Apologies for the late start of our conference. Welcome to the DBV Full Year 2023 Financial Results and Business Update Conference Call. All participants will be in listen-only mode. Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Thank you. And again our sincere apologies for the delay in starting today. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31st, 2023. This press release 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 clinical and regulatory development plans, the design of our anticipated clinical trials, the timing and results of interactions with regulatory agencies, our forecast of our cash runway 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 Dr. Daniel Tassé, Chief Executive Officer of DBV; Dr. Pharis Mohideen, DBV's Chief Medical Officer; and Virginie Boucinha, our Chief Financial Officer. Before handing the call over to Daniel for those of you who may be new to DBV, we are developing Viaskin, an investigational proprietary technology platform with broad potential applications as an immunotherapy for the treatment of food allergies and other immunological disorders with Viaskin Peanut as our lead candidate. I will now pass the call over to Daniel.

Katie, thank you and thank you everyone. Again, I need to add my apologies; we were in fixed confirmation that the K had been uploaded. It usually takes a minute. It took much longer today. We will obviously dig into this and make sure it doesn't happen again. So my apologies for having you on hold for 30 minutes. Today, we'll obviously give you an update on our progress when it comes to Viaskin Peanut programs and regulatory pathway and then Virginie will share with us the financial update. But before we do that, I'd like to share with you a few perspectives about Viaskin Peanut and the peanut allergy market, things that we have not discussed in a while. Starting the data, last week DBV attended the American Academy of Allergy Asthma Immunology Annual Scientific Meeting which was held in Washington D.C. The meeting which is known as AAAAI is regarded as the premier event in the allergy immunology community and every year we have a lot of boots on the ground at AAAAI to listen, engage with our key stakeholders, allergists, and patient advocacy groups at the very top of that list. One of the highlights of AAAAI this year was the fact that the product theater attended by allergists, was called Importance of Early Intervention for Peanut Allergy. And I'm very proud to say that it had an unprecedented attendance. In fact, we're told that we broke the record for AAAAI events with 223 allergists showing up. The point here being that intervening early in peanut allergy is important, our technology's important, creating much interest, and obviously that's the most validating feedback there is on the hardware that's been going in, which I'd like to use to just again reinforce our commitment to this space and to the importance and the benefit of generating plenty of data and long-term data. We understand the huge responsibility we have of establishing the long-term safety and clinical benefits of Viaskin Peanut because treating children is an important responsibility. Our open-label extension commitment to patients, while it takes time and effort and financial resources ensures a rich population of subjects on Viaskin Peanut to guide treatments, inform options, and optimize outcomes for patients. We do have extensive follow-up of our subjects. You may recall, we recently reported back in November, our interim year two data from our open-label extension study in toddlers. And obviously, we cannot wait to see what the year three data will look like when we share it later on this year. In 2024, we will continue to work towards streamlining a robust data package in toddlers and children. We have a lot of work cut out for us, but we're enthusiastic about next year. We expect to have approximately 1,400 children, aged one to seven, enrolled globally in our Phase three trials. All our Phase IIb studies have an open-label extension, which, as I mentioned just now, is key to understanding long-term treatments and the benefits of our therapy. It goes without saying we will have the largest cumulative exposure to investigational product ever in pediatric food allergy, it is going to be a massive safety database for our one to seven year olds who have, in fact, close to 1,700 subjects on active treatment. We combine that with the data from our prior Phase two trials. We break this down with approximately 600 toddler patients, 600 toddlers aged one to three and about 1,100 patients aged four to seven, who will have been on immunotherapy for up to three years. And let's not forget all the work we've done in four to 11 before that, where some of those children were treated with Viaskin Peanut for up to five years. In summary, over one million Viaskin patches have been applied to children aged one through 11 in our clinical development program. That's obviously more than one million days of therapy that makes up the safety and efficacy database as described. As I said, it is the most comprehensive research in children with peanut allergy. We have a well-studied product, with demonstrated efficacy and a consistently favorable safety profile. We're proud of that and we keep on building that database. The second point I wish to touch on today is the disease-modifying potential of Viaskin Peanut. I'd like to share with you data that's been discussed in the past but put together I think as an important perspective here. Let's start with our recent and striking observation in toddlers from year two of our ongoing open-label extension study. Data showed that approximately three out of five toddlers could consume almost 3.5 grams of peanut protein without triggering stopping symptoms during the food challenge. That is the equivalent of 12 to 14 peanuts, way beyond what we anticipated during accidental exposure and a massive jump from a median eliciting dose at baseline of 100 milligrams. These data suggest that Viaskin Peanut is potentially rewiring immune systems and we suspect that it is due to a plasticity in immune systems in this age group. We also have two other data sets from prior studies showing that Viaskin Peanut can induce what is known as sustained unresponsiveness to the allergen in older children, who after two to three years of treatment, 8% of participants maintained desensitization of 1000 milligrams or more at two months after stopping treatment. Thirdly, we know from our studies in animal models that the data suggests the Viaskin Peanut induces sustained unresponsiveness of the allergen by modulating the epigenetic signature of specific T-cell compartments. Remember Viaskin Peanut has a unique mode of action that leverages skin properties to induce tolerance, and there's no other product that shows that mode of action. With all this in mind while this has not been the case we'll be pursuing at approvals, we fully intend post-approval and as part of our long-term commitment to exploring Viaskin Peanut as fundamentally disease-modifying after a few years of treatment. With that as background on our commitment to science and to our patients, I'll turn the call over to Pharis, our Chief Medical Officer, for a detailed update on our two best internet programs.

Thank you, Daniel. As a reminder, we intend to submit two separate BLAs for the treatment of peanut allergy. In the one to three year olds, we are using the original square patch. The 12-month efficacy study EPITOPE is completed and the results were published in the New England Journal of Medicine. The pre-BLA meeting held in April of 2023, the FDA did not request any additional efficacy data but did request a supplemental safety study to increase exposure on the active product to close to 600 subjects per ICH guidelines. To be clear, the FDA was not looking for a specific safety signal or a specific safety concern. We call this six-month safety study COMFORT Toddlers. In parallel, we are running the four to seven-year-old indication with the modified circular patch. We started this program last year with a 12-month PEPITES study. Recruitment is ongoing at this time. This indication will also have a six-month supplemental safety study, which we call COMFORT Children. The two studies combined will have 600 subjects on active treatment to meet the ICH guideline. So our attention this year will be focused on completing recruitment for the tests and starting our two supplemental safety studies. As Daniel mentioned, DBV has always been committed to generating the most robust data set possible in our clinical trials. The test is no exception. We recently submitted an amendment to extend the open label phase so that every subject enrolled in the trial has the opportunity to receive Viaskin Peanut for up to three years. Remember, we also have our expanded access program for subjects that have completed treatment in a DBV clinical trial and want to continue to receive Viaskin Peanut. So that test is set up to provide another large robust dataset unmatched by any other peanut allergy study in this age group. Recall that the population in the test is considered to be more sensitive than subjects in our previous studies, with the inclusion eliciting dose set at 100 milligrams. This is aligned with the younger four to seven-year-old age group where we believe Viaskin Peanut can provide great clinical benefit. In the test, we have 86 clinical centers spread across the US, Canada, Australia, and Europe; sites in every country are open and actively recruiting subjects. Like other sponsors, we were set back by the new European clinical trials directive, which significantly delayed our opening of our European sites. However, that's behind us now, and we expect to build momentum and complete screening by Q3 this year. That brings me to the COMFORT Children supplemental safety study in four to seven-year-olds. This will have a six-month core period followed by an open-label extension that will provide an additional six months of treatment for subjects randomized to active product and 12 months of treatment for subjects randomized to placebo. Every subject will have the opportunity to receive Viaskin Peanut for a full year. This will be a 270-subject study randomized three to one active to placebo. The main inclusion criteria will be based on skin prick test and peanut-specific IgE levels. These criteria are sufficient to ensure a similar patient population relative to the tests. Thus, there is no need for a food challenge as part of the inclusion criteria. One of the differences in COMFORT Children relative to the tests, is the use of simplified instructions for use. The safety study IFU states each DBV’s 712-microgram epi-cutaneous system is intended to be worn for a full day, 24 hours. This is a shift away from the previous minimum wear time used in previous studies. This new IFU, more accurately reflects allergen immunotherapy and how we expect our product to be utilized if approved. Based on a past similar safety study we conducted in four to 11-year-olds, we believe COMFORT Children would be an attractive study, with potential subjects and at research centers. Be assured that study start-up activities with our CRO have already begun so that we will be in a good position to initiate the study at an optimal time. Okay. Let's move to the top of the program. The results from the first 12 months of the EPITOPE study were published last year in the New England Journal of Medicine. The Open-Label Extension to EPITOPE is ongoing. Recall that all subjects have the option to receive Viaskin Peanut for up to three years. For subjects originally randomized to active treatment, we have data for two years on treatment and for those randomized to placebo, we have the one-year crossover data from placebo to active. These data were presented as the very first ever late-breaker at the American College of Allergy, Asthma and Immunology annual meeting last November. In the interim data, from the Open-Label Extension to EPITOPE, we observed continued improvement and treatment response following the 2nd year of treatments, which is consistent with our previous Open-Label Extension data in four to 11-year-olds. Using the Responder criteria in EPITOPE, the response rate increased from 67% to almost 84%, and four out of five subjects, 81%, consumed an eliciting dose of greater than or equal to 1000 milligrams. To put this into perspective, the median eliciting dose at baseline was 100 milligrams. That's a tenfold increase. Finally, 56% of participants consumed the entire food challenge of nearly 3.5 grams or about 14 peanut kernels without meeting the food challenge stopping criteria. We believe these are really impressive results that continue to build upon our extensive and robust Viaskin Peanut clinical dataset. During the 2nd year of treatment, the safety results in toddlers were entirely consistent with trials in older children, which demonstrated a well-tolerated, predictable safety profile. Local application site reactions were the most commonly reported adverse events, though notably the frequency of such reactions decreased in the 2nd year of treatment with Viaskin Peanut. No subjects had treatment-related serious treatment-emergent adverse events during the 2nd year of treatment with Viaskin Peanut and no treatment-related permanent study discontinuations occurred. Furthermore, there were no treatment-related anaphylactic events during the 2nd year of treatment with Viaskin Peanut. Remember, our studies used a very broad definition of anaphylaxis, principally designed to set a very low bar in reporting anaphylactic events. Overall, we were extremely pleased with the results of the 2nd year of treatment from an efficacy point of view as well as from a safety point. We didn't present the placebo crossover data in the slides today, but it was discussed at the college meeting in November, and the placebo crossover efficacy and safety appeared to be virtually identical to the first 12-month data set in EPITOPE that was published in the New England Journal. This confirms what was observed previously and also provides reassurance that slightly older subjects of three-year-olds in EPITOPE who crossed over as four-year-olds in the Open-Label extension experienced a robust treatment effect. This bodes well for the VITESSE study. Let me wrap up with the toddler, COMFORT Toddler study. This is a six-month study that will include 400 subjects randomized three to one active to placebo. Like the COMFORT Children study, subjects will have the opportunity to receive active treatment for up to one year. COMFORT Toddlers will use the same IFU as COMFORT Children. So, there will be consistency between the two studies. This study will use the same square patch as the EPITOPE study. One of the differences between COMFORT Toddlers and COMFORT Children other than the obvious difference in age range and patch is that the toddler study will use a double-blind placebo-controlled food challenge as part of the inclusion criteria. We chose to include a food challenge to ensure that the study population in the safety study would be as closely matched to that of EPITOPE as possible. We believe the food challenge was the best way to ensure that outcome, as unit-specific IgE is more reliable as a biomarker of peanut allergy in older children but is less reliable in toddlers. Our EPITOPE data shows that half of our subjects had peanut-specific IgE levels at or below 14, but still tested positive for peanut allergy by food challenge. That is, they had low IgG levels, but were still allergic, whereas the older subjects in the middle and far-right figures on the slide had many fewer subjects with low IgE that were peanut-allergic. We appreciate that this adds a bit of complexity to the study and may have a small impact on recruitment. But we believe this will allow us to best replicate the EPITOPE study population for a BLA submission in the future. As we have stated previously, we will initiate COMFORT Toddlers after we receive FDA feedback on the protocol, which was submitted in November last year. The DBV clinical team has been gearing up with our CRO for study initiation. We believe we are in a position to initiate the study shortly, pending FDA feedback on the protocol.

Thank you, Pharis. Before turning the call over to Virginie to review the financials, let me cover a corporate update. During the fourth quarter, we further strengthened our leadership team in advance of our two BLA submissions and anticipated commercialization, so that we are best positioned for long-term success. On top of our new CFO, Virginie, who joined us in November, we appointed Dr. Kevin Malobisky, PhD, as our new Chief Operations Officer. Kevin has an extensive track record of more than 35 years in biopharmaceuticals, strategic and operational leadership roles, including roles that span both research, as well as drug development and drug approval. Kevin will be instrumental to a successful BLA submission, and I couldn't be more thrilled that he has joined our leadership team. I would like to take the opportunity to formally welcome Kevin to our team, and he's already making a very positive impact. So, really delighted to have both Virginie and Kevin joining us. Without further ado, we'll invite Virginie to cover briefly our financial highlights.

Thank you very much, Daniel. And I will now provide a brief overview of our financials for the year 2023, which I invite you to further review in our press release and filings. There are three highlights I would like to point out for year 2023. Number one, we closed the year with $141 million in cash. Number two, we dedicated over 90% of the cash we used in operations to progressing Viaskin Peanut's clinical development and preparing for BLA filing. Number three, our 2023 P&L includes the favorable impact of the termination of our collaboration with Nestlé. As you may be aware, in the fourth quarter of last year 2023, we terminated a collaboration agreement with Nestlé, which was meant to develop and commercialize a diagnostic market for cow's milk allergy. This contract was draining resources and attention away from our priority Viaskin Peanut, with neither tangible nor medium-term income. Terminating the contract was a financially sound decision with a materially positive impact on 23 financials expenses and net loss. One more word on our financials and resources allocation. If you consider our financial statements without the impact of the Nestlé collaboration agreement, our operating expenses increased by 25% in 2023 to support Viaskin Peanut clinical studies, CMC preparation regulatory activities, and getting ready for the manufacturing site in view of all of this for the approval and launch.

Thanks, Virginie. Now before communicating DBV's upcoming milestones, I would be remiss if I did not take a moment here to appreciate how much the food allergy landscape has changed in the past few years and we believe Viaskin Peanut will serve that community. There's nothing. We see more clearly from the food allergy community that this therapeutic area desperately needs treatment alternatives. The recent FDA approval of omalizumab for the treatment of food allergy in adults is a welcome addition. We see treatment for food allergies requiring a range of options just like other immunological conditions such as asthma, atopic dermatitis, or inhaled allergies. I'm asking you here to imagine the position of a parent with a young child diagnosed with peanut allergy in a pediatrician's or allergist's office. Until very recently, they had no options available to them; the only recommendation was avoidance and being prepared with an epinephrine auto-injector. Today is a different story. Over time we keep on getting better. Children are now channeled to the allergist's office, where they and their families can have real conversations about their conditions and the circumstances surrounding the life of that child. That was another topic that we picked up in talking with KOLs and experts at conferences. Having a range of treatment options available only fuels that conversation, and for the 670,000 children in the US aged one through seven currently living with the daily burden of a peanut allergy, every patient story and situation is unique, requiring a bespoke solution, and that's what's needed here. Simply put, one size will not fit all. In an ever-evolving market and we want to be very much part of that evolution, Viaskin Peanut will always be an important product; in fact, it will be considered a foundational product as was evident after speaking with hundreds of allergists at the recent conference. Before I open up the call for questions, I would like to take a moment to share our anticipated milestones for 2024 and this is a critical year for DBV. We anticipate initiating the first subject of our COMFORT-II trial, the six-month supplemental safety trial in support of the BLA. We also anticipate completing enrollment of our ongoing Vitesse Phase 3 efficacy trial in children aged four to seven years. Once the VITESSE enrollment is close to completion, we'll initiate recruitment for our six-month COMFORT Children trial in support of that BLA. Recruitment as far as touched on will be carefully timed so as not to compete for the same study subjects across two different clinical trials. During the second quarter, we also plan to host an Investor Day and we will share those details as soon as possible. We hope many of you will be able to join us. We also plan to announce the three-year results from our ongoing Phase 3 open-label extension of the October trial earlier this year. Finally, DBV continues to operate very actively, anticipating the publication of additional manuscripts, which include publications of results from the year-two open-label extension of EPITOPE, which Pharis showed a few minutes ago, alongside additional peer-reviewed scientific journal submissions and abstracts of new results for presentation at upcoming conferences. We'll keep publishing data on our technology and its benefits. With that, we'll now ask Pharis and Virginie to join me for the Q&A. Operator, if you could open up the lines for questions, that'd be great.

We will now begin the question-and-answer session. Please follow Operator instructions. Jon Wolleben with Citizens JMP. Please go ahead.

Hey, good afternoon and thanks for taking the questions. First, I was hoping you can give a little bit more color on this EU directive. And then also can you comment on how many of the 600 expected patients in VITESSE you’ve already enrolled to date?

I'll have Pharis answer the question on the directive.

Yeah, Jon, it’s Pharis. So this EU directive is a little bit different from how things were done in the past. You have to submit your dossier, your protocol, and the countries that you've selected in Europe are all banded together essentially as one country. So in the past you could go one-off to Germany, Italy, Spain, whichever countries you want to; in this case they're all bundled into one. If any country has any objection, it has to be resolved all the way, and that process can continue almost indefinitely. The big difference here is if one country protests and has an issue, all of the countries are stuck, they can't participate and you can't pull out and go separately to all the different countries. So it is a bit different, and I think the challenge here was we were one of the first Phase 2 protocols that went through. So the system wasn't quite worked out, and I think there was just a glitch. As these new things come through, they aren't always well-oiled. So that's the nature of the difference in the directive now versus how it was in the past.

Got it. And can you comment on how many of the expected 600 patients have been enrolled so far?

We do not provide specific guidance for competitive reasons. The study is progressing well according to our forecast. Assuming sales were on track, we have been operating as expected. I can share that we believe 60 to 90 days will be adequate to navigate the new directive process. Previously, it took us exactly nine months to complete this process, which is why we have prudently adjusted our timeline for the last patient screening from the second quarter of 2024 to the third quarter of 2024.

Got it. Okay. And any timing guidance on when COMFORT Toddlers will be starting? And then how do you think about the parallel programs? Do you want them to be exactly parallel with BLA submissions in the same time period? Does that make it easier for you or potentially the review division? Or could there be staggering with one coming before the other?

Yeah. I'll have Pharis answer the first question on COMFORT Toddlers, and I'll talk about the benefits of having the two programs being parallel.

Yeah, Jon, as we've always said, we will start our Phase 3 programs when we have FDA feedback, so we're waiting for the FDA feedback. We've done all the preparations we can in terms of the team to be ready to go once we get that feedback. We believe it will be a short turnaround from a financial standpoint. So again, it is the right thing to do for Phase 3 trials to get FDA feedback in alignment before we start running.

And we're in communication with them, and they may reinforce to us that this is a top priority. We very much see that, but we're just waiting for that final sign-off before starting the study out of, again, common-sense prudence.

And then the other question?

Yeah, to come back to the benefits of the two programs in parallel, is that your other question?

Yes, yes please.

Look, both markets are unique. It really comes down to the rate of commercial potential of each. Obviously, the program in toddlers is more straightforward; it is only one study to run. What we have to run with in the four to seven-year-olds involves more complexity. That is why we were very happy when the agency agreed that these would be two separate BLAs, making them equal so that whichever one can file first will be the priority. So, from a commercial standpoint, we will prioritize whichever that is ready first.

Okay. And then just to …

That makes sense?

Yes, yes please.

Last one for me, Daniel. I know you touched on this, but product approval. Can you discuss how allergists you speak to are thinking about Viaskin Peanut is used versus the older used EPITOPE? Do you think there's an overlap between the patients that may like both, or do you think these are going to be separate addressable markets based on the product profile? I will jump back in the queue. Thanks. I'll have Pharis to give you more detail, because the stuff we've talked about adds context. I know there's very little overlap between the two markets, which is why the approvals of both are important here by offering options. The populations are significantly different. So, Pharis will share that perspective.

Sure. We spent quite a bit of time talking to our different sites. And the take-home message we're getting from them is that, the older product has been approved for a long time and has been used off-label with OIT in certain situations. However, there hasn't been huge off-label use for peanut allergy as a standalone indication or even multiple food allergies. The reason for our one to seven-year-olds is that none of the investigators we spoke to would use it as monotherapy for multiple food allergies or single food allergies in the toddler population because the immune system is still evolving and very immature. Plus, it's an injectable. In older patients of maybe six or seven, we've heard there could be extreme cases where patients are ultra-sensitive. An example given to me by a practitioner was of a patient who could go to Chuck E. Cheese and be so allergic to just the residual cheese grease that if they touched it after their eyes, they would go into an anaphylactic reaction. For such extreme cases, that patient might be a candidate for Omalizumab. But these situations don't overlap much with our target demographics. I hope that helps clarify things, Jon.

No, it's consistent with what we're hearing as well.

Yeah.

So good to hear the feedback and color, guys.

Sure. The formal market research also besides data with KOL shows that it could be used in older kids and adolescents or young adults who are multi-allergic at times in their life where you want to ensure their safety. It's not the population that we wish to help with our product.

Our next question comes from Sushila Hernandez with Van Lanschot Kempen. Please go ahead.

Yes. Thank you for taking my question. Could you just walk us through the steps ahead to get to the BLA filing for the Toddlers? And the second question does your cash runway until the end of Phase 4 includes the start of both safety studies? Thank you.

Good question. Yes, our forecasts have always been smart and conservative. This assumes not only the initiation of those two studies but the continuation of the test, a lot of work we do, and also regulatory dossiers, CMC, and building up inventory also. A lot of our expenses this year will be allocated there. As far as next steps for the toddler dossier, we will need FDA sign-off on the protocol and then initiate the trial. As Pharis said, we can turn that around pretty quickly. What we don't know is how quickly this study will enroll. However, we know there's a lot of enthusiasm for that study. Food challenges in toddlers are much easier to conduct than with older children. So we are confident this study will enroll at a good pace. But as there are no analogs here, we are going to leave that as an open question until we have more data to guide expectations and the timing for the BLA filing. Once we have the clinical data, we expect to move quickly on the filing. The CMC work will be done by then, and it's not complex.

Yes. 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.

Covered a lot today and thanks for those questions. To recap, we're continuing to advance VITESSE, our Phase 3 study in peanut allergy children aged four to seven. In parallel, the successful completion of the supplemental COMFORT safety studies is important. As I shared with our colleagues asking questions here, we have two BLAs that are distinct and in parallel and thus, one is not relying on the other. The moment we have sign-off on the pediatric protocol, we will initiate that study as well. We are very confident this work will support BLAs for both age groups. As we've picked up from dialogues with allergists at the AAAAI, we notice that families want treatment options. The more treatment options that are available, the more dynamic the market becomes and we all benefit from that. This concludes the call for today. Again, we hope to maintain conveying the success of our programs into 2023 and 2024. We're laser-focused on execution. Lastly, I want to apologize again profusely for a call that started later than expected. I thank you all and wish you a good evening.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.