DBV Technologies S.A. (NASDAQ:DBVT) Q4 2023 Earnings Call Transcript

DBV Technologies S.A. (NASDAQ:DBVT) Q4 2023 Earnings Call Transcript March 7, 2024

DBV Technologies S.A. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: 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. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Katie Matthews: 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. Daniel?

Daniel Tassé: 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 regard as the premier events 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 very top of that list.

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Q&A Session

One of the highlights of AAAAI this year was the fact that the product theater who’s been to AAAAI, the product theaters are a big deal and attract a lot of traffic. The one we hosted was called Importance of Early Intervention for Peanut Allergy. And I’m very proud to say that had an unprecedented attendance. In fact, we’re told that we broke the record for AAAAI events and the best attended product theater ever. There held 125 people, 223 allergists or more showed 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 the data and plenty of long-term data.

We understand and 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. And 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 stream a robust data package in toddlers and children.

We have a lot of work cut 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 understanding long-term treatments and the benefits of our therapy. And it goes without saying, we will have the largest cumulative exposure to investigational product ever in pediatric food allergy 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. And we combine that with the data from our prior Phase two trials. We break this down with approximately 600 toddler patients, 600 toddlers age one to three and about 1,100 patients age four to seven.

We’ll 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. And that’s and that data was shared at quite a high last weekend. To sum it all up and put this in perspective, over one million Viaskin patches have been applied to children age one through 11 in our clinical development program. That’s obviously more than one million days of therapy that makes up the safety database of this product’s, safety and efficacy database as described. And it is as I said the most comprehensive research in children with peanut allergy. We have a well-studied product, with demonstrated efficacy and 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 study 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 what was a median eliciting dose at baseline of 100 milligrams.

These data suggest that Viaskin Peanut is potentially rewiring immune systems and we suspect that is due to a plasticity immune system 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 Amylin 1000 milligrams or more at two months after stopping treatment. And thirdly, we know from our studies in animal models that the data suggests the Viaskin Peanut induces sustained unresponsiveness of the Allergan by modulating the epigenetic signature a specific T-cell compartments. Remember Viaskin Peanut has a unique mode of action that leverages skin’s in properties induce tolerance and there’s no other product.

I would add there that shows that mode of action. With all this in mind while this is not been the case we’ll be pursuing at approvals, we fully intend post-approval. And as part of our long-term commitment to these sooner exploring Viaskin Peanut is 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.

Pharis Mohideen: 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 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 test and starting our two supplemental safety studies. As Daniel mentioned, DBV T 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.