DBV Technologies S.A. (DBV) Earnings Call Transcript & Summary

Welcome to the DBV Technologies Interim Results from the open-label extension to EPITOPE Phase III trial Conference Call. [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.

Thank you. This afternoon, DBV Technologies issued a press release announced the interim results from our ongoing open-label extension to the EPITOPE Phase III trial, DBV's prior Phase III efficacy study, which evaluated Viaskin Peanut in toddlers ages 1 to 3 years old. This press release is available in the Press Releases section of the DPV 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 the therapeutic potential of Viaskin Peanut and EPIT, our clinical and regulatory development plans, the timing and results of interactions with regulatory agencies, our forecast of our 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 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, 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. Pharis Mohideen, our Chief Medical Officer. Also joining the call today is DBV's new Financial Officer, Virginie Boucinha. I will now pass the call over to Daniel. Daniel?

Thank you, Katie, and thank you all for joining us on this call today. This afternoon, we are pleased to announce our 12-month interim results from the ongoing open-label extension the EPITOPE trial, DBV's efficacy study, which evaluated Viaskin Peanut in toddlers ages 1 to 3. This data, which depict efficacy and safety with Viaskin Peanut after 24 months of treatment were accepted as a late-breaking abstract at this year's American College of Allergy, Asthma & Immunology's Annual Scientific Meeting, also known as the College, which kicked off today and runs through Monday, November 13 in Anaheim, California, and this is where we all are right now. We look forward to know a presentation this Saturday at 9:35 Pacific Time presented by Dr. Matthew Greenhawt from Children's Hospital in Colorado. Now I'm thrilled to be sharing the interim results of our open-label extension study in toddlers. As you know, Viaskin Peanut is a novel form of immunotherapy. It is well understood in the allergy community that the benefits of immunotherapy are often best achieved with long-term therapy, which is why these open-label extension trials are so important. They help characterize clinical response and also help us form hypothesis on how to achieve best long-term outcomes for our patients. I will let Pharis to show the detailed data, but suffice to say that they are consistent with the efficacy and safety seen after longer treatment periods in our prior studies, i.e., more patients respond and overall, they respond more and they respond better. You will recall that we also observed statistically significant improvement in efficacy measures in our 3-year open-label extension data in children 4 to 11 years of age. And that was presented at the AAAAI Annual Meeting of 2020 and published in The Journal of Allergy and Clinical Immunology known as JACI, as you know, also in 2020. Now there are many highlights to this new data set in toddlers. What is particularly striking to me is that among on-treatment subjects from EPITOPE who continued in this open-label extension study, after 2 use treatment, 3 out of 5 subjects completed the oral food challenge at a cumulative equivalent of 12 to 14 peanut kernels without triggering up stopping symptoms. Beyond what could be anticipated during an accidental exposure and something that has the potential to be rather transformative to the life of these families. Another key finding from open-label extension study was the consistent safety and tolerability profile in this younger toddler age group. And as Pharis will highlight later, safety findings were observed to be improved in a second year of treatment with Viaskin Peanut in this open-label extension study. We have made significant strides forward in our Viaskin Peanut Toddlers development program since last year, and we are excited about its potential to help toddlers with peanut allergies and through that also greatly benefit their families and their loved ones. We decided to share this interim analysis data Viaskin Peanut in toddlers with you, and I invite Pharis told you detail.

Thank you, Daniel. Before diving into the open-label extension data, let's take a moment to revisit the results from EPITOPE, the pivotal Phase III 12-month efficacy study conducted in toddlers ages 1 to 3 years. I think this will help to put the new data into better context. Recall that this study used the original square Viaskin Peanut patch. The study was published in the New England Journal of Medicine last May. The EPITOPE study had 244 subjects randomized to daily treatment with Viaskin Peanut and 118 subjects randomized to placebo. There was a double-blind, placebo-controlled food challenge at baseline as part of the study entry criteria and again, at the end of the study at month 12. Subjects were considered treatment responders if they reached an eliciting dose of at least 300 milligrams or about 1 peanut if the baseline eliciting dose was 10 milligrams or less, or if they reached at least 1,000 milligrams if the baseline eliciting dose was between 30 and 300 milligrams. 67% of the subjects in the Viaskin arm met the treatment responder criteria after 12 months. This compares to 33.5% of subjects in the placebo arm. The predefined endpoint was achieved with a lower bound of the 95% confidence interval being 22.4%, which was well above the prespecified 15% mark. As we've previously announced, the FDA confirmed that the EPITOPE study met the prespecified criteria for success for the primary endpoint, and the FDA did not ask for additional efficacy data for this age group. Following the conclusion of the 12-month treatment period, eligible subjects were able to enroll into the open-label extension for up to 3 years of total treatment. The subjects randomized to active treatment in EPITOPE could receive an additional 2 years of treatment in the open-label extension and subjects randomized to placebo in the EPITOPE study could cross over to receive 3 years of active treatment. We have always prioritized making Viaskin Peanut available to our study subjects for multiple years beyond the primary endpoint of a given study. As we feel strongly that this is how our product will be used if it is approved. The open-label extension to EPITOPE is called EPOPEX. Notably, subjects or rather their parents and caregivers, we're still blinded to the randomized arm and to the food challenges during EPITOPE. So there was minimal bias when making the decision to enter the open-label extension. Let me start by reviewing the subject disposition. As we previously published in the New England Journal of Medicine, 244 subjects were randomized to the active arm of EPITOPE with 208 completing the study, 36 subjects, 14.8% did not complete EPITOPE and were, therefore, not eligible to participate in the open-label extension. Most of them were clinical failures, and of course, these subjects were still included in the efficacy and safety evaluation results that I discussed a minute ago. 85% of eligible subjects that is 175 of 208 entered the open-label extension and 95% participated in the double-blind placebo-controlled food challenge at month 24 of treatment with Viaskin peanut. Viaskin Peanut is intended to be a long-term therapy. As you will see, staying on therapy for a second year shows higher response rates and a progression to higher eliciting doses. It is also important to us to capture the factors behind the minority of families and caregivers who chose not to participate in the open-label extension. As is the case in many open-label extensions, real life gets in the way of the rigors of a clinical trial. Roughly 1/3 of parents stated that they were too busy or moving to a new state or feared COVID-19, for example. What particularly importance to us, only one subject listed fear of the food challenge as the reason for not participating in the open-label extension. This is clearly lower than what we observed in our previous 4- to 11-year-old open-label extension study, reinforcing what we heard from many KOLs and investigators, which is that food challenges are generally easier and less stressful with toddlers than children. This is an important factor as we prepare to initiate our COMFORT Toddler supplemental safety study in Q1 next year, where we chose to include a double-blind, placebo-controlled food challenge as part of the inclusion criteria to ensure we can enroll a similar population relative to EPITOPE. Also of note, only 4 subjects discontinued because of patch wear or skin irritation. This is very much aligned to the low discontinuation rate we have seen in all our other pivotal studies with Viaskin Peanut. We also see that for 17 subjects, about 8% of the eligible subjects, their parents or caregivers wanted to introduce peanuts to their toddlers diet, or they wish to try other forms of immunotherapy often because their child is [indiscernible] allergic. This echoes what we see in our market research. Many families seem to understand that greater benefits are likely to come from being on therapy for many years, while a minority want a form of closure sooner than that. Similar disposition percentages were observed for the subjects randomized to the placebo arm of EPITOPE. 92% of eligible subjects that is 91 of 99, entered the open-label extension with 86% participating in the double-blind placebo-controlled food challenge at month 12 of treatment of Viaskin Peanut. The disposition pattern and reasons for discontinuation with placebo were similar to what we observed in the active treatment arm. The 175 and 91 subjects presented in the open-label extension cohorts that is subjects receiving 24 months and 12 months of Viaskin Peanut treatment, respectively, are a subset of the subjects presented in the EPITOPE 12-month results, this is because of dropouts, incomplete food challenges and other reasons. Okay. Now let's look at the 12-month open-label extension data for subjects originally randomized to Viaskin Peanut. Subjects in this arm had a total of 2 years or 24 months of treatment with Viaskin Peanut. Using the same primary endpoint definition that was used in EPITOPE, 83.9% of subjects who completed the double-blind placebo-controlled food challenge met the responder criteria after 24 months. This compares to 67% of subjects after 1 year of therapy. After 1 year of treatment with Viaskin Peanut in the EPITOPE study, approximately 1/3 of subjects completed the food challenge without meeting the stopping criteria at the highest dose of 2,000 milligrams with a cumulative food challenge dose of 3,444 milligrams. Following an additional year of treatment in the open-label extension, more than half of the subjects, 55.9% were able to complete the entire food challenge without meeting the stopping criteria. So almost 56% of subjects consumed the equivalent of about 12 to 14 peanuts, way beyond the amount that would likely be encountered during an accidental exposure. And remember, the median eliciting dose at entry was 100 milligrams for the epitope study population. We have just seen the percentage of subjects that met the EPITOPE responder criteria, it's sometimes easier to put these results into a different context. Here, we see that 81.3% of Viaskin Peanut subjects reached an eliciting dose of greater than or equal to 1,000 milligrams relative to 64% after 1 year of treatment observed in epitope. Similarly, the percentage of subjects with an eliciting dose greater than or equal to 2,000 milligrams, the highest dose in the food challenge, increased from 37% after the first year to 64% following an additional 1 year of treatment. We also assessed the 4 efficacy parameters that I presented on Slides 8 and 9, just for the cohort of 175 EPITOPE subjects that chose to enter the open-label extension and not for the entire EPITOPE active treatment arm. Assessing efficacy after 12 months of treatment in just the subjects that completed EPITOPE and entered into the open-label extension allows us to get a sense of how much further improvement occurred with the additional 1 year of treatment in the open-label extension? This data is not presented in the slides but it is in the press release. It is important to note that efficacy response observed in the open-label extension continues to improve and this is the best approach to determine by how much since it is largely the same cohort of subjects. So let me tell you about this data. At month 12, 77.4% of subjects met the EPITOPE responder definition relative to 83.9% of subjects at month 24. For subjects that completed the cumulative 3,444 milligram food challenge without meeting stopping criteria, the numbers were 39.5% and 55.9%, respectively, at month 12 and 24. At month 12, 74.7% reached an eliciting dose of greater than or equal to 1,000 milligrams relative to 81.3% million at month 24. And at month 12, 52.4% reached an eliciting dose of greater than or equal to 2,000 milligrams relative to 63.8% at month 24. We believe these data demonstrate a robust continued treatment effect with Viaskin Peanut. The percentage of responders increased from months 12 to 24 for all efficacy parameters. We believe that this data shows that Viaskin Peanut, if approved, may provide a treatment option for this population with a very high unmet medical need. Let's move now to safety and tolerability. No new safety signals were observed, and findings were generally similar to what was reported during the first year of treatment. Overall, safety and tolerability with Viaskin Peanut continues to be consistent in our toddler data as it was relative to our 4 years and older subjects. Local application site reactions continue to be the most reported adverse event with frequency decreasing during the second year of treatment. The frequency of treatment-related adverse events also decreased in year 2 relative to year 1. There were no treatment-related serious adverse events reported during the second year of treatment. And as was the case during the first year of treatment with Viaskin Peanut, no treatment-emergent adverse events led to permanent study discontinuation. Finally, no treatment-related anaphylactic events were observed in the second year of treatment. This interim analysis also includes subjects originally randomized to the placebo arm of epitope who then crossed over and received active treatment with Viaskin Peanut for 1 year in this open-label extension. As we expected, the efficacy and safety results in the crossover arm were consistent with what we observed in the active arm of the EPITOPE study. 68% met the responder criteria, which is essentially the same as the 67% from the first year of epitope. 28.4% of subjects completed the food challenge without meeting stopping criteria relative to 30.7% in EPITOPE. 62.7% reached an eliciting dose of greater than or equal to 1,000 milligrams relative to 64.2% in EPITOPE and 36.5% reached an eliciting dose greater than or equal to 2,000 milligrams relative to 37% in epitope. Similar to the 1-year EPITOPE safety data, there was a single event of treatment-related anaphylaxis that occurred in year 2. This is during the 12 months of active treatment. We believe these data further confirm what we observed during the first year of treatment in the epitope STUDY. In addition, it confirms that treating 2- to 4-year-old that is subjects that were at least 2 years old before starting Viaskin Peanut to treatment effects, which we believe bodes well for our ongoing 4- to 7-year-old efficacy and safety study, the test. Let me now summarize the key findings from this 1-year interim analysis of the open-label extension to EPITOPE. 81.3% of subjects were able to achieve an eliciting dose of greater than or equal to 1,000 milligrams following an additional year of treatment and 55.9% of subjects completed the entire food challenge of 3,444 milligrams without meeting stopping criteria. With an additional year of treatment with Viaskin Peanut, the percentage of treatment responders increased to almost 84% when applying the EPITOPE month 12 responder criteria. The safety profile remained consistent relative to the first year and relative to the older 4- to 11-year-old safety data, no new safety signals were identified. The placebo crossover group had results that were nearly identical to that of the original EPITOPE active treatment arm, thus we believe it confirms the consistency of the EPITOPE results. We firmly believe that these data continue to build upon the original EPITOPE results in toddlers 1 to 3 years of age, for which there is currently no FDA-approved treatment. At this point, I'll pass the call back to Daniel. Daniel?

Thank you, Pharis. We believe that these interim results are very compelling and complement the efficacy results from EPITOPE that we first announced in June of 2022, in which were featured in The New England Journal of Medicine this past May. Simply put, we believe that continued treatment with Viaskin Peanut has the potential to be transformative to the lives of peanut-allergic toddlers, if approved. Before I conclude today's session, highlighting our next steps to our tower program, I would remiss if I did not take this opportunity to introduce you to our new Chief Financial Officer, Virginie Boucinha. Virginie?

Thank you, Daniel, and good afternoon, everyone. I'm really pleased to be on this call today as a new member of the DBV team. So by way of introduction, I'm a finance professional with more than 30 years' experience. I had the privilege to work in many businesses, mainly within the pharmaceutical sector and in several high-level global roles, where I have learned to navigate and overcome complex financial situation. I'm delighted to be joining DBV at a time where we will have to responsibly plan for launch and for success. And I see great promise not only for Viaskin Peanut, as we hope to bring this product to market, but also the potential of this innovative platform. And the results that Pharis have shared with us today further reinforce enthusiasm for joining DBV at such a critical time. So thank you, and I will hand the call back over to you, Daniel.

Thank you, Virginie, and I'm delighted to have you on the team. So we have made remarkable progress on our COMFORT Toddlers development program, which demonstrated efficacy at 12 months. And that was, as you will recall, acceptable to the FDA to support filing and that continues to significantly improve after another year of therapy, as we have shown you today, and as Pharis have detailed for us. We plan to continue that progress with anticipated start the supplemental COMFORT Toddlers study in the first quarter. Last week, we announced along with our third quarter results that we received feedback we had requested from FDA on outstanding protocol design elements for the COMFORT Toddlers trial. Now informing that we have submitted the final protocol to FDA this week. We anticipate the first subject to be enrolled in the first quarter of 2024. And as we've communicated and has been our habit, we will share more details as the trial progresses. So this concludes our prepared remarks. I will ask the operator to open the call for questions if there are any. Operator?

[Operator Instructions] The first question comes from Jon Wolleben from JMP Securities.

Congrats on the interesting data. A few for me. Wondering, I might have missed this, but did you guys release the 12-month food challenge results for the placebo patients versus the baseline rates. Just wondering if we're seeing any effect to patients just getting older and growing out of the peanut allergy, especially with the context of the improvement from year 1 to year 2, I think that's an interesting point.

I want to make sure to understand your question, Jon, are you asking whether we have placebo-controlled data for the patients who crossed over?

Yes. Just -- did the baseline levels change at all because these changes are from baseline studies coming from EPITOPE?

I understand. I'm sure - so the answer is, no. We did not announce it today. I'm sure we have that data. Pharis, you have any comments on that? I doubt that it would be fundamentally different since we have the baseline data for placebo and blinded EPITOPE, but I'll let Pharis expand and answer that question.

Sorry, Jon, I don't quite understand the question. So do we have a matching placebo arm, I apologize that...

Yes, the crux my question is, are any of these children growing out of their food allergy? And I think the best proxy for that would be the change in food challenge results from baseline and EPITOPE to a 12-month [indiscernible] EPITOPE that range because what you're measuring here, if I understand correctly, is baseline EPITOPE to year 2. So just wondering about that difference plays in at all, general growth -- outgrowth for the peanut allergy.

Yes. I think as Daniel said, we have the placebo-controlled arm at baseline where we followed them for the 12 months. And I don't think that there's a big component of that involved in the data that we're seeing. And maybe, again, I'm sorry, I still may not understand but the placebo crossover results were so clearly identical to what we saw originally in the first 12 months of epitope that we've really replicated there. So whatever we saw for the first 12 months, we've seen it again in this other arm that crossover. So I'm not sure if that exactly answers your question, Jon, but I don't think it's any different from what we presented originally in terms of you have a double-digit response to placebo with your food challenge. And then over the course of the age range from 1 to 4 to 5, you see about 20% plus natural or spontaneously outgrowing it. So again then I'm not sure if that answered your question.

It's helpful. And you guys had a longer follow-up in the older children over 3 years. What -- can you remind us of that pattern? Obviously, we're seeing improvement here from year 1 to year 2. Do you expect this to continue? And then for how long?

That's an important question. So yes, there is the third year. The difference between the open-label extension to PEPITES, which was called PEOPLE, is that we only had a month 12 and 136. We did not have a 24-month assessment. And if you remember, we saw generally sort of a 15-to-20-point improvement in response rate between months 12 and 136 in absolute response rate. In toddlers, it was important for us to have a month 24 and months 36 assessment. So you have 124 now. We will share all the same month 36 around the same time next year. Does I answer your question?

Yes. And then you guys also have looked at sustained unresponsiveness a little bit in the older population. Is that the plan here as well when you wrap up EPOPEX?

Pharis?

Yes. No, that's not currently the plan, Jonathan. We'll run the 3 years and see where we are. But right now, we don't have a plan to look at that.

And one last one, if I may. Can you give a little context around these thresholds, the 1,000 and 2,000 milligram and what that means for kind of day-to-day for these children?

Yes, I love that question because that's my -- everyone knows in the company, that's my favorite outcome measure. So it represents a 1,000 milligrams, there's about 3 to 4 peanut kernels. And you don't have to interpret that in terms of a response rate. You just know, okay, 3 to 4 peanut kernels. And the context for me that hits home is that most accidental peanut exposures take place at somewhere around 125 milligrams. And remember, these patients came in at about 100 milligrams, and you're boosting them up to 1,000. So if you think about it, for example, if you go down to your donut shop and you pick up a donut with peanut sprinkled on it and you were to take the amount of peanut off of that donut and measure it. So [ either ] it's not going to come close to 1,000 milligrams. So the point, Jonathan, is you kind of have to go out of your way to accidentally consume 1,000 milligrams worth of peanut protein. So for me, it's just a great number to be able to put into context, knowing where these patients started, where the average accidental peanut exposure takes place in terms of milligrams and then the data that we've shown here in terms of the percentage if you get to 1,000 milligrams. Does that help?

That's super helpful. And again, very impressive increases over time. Thanks for taking my questions and congrats on the data.

Thank you, Jon.

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to Daniel Tassé for any closing remarks.

Thank you, operator. So in closing, the month 24 interim results from our ongoing open-label extension study that we just announced today and that will be presented at the College's Annual Meeting this Saturday, reinforces our optimism for the potential of this treatment is approved to potentially improve significantly the lives of peanut allergic toddlers, their families and their caregivers. We look forward to progressing this open-label extension study to its conclusion month 36, while in parallel, initiating COMFORT Toddlers as we work to complete the remaining regulatory steps in support of the BLA. It concludes our call. I thank you again, and I wish you all a very good evening.