Yeah, go ahead.
No, it's a six-month safety study. Again, there's no efficacy component to it. We did the food challenge up front to have inclusion/exclusion, it's a six-month treatment period.
Okay. That's clear. Thank you.
Our next question comes from Kristen Kluska of Cantor Fitzgerald.
Thanks so much for the updates. Couple questions from me. First, I think most of us on the line probably have never submitted an application before, can you help us just to try to imagine what it's like to reformat things? Why isn't it as simple as just copy and pasting in other areas? Sorry for the basic question, I think it will help since we don't have this experience.
I appreciate that question, Kristen, because it really is critical. Yeah, there's nothing you do in an office that looks like filing a BLA. This is not a ZIP file you attach to an email. This is not a link to some data site when it comes to doing due diligence. It's a massive document that includes literally hundreds of thousands of pages and tests and validations and protocols, all organized in a way that's obviously delineated under the regulations of the CFRs. All of this includes a lot of hyperlinking so that the FDA can easily, or as easily as possible, navigate from one element to the other one.
All of that rigor and structure needs to be done in a way that is formatted to FDA standards, one, for their ease of review, and two, to make sure that, given the size of that file, there's no issues through the FDA IT firewalls. To add to that, the sense of the massiveness of the undertaking, since there's a lot of linkage of something that's in one part of the BLA to another one, a big part of what sponsors do is to verify that all of those linkages work, and that as you change something, you don't change something in a domino document later on. It sounds like a lot of small things, and that's exactly what it is. It's a lot of small things. I don't know if that answers your question here, but it's a massive undertaking. It's all about details.
Yeah. Thank you so much for that additional color.
Yeah.
On COMFORT Toddlers,
Yes.
Are you still planning to file that later this year, or how should we be thinking about that based on the time to collect the safety data?
Yeah, we are still planning to file by the end of the year. Remember, COMFORT is a supplemental safety study. The pivotal-
Yes.
trial is EPITOPE. Let's not forget that that's already completed here. That shows efficacy. We talked about the amount of commonality and overlap in content of the BLA one to three, four to seven. That's obviously part of things we're learning as we work closely with FDA in four to seven. We maintain our objective of filing by the end of the year, as we work through that logistic. Obviously, that will be in dialogue with the FDA, obviously.
Okay. Thank you so much.
I hope that answered your question.
Appreciate it.
Yeah.
It did. Thank you.
Thank you.
Our next question comes from Jon Wolleben of Citizens Capital.
Hey, thanks for taking the question. A couple on commercial from me. Do you guys have any sense of the average price of Xolair in one-to-seven-year-olds and what pricing bin you guys have been testing with payers?
Kevin, you take that one?
Yeah, Jon, it's Kevin. Yeah, sure. Yeah. As you know, Xolair is IgE and weight-based, so it'll vary across that age range. We've seen prices from around EUR 10,000 into the EUR 30,000s, right, depending on that. We've tested a range of prices. We're not going to finalize anything yet. We've got payer discussions that'll be upcoming here in the next month, advisory boards. The research is being done, and as we get tighter on this, we get closer to launch, we can give you some more ranges.
Okay. When we think about commercial, do you have a sense in your research what proportion of one-to-seven-year-olds with peanut allergy would seek some form of therapy? Digging into that, who would be a likely candidate for VIASKIN Peanut versus who would not be? Any guidance on that?
Yeah. We're working through the segment. Yeah, sure. Yeah. Look, we've done a lot of both parent research and allergist research. I would say that we always see very significant demand as we talk to parents. We know it's not one market. As we continue to look through segmentation and who will activate first, we think there's a number of things in our framework from those that have just been diagnosed or just had a reaction, those that have already sought out immunotherapy but perhaps didn't continue with it for either the burden of frequency of visits or the tolerability. Then there's a group that maybe get farther out in their avoidance at epi, and they may need more education, and they'll be later down the path. We've got our framework, Jon. We're doing a lot of work on kind of segmentation and prioritization.
Again, I think we'll have more to say to that in the second half of the year if we're talking about a commercial day at some point. Is that helpful?
Okay. It'll be more helpful around the commercial day. I appreciate you guys taking the question.
Candor is wonderful. Thanks, Jon.
As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from Sam Slutsky of LifeSci Capital.
Hey, good evening. Appreciate the question. Just in terms of the THRIVE study, could you remind us what the ultimate goal of that is in terms of are you expecting to eventually get a label change with it, whether it's age groups or just the language around treatment in general? Just what's the end goal of that study, hopefully?
Pharis? I can add to it.
Yeah. This is a phase II study. It's really almost more of a proof of concept study, Sam. The objective, and this is sort of trampolining off of the one-to-three-year-old success that we saw in EPITOPE at that age group. We're going a little bit younger. As you know, younger patients tend to have a more responsive immune system. The ultimate goal is to see if these patients can get to the point where they can consume peanut ad lib. We have a very broad definition because one size doesn't fit all in this patient population. At this point, we're running the study. It's not really intended to be a registration study. It's a single-arm study. We've not talked to agencies about what this data set could do. We just started recruitment, as I mentioned. It's in its early stages.
For us, conceptually, it's a natural study to do given the data that we presented with desensitization and sustained unresponsiveness. With the introduction of food allergens earlier, this population absolutely does exist, right? It's early stages, Sam. Again, right now we're going to run the study and see where we end up. If we choose to dialogue with the agencies in the future, we'll have those conversations, but for now, it's open sites recruit and see what the study shows.
I'll add one thing, Sam, if I may. What's not changing here is the duration of treatment, right? We expect kids will be on therapy for three, four, five years. We're trying to do the same thing here in 6-12-month-olds. We could have decided to do this study as part of a phase IV study post-approval. I think the question is too important and too pressing to wait that long. Moreover, we're running this study with obviously some degree of confidence given what we know about our product that is going to show some benefits here. That's why we're calling it a phase II study. It's a question that deserves to be answered, and it does not change the treatment paradigm of using VIASKIN Peanut in toddlers with peanut allergic.
Okay, thanks.
Is that helpful, Sam? Yeah.
Yep.
Thank you.
This concludes our question and answer session. I would like to turn the conference back over to Daniel Tassé for any closing remarks.
Well, next. Oh, there we go. Okay. Well, thank you. That concludes our call for this afternoon. Again, we are very pleased with our progress towards commercialization, remain committed, as we're answering your questions, at transforming the lives of children and families living the daily burden of food allergy. It is a burden. We think we have a technology that can make a big difference there. We're proud of the work that we're doing and the science that we're pursuing to try to change the life of families. Thank you. Good evening, and we'll talk to you soon.
This concludes today's conference call. Thank you for attending.
Investor releaseQuarter not tagged2026-07-14DBV Technologies to Report Second Quarter 2026 Financial Results and Business Update on July 16, 2026
GlobeNewswire
DBV Technologies to Report Second Quarter 2026 Financial Results and Business Update on July 16, 2026
Châtillon, France, July 14, 2026 DBV Technologies to Report Second Quarter 2026 Financial Results and Business Update on July 16, 2026 Company to host investor conference call and webcast at 5:00 p.m. ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Thursday, July 16th, at 5:00 p.m. ET to review its second quarter 2026 financial results and provide a business update. Interested participants may access this call via the teleconferencing numbers below and by asking to join the DBV Technologies Second Quarter 2026 Results call: United States: +1-877-344-8082 International: +1-213-992-4618 A live webcast of the call will be available on the Events section of the Company's website here. About DBV TechnologiesDBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® Patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN® Peanut Patch in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital M...
Investor releaseQuarter not tagged2026-06-03DBV Technologies Announces the Results of its 2026 Combined General Meeting
GlobeNewswire
DBV Technologies Announces the Results of its 2026 Combined General Meeting
Châtillon, France, June 3, 2026 DBV Technologies Announces the Results of its 2026 Combined General Meeting Shareholders approved all proposed resolutions DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late stage biopharmaceutical company (the “Company”), held its Combined General Meeting (the “General Meeting”). The General Meeting was chaired by Michel de Rosen, Chairman of the Board of Directors (the “Board”). The Company’s shareholders approved all resolutions submitted by the Board. The resolutions and voting results are posted on the Company’s website: 2026 Annual General Meeting | DBV Technologies About DBV TechnologiesDBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN Peanut Patch in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. VIASKIN is a registered trademark of DBV Technologies. I...
Investor releaseQuarter not tagged2026-05-01DBV Technologies Reports First Quarter 2026 Financial Results
GlobeNewswire
DBV Technologies Reports First Quarter 2026 Financial Results
Châtillon, France, April 30, 2026 DBV Technologies Reports First Quarter 2026 Financial Results Reported cash and cash equivalents of $229 million as of March 31, 2026 —providing funding into the second quarter of 2027 following the full exercise of the ABSA Warrants and BS Warrants issued in its March 2025 private placement (“PIPE”) financing Continued disciplined execution focused on BLA filing in the first half of this year and commercial preparedness for the U.S. launch of the VIASKIN® Peanut Patch for children aged 4 to 7 years, if approved DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financial results for the first quarter of 2026. The quarterly and three months unaudited condensed financial statements were approved by the Board of Directors on April 30, 2026. “The entire DBV team has been operating with exceptional focus and rigor as we progress towards significant milestones in the coming months, including the upcoming Biologics License Application (BLA) submissions for both our Children ages 4-7 and Toddler ages 1-3 programs in first half and second half of this year, respectively.” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “We also plan to initiate a first of its kind study in infants ages 6 through 12 months. This Phase 2 study, previously announced at last year's American College of Asthma, Allergy, and Immunology, and now called THRIVE, will assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in peanut-allergic infants 6 through 12 months of age following a minimum of 3 years of treatment. Across all development programs, we are operating with extreme precision and purpose with the goal of providing practical, non-invasive treatment options to peanut allergy families no matter where they are on their treatment journey.” Financial Highlights for the First Quarter Ended March 31, 2026 The Company’s interim unaudited condensed consolidated financial statements for the three months ended March 31, 2026, and the comparative period of March 31, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). In the first quarter of 2026, the Company started to execute its plan for growth, building on the key events...
Investor releaseQuarter not tagged2026-03-27DBV Technologies Reports Full Year 2025 Financial Results and Business Update
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DBV Technologies Reports Full Year 2025 Financial Results and Business Update
Châtillon, France, March 26, 2026 DBV Technologies Reports Full Year 2025 Financial Results and Business Update Continued advancing the VIASKIN® Peanut Patch clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old) Bolstered executive leadership team in preparation for BLA submission and potential approval Reported cash and cash equivalents of $194 million as of December 31, 2025, plus additional gross proceeds of $94 million received on January 16, 2026 —providing funding into the second quarter of 2027 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financial results for the full year 2025. The consolidated financial statements are prepared under U.S. Generally Acceptable Accounting Principles (“U.S. GAAP”) and International Financial Reporting Standards (“IFRS”) for the purpose of Form 10-K and French “Document d’Enregistrement Universel” containing the Annual Financial Report – were approved by the Board of Directors on March 26, 2026. “We entered 2025 with a clear set of priorities – strengthening our financial position, advancing our clinical development program (including completing VITESSE and initiating COMFORT Toddlers), and preparing for the BLA submission and commercialization of the VIASKIN® Peanut Patch in the United States, if approved,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “I am pleased with our progress to date in enhancing DBV’s capabilities and building a company ready for launch. Our focus on bringing the VIASKIN® Peanut Patch to peanut-allergic children ages 1-7 years remains unwavering.” 2025 Operational Highlights Clinical Execution Continued to advance clinical program for the VIASKIN® Peanut Patch across both toddlers and children Reported positive topline results from the Phase 3 VITESSE trial in peanut-allergic children aged 4 to 7 years Initiated supplemental safety study, COMFORT Toddlers, for peanut-allergic toddlers aged 1 to 3 years Announced planned clinical study to assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in peanut-allergic infants 6 through 12 months of age following a minimum of 3 years of treatment Scientific Engagement Maintained active engagement with allerg...
Investor releaseQuarter not tagged2025-10-29DBV Technologies Reports Third Quarter 2025 Financial Results
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DBV Technologies Reports Third Quarter 2025 Financial Results
Châtillon, France, October 28, 2025 DBV Technologies Reports Third Quarter 2025 Financial Results DBV closes Q3 2025 with a cash and cash equivalents balance of $69.8 million, taking cash runway into the third quarter of 2026 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company (the "Company"), reported financial results for the third quarter of 2025. The quarterly and nine months unaudited financial statements were approved by the Board of Directors on October 28, 2025. Financial Highlights for the third quarter ended September 30, 2025 The Company’s unaudited interim condensed consolidated financial statements for the nine months ended September 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Operating Income The increase in Research tax credit during the three and the nine months ended September 30, 2025, is primarily due to the fact that more eligible activities have been carried out in the period, including the related costs of the FAREVA platform. Operating Expenses Operating expenses amounted to $107.0 million for the nine months ended September 30, 2025, compared with $96.4 million for the nine months ended September 30, 2024, an increase by $10.6 million driven mostly by the launch of the COMFORT Toddlers supplemental safety study. Net Loss and Net Loss Per Share The Company recorded a net loss for the nine months ended September 30, 2025, of $102.1 million, compared to a net loss of $90.9 million for the nine months ended September 30, 2024. On a per share basis, net loss (based on the weighted average number of 124,723,638 shares outstanding over the period) was (0.82) USD/share for the nine months ended September 30, 2025. Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $69.8 million as of September 30, 2025, compared to $32.5 million as of December 31, 2024, a net increase of $37.4 million. On March 27, 2025, the company announced a private placement financing ("2025 PIPE") of up to $306.9 million (€284.5 million), to...
Investor releaseQuarter not tagged2025-07-30DBV Technologies Reports Second Quarter and Half-Year 2025 Financial Results
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DBV Technologies Reports Second Quarter and Half-Year 2025 Financial Results
Châtillon, France, July 29, 2025 DBV Technologies Reports Second Quarter and Half-Year 2025 Financial Results DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial results for the Second Quarter of 2025. The quarterly and half-year financial statements were approved by the Board of Directors on July 29, 2025. Financial Highlights for the Second Quarter Ended June 30, 2025 The Company’s interim condensed consolidated financial statements for the quarter and six months ended June 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and Europe (IFRS). Operating Income Operating income amounted to $2.2 million for the six months ended June 30, 2025, compared with $2.6 million for the same period in 2024, primarily due to a lower French Research Tax Credit entitlement as a greater proportion of studies activities were carried out in North America and therefore not eligible for the tax credit. Operating Expenses Operating expenses amounted to $69.9 million for the six months ended June 30, 2025, compared with $65.0 million for the six months ended June 30, 2024, an increase by $4.9 million driven mostly by the launch of the COMFORT Toddlers supplemental safety study. Net Loss and Net Loss Per Share The Company recorded a net loss for the six months ended June 30, 2025, of $69.0 million, compared to a net loss of $60.5 million for the six months ended June 30, 2024. On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.58) for the six months ended June 30, 2025 compared with $(0.63) for the six months ended June 30, 2024. Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $103.2 million as of June 30, 2025, compared to $32.5 million as of December 31, 2024, a net increase of $70.7 million. . On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut patch through Biologics License Application ("BLA")...
Investor releaseQuarter not tagged2025-06-12DBV Technologies Announces the Voting Results of its 2025 Combined General Meeting
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DBV Technologies Announces the Voting Results of its 2025 Combined General Meeting
Châtillon, France, June 11, 2025 DBV Technologies Announces the Voting Results of its 2025 Combined General Meeting Shareholders approved all proposed resolutions DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), held its Combined General Meeting (the “General Meeting”). The General Meeting was chaired by Michel de Rosen, Chairman of the Company. The Company’s shareholders approved all resolutions submitted by the Board of Directors. The resolutions and the voting results are posted on the Investors/Annual General Meetings section of the Company’s website: https://dbv-technologies.com/events/2025-annual-general-meeting/. About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary technology platform, Viaskin™, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, 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 five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn....
Investor releaseQuarter not tagged2025-05-01DBV Technologies Reports First Quarter 2025 Financial Results
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DBV Technologies Reports First Quarter 2025 Financial Results
Châtillon, France, April 30, 2025 DBV Technologies Reports First Quarter 2025 Financial Results DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial results for the First Quarter of 2025. The quarterly and three months financial statements were approved by the Board of Directors on April 30, 2025. Financial Highlights for the First Quarter Ended March 31, 2025 The Company’s interim condensed consolidated financial statements for the three months ended March 31, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $13.0 million as of March 31, 2025, compared to $32.5 million as of December 31, 2024, a net decrease of $19.5 million. This decrease includes $19.7 million of cash used in operating activities, mainly in external clinical trial related expenses, notably progress on subject enrollment in the VITESSE Phase 3 clinical trial, as well as Regulatory and Manufacturing activities to support ongoing clinical trials. On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to Advance Viaskin® Peanut Patch through Biologics License Application submission (BLA) and U.S. Commercial Launch, if approved. The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026. The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. These condensed consolidated financial statements do not include any adjustments to the carrying amounts an...
Investor releaseQuarter not tagged2025-03-24DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results...
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DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results...
Châtillon, France, March 24, 2025 DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for Biologics License Application (BLA) for Viaskin® Peanut Patch in 4 – 7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, and Reports 2024 Unaudited Financial Results1 COMFORT Children supplemental safety study in children 4 – 7-years-old no longer required FDA confirms safety exposure data generated from VITESSE Phase 3 clinical study and VITESSE Open-Label Extension (OLE) are sufficient to support a Biologics License Application (BLA) for Viaskin peanut patch in children 4 – 7-years-old VITESSE topline results on-track for the fourth quarter of 2025 BLA submission for Viaskin peanut patch in children 4 – 7-years-old is now expected in the first half of 2026; DBV anticipates this path may accelerate potential launch, if approved by the FDA, by approximately one year DBV also reports unaudited financial results1 for the full year 2024, including cash and cash equivalents DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT, the “Company”), a clinical-stage biopharmaceutical company, today announced that in a Written Responses Only to the Company’s Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required, which accelerates the timeline for a BLA submission of Viaskin® peanut patch in 4 – 7-year-olds with a peanut allergy. The Company also reported unaudited financial results1 for the full year 2024, including cash and cash equivalents. FDA UpdateBased on the Written Responses Only received, DBV will no longer conduct the COMFORT Children 6-month supplemental safety study. The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE), expediting the BLA submission for the Viaskin peanut patch from the previously anticipated timeline. Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerati...