DBV Technologies S.A.

Welcome to the DBV Technologies three-year results from the Open Label Extension to Epitope Phase 3 Trial Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions, To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. 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. This afternoon, DBV Technologies issued a press release announcing year three results from our ongoing open-label extension to the epitope phase three trial, DBV's prior phase three efficacy study, which evaluated vascular peanuts in toddlers ages one to three years old, as well as data from epitopes supporting a potential labeling approach for vascular peanuts. 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 plans and expectations with respect to our clinical trials, plans with respect to submission of BLAs to FDA, expectations with respect to any actual regulatory pathways, including an accelerated approval pathway, 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 a 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 AMS 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, Chief Executive Officer of DBV, and Dr. Faris Muheddin, our Chief Medical Officer I will now pass the call over to Daniel. Daniel?

Katie, thank you, and thank you all for joining us on this call this evening. Before diving into the details of today's press release, let's provide a quick recap of the clinical development pathway for via skin peanut in toddlers and in children. Recall that we have two via skin peanut patches, the original square patch for toddlers ages 1 to 3 years old, and the modified larger circular patch for children ages 4 to 7 years old. Each patch is regarded as a separate product candidate by the FDA and hence follows its own regulatory pathway, meaning that we plan to submit two BLAs, one for each age group. You will recall from our last conference call last month that we believe we have clear and straightforward regulatory pathways for the ISKIN-PNUT patch with the FDA. To recap, for our Togglers program using the original square patch, we plan to submit a BLA under the accelerated approval pathway. which we anticipate taking place in the second half of 2026. At that time, we will have completed two phase three studies, EPITOPE, the phase three efficacy and safety study, which has already been completed, the report and the results were published last year, making 2023 in the New England Journal of Medicine, and the Comfort Toddlers Six-Month Supplemental Safety Study, which is on track to be initiated in Q2 of 2025. A post-marketing confirmatory study will be initiated at the time of DIA submission, as agreed to with the agency. Now, similarly, for a children's program using the modified circular patch, The BLA will consist of two core Phase III studies. The ongoing and fully enrolled V-test trial in children with top-line debt expected in Q4 of this year. That data will be coupled with a six-month supplemental safety study, which is called or will be called Comfort Children, is also on track to be initiated in Q2 of this year. Like toddlers, we anticipate a DLA for children program in the second half of 2026. Now, we will focus on our toddlers program for today's update call. Now, I would like to take a moment to remind everyone on the call that ViyaSkin Pnet is a novel technology that has no analogs on the market or in development. And remember also that Viascain Peanut has breakthrough designation. And over the last year, we have worked closely with the FDA to build a mutual understanding of EPIT and the Viascain platform that we hope will benefit all our future Viascain programs, and most importantly, benefit patients. As you know, unlike other immunotherapies approved or in development, ViaSkin platform, ViaSkin PINA as a product targets the upper layer of the skin and relies on specialized antigen-presenting cells within the epidermis. These cells are known as Langeren cells. And Langeren cells pick up and process allergens and migrate to local lymph nodes to progressively induce tolerance and thus a benefit for the child. Not surprisingly, Due to the novelty of the ViaSkin platform, we have had to work together with the agency to pave the way, not just the potential approval of ViaSkin Peanut, but also for our other ViaSkin programs in development beyond food allergy and other immunological disorders. This also bodes well, then, for other novel therapies in development. Because of the novelty of our product, there are some valid questions from caregivers and physicians that we will need to answer in preparation for the launch of iSkin Peanut if approved. For instance, how is iSkin Peanut going to be used if approved? And two key questions. What are we going to tell prescribers? What would the label say to prescribers and caregivers on how to use the product? And what will the label look like? Again, it's a unique product that has no analog. And secondly, and importantly, what is the likely duration of treatment by skin peanut? What are the benefits that accrue with a longer treatment? Hence, trying to further understand the everyday use of a novel product like via skin peanut is essential. And today, I am, we are delighted to announce that we have two additional data sets which we strongly believe will help address these questions. So, yes, we have several positive highlights to share with you today. First, I'm delighted to announce positive results from the ongoing open-label extension of the Epitope Phase III Trial, DBV's prior efficacy study, which evaluated via skin peanut intolerance, age 1 to 3. As you saw in today's press release, these data, which show continued improvement in treatment benefit of via skin peanut after 36 months of total treatment, were accepted as a poster at this year's Eastern Food Allergy Comorbidity Conference, which kicks off tomorrow, January 9th, and runs through Sunday the 12th in Palm Beach, Florida. And they'll be presented by Dr. Matthew Greenhut of Children's Hospital in Colorado. It is well understood in the allergy community that the benefits of the immunotherapy can be achieved with long-term treatment, which is why We are very committed to these open label extensions. They're critical, and they're important for us to best capture and understand the use in real life in the long term of our products. The data help further characterize clinical response and help us form hypotheses on achieving the best long-term outcome for patients. I'm absolutely thrilled to share with you the results of our open-label extension study in toddlers with by-skin peanut, which shows further continued improvement through 36 months of treatment across all efficacy parameters. I'll let Faris share the detailed data, but suffice it to say that they are consistent with the efficacy and safety seen after long treatment periods in our prior studies. More patients respond, and overall, they respond better. We also recall that we have observed statistically significant improvement in efficacy measures after two years of therapy, and that was presented last year, or at least in November of 2023, at the college. There are several highlights of this new data set in toddlers, but what is particularly striking to me is that among subjects on active treatment epitope who continued this open-label extension study, after three years of total treatment of ice cream peanut, Almost 70%, 7 in 10, of subjects completed the oral food challenge at a cumulative equivalent of 12 to 14 peanut kernels without triggering stopping symptoms. Way beyond what could be anticipated during accidental exposure, which is often as little as a fraction of a peanut kernel. In fact, the median dose for patients coming onto our studies is exactly that, a fraction. of API kernel, and something that has the potential to be rather transformative to the life of these families. Another key finding from our open label extension study was a consistent safety and tolerability profile in the tolerance age group, as Faris will elaborate on shortly. But in a nutshell, no new safety findings were observed. and local treatment-related events, such as skin reactions, which are the most commonly reported adverse event with myosin and PNAP, further improved after three years of total treatment with myosin and PNAP. So efficacy improves, tolerability improves. The second part of our call today will focus on daily patch wear time data from Epitope that is supportive of our proposed labeling strategy that we've offered FDA. You may recall. that we proposed the strategy to the FDA in June of last year, and this was a pivotal catalyst in our discussions with the agency to gain accredit approval status of the rice and peanut program in toddlers. As I have articulated previously, providing prescribers and parents with clear, data-driven instructions in the rice and peanut patch label on how to manage The unavoidable, and you'll see the data from Farris, the unavoidable variability in daily patch wear time and its potential impact on treatment effectiveness is of paramount interest to us here at DBV. If a skin peanut is approved, a valid question will, of course, be asked by some parents. Can my child benefit from skin peanut therapy if he or she cannot wear the patch for 24 hours every day? Now, because Vasculpina is a novel therapy, it understandably took some time to come to alignment with the agency regarding how to collect the wear time data from patients to help answer that question, to agree on how to analyze those data, and how to translate those results into meaningful guidance for both allergists and families. And today, we will share with you those data that form the basis of our labeling approach that was proposed to the FDA. This important data will be shared also at the Eastern Food Allergy and Comorbidity Conference as part of a poster presentation by Dr. Edwin Kim. As will become even more evident to you when I hand over to Faris momentarily, we have made significant strides in our Vice and Peanut Toddler Development Program for last year. We are excited, but it's potential to help toddlers with peanut allergies, and I am inviting Faris to provide you even more granularity. Faris?