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

Good day, and welcome to the DBV Technologies Regulatory Update Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Anne Pollak, Head of Investor Relations. Please go ahead.

Thank you. This evening, DBV Technologies issued a press release detailing feedback that the company received from the U.S. Food and Drug Administration pertaining to its ongoing development program for Viaskin Peanut in toddlers 1 to 3 years old. This press release is available in the Press Release section of the DBV Technologies website. Before we begin, please note that today's call may contain a number of forward-looking statements, including but not limited to comments regarding our clinical and regulatory development plans, the timing and results of interactions with regulatory agencies, designs of the company's anticipated clinical trials, safety studies and human factor studies, the timing and anticipated results of interactions with regulatory agencies -- sorry for that again and the company's estimate of its cash and cash equivalents as of March 31, 2023. Also we are including our forecast of our cash runway and the ability of any 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 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 today's call are Daniel Tasse, Chief Executive Officer of DBV; and Pharis Mohideen, Chief Medical Officer. I will now pass the call over to Daniel. Daniel?

And thank you, and thank you all for joining us on this call for what is an important update on Viaskin Peanut. And as you all know, in June of last year, we announced the top line results of EPITOPE in peanut-allergic children ages 1 to 3 years old. As you know, it's an important population, not simply because it's a large epidemiology, but it's also given that there's no approved product for that population and it's between the age of 1 and 4, that is a typical age of diagnosis for peanut allergies in children. So it's an important population. We submitted a pre-BLA Meeting request to the FDA in February to explore the potential approval of Viaskin Peanut in that toddler population. And we're happy to share with you the feedback from the agency that we received recently that provides the guidance we needed to outline the clinical regulatory pathway for Viaskin Peanut in 1 to 3 year olds. And I wish to come back to that in a few moments. So first, I want to highlight a fundamental component of the feedback, and it is significant. As you can see on the picture here, of our 2 patches, Viaskin Peanut for 1 to 3 year olds, the original patch, the round patch and Viaskin Peanut for 4 to 7 year olds, the modified patch are 2 distinct product candidates on independent regulatory pathways that each of the rest are high unmet needs. These are 2 distinct BLAs. And I think it's important to keep that in mind. In the moment, I will ask Pharis to provide additional details about the FDA response we received. And to summarize, the agency confirms that our Phase III EPITOPE study in toddlers ages 1 to 3 met the prespecified criteria for success with the primary efficacy end point, and thus the agency did not request an additional efficacy study. And I wish to recall what were the results of EPITOPE that we ended last June. In that study, the original Viaskin Peanut patch demonstrated a statistically significant treatment effect with 67% of subjects in the Viaskin Peanut arm meeting the treatment response criteria after 12 months as compared to 33.5% of subjects that were in the placebo arm. The P-value was less than 0.001. And importantly, the delta to placebo of the lower bound of the confidence interval was 22.4%, beating the ultimate statistical test, the prespecified 15% required by the agency. These results are particularly compelling, we consider that there is a growing body of evidence demonstrating additional benefits come to patients for commencing treatment for peanut allergy at a younger age. And the FDA is requesting that we generate additional safety data with the original Viaskin Peanut patch in this age group. Therefore, we intend to conduct a safety study to bring the total safety database in 1 to 3 rows closer to 600 patients on active treatment and that Pharis will expand, that is what the FDA has been guiding pretty consistently because of the safety database in this population. So we are very pleased that now have a well-defined path forward to a BLA submission for a toddler program, a vulnerable population with a significant unmet medical need. I will now hand over the call to Pharis Mohideen, our Chief Medical Officer, to provide you all additional details. Pharis?

Thank you, Daniel. As Daniel indicated, we are very pleased that the FDA confirmed that the efficacy results from our Phase III EPITOPE trial using the original Viaskin Peanut patch in toddlers ages 1 to 3 years old can support a BLA. This is critical as the FDA did not request an additional efficacy study for this BLA. Briefly recapping the EPITOPE results, which we announced in June of 2022, Viaskin Peanut demonstrated a statistically significant treatment effect with 67% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months. This compares to 33.5% of subjects in the placebo arm. A treatment responder was defined as either a subject with a baseline eliciting dose of 10 milligrams or less who reached an eliciting dose of 300 milligrams or more of peanut protein at month 12 or a subject with a baseline eliciting dose greater than 10 milligrams who reached an eliciting dose of 1,000 milligrams or more of peanut protein at month 12. The eliciting dose was determined using a double-blind, placebo-controlled food challenge administered at baseline and month 12. In an additional prespecified efficacy analysis, we looked at patients who achieved an eliciting dose of 1,000 milligrams or more of peanut protein regardless of baseline eliciting dose. Using this response criterion, the original Viaskin Peanut patch also demonstrated a statistically significant treatment effect with 64.2% of subjects in the treatment arm, meeting this treatment responder criterion after 12 months as compared to 29.6% of subjects in the placebo arm. The P-value here was less than 0.001. So again, we view the efficacy results from EPITOPE to be very strong, and we are pleased that the agency has not requested an additional efficacy study. Turning now to the safety study that Daniel mentioned, the FDA requested a safety study in 1 to 3 year olds using the original patch. This study will not require a food challenge as part of the design. Our experience in 4 to 11 year olds is that safety studies recruit faster than 12-month efficacy studies that require food challenges, and we expect this safety study to follow that faster recruitment trend. Upon completion, this study will bring our safety database in 1 to 3 year olds, close to 600 subjects on active treatment. The size of the safety database is consistent with the 4-to 7-year-old peanut development program, which uses the modified patch. This new safety study will also assess patch adhesion performance with updated instructions for use that aligns with the methodology agreed with the FDA for the VITESSE Phase III study. We will work with the FDA on the design of this safety study, which we believe will be very similar to the safety study we completed in 4 to 11 year olds, which was called REALISE. We anticipate submission of a protocol to the FDA by the end of the second quarter this year. In addition to the safety study, we will also conduct a human factors study with the original Viaskin Peanut patch to assess the user interface in the intended age group. We have conducted a preliminary pilot human factors validation study, and we'll use the information generated as the basis for the final human factors validation protocol. This protocol will require FDA review and alignment prior to initiation. In parallel, we continue to progress the chemistry manufacturing and controls or CMC sections of the BLA. The data generated from these studies will add to the significant body of evidence that we have already compiled with the original Viaskin Peanut patch. We will work diligently with the FDA on alignment of these remaining studies so that we can potentially bring this new treatment option to peanut allergic toddlers and their families. I'll now turn the call back to Daniel.

Thank you, Pharis. In closing, I received the feedback from the FDA provides us with a well-defined course of action for our toddler program and requires studies that we believe we can compete quickly and efficiently as we work towards the completion and submission of a BLA. As we make regulatory headway, we continue to exercise financial discipline. We've ended the first quarter of 2023 with $192.3 million in cash. The [Indiscernible] advanced its important program while in parallel executing our VITESSE Phase III clinical trial with the modified Viaskin Peanut patch in children 4 to 7. As you know, we screened our first patient VITESSE this past March, anticipate top line data from that trial in the first half of 2025. Overall, as we progress through 2023, we are advancing 2 distinct programs, both with potential to deliver significant benefits to peanut-allergic children, while also creating sustained value for our shareholders. If approved, the original Viaskin Peanut patch would represent our first commercial product, will provide critical validation of our epicutaneous immunotherapy technology that we believe has potential applications not only in other allergy indications, but potentially broader utility in autoimmune and other inflammatory disorders as well. Operator, let's open the line for questions.

And we will now begin the question-and-answer session. [Operator Instructions] Our first question today will come from Jon Wolleben of JMP Securities.

2 questions for me. Just wondering if FDA in their written responses, mentioned anything about the adhesion rates in EPITOPE and if you have to make any modifications to how you're measuring it similar to how you're monitoring invites.

So let me take the first half of that, and Pharis can add information. No, the agency is asking us to measure adhesion in the safety trial, the very same way we're going to be measuring it, tools, metrics, they'll be used and prove the test in 4 to 7 year olds, and we're pleased with that. Again, it shows consistency of the FDA's approach to this product, although they're 2 distinct patches to the same populations. The assessment of adhesion that is expected in 1 to 3 year olds is very, very similar to the one we will be performing in 4 to 7. Does that answer your question, Jonathan?

Yes. And I know you guys are going to wait for agreement from FDA on the design, but wondering, fair to assume a 1-year study here? And can you remind us of how many kids were on Viaskin Peanut, EPITOPE? And then if you will need a placebo in the safety study? Just any of those high-level details today would be helpful.

Sure, sure. Do you want to take this Pharis?

Yes, sure. John, it's Pharis. So yes, no, we would assume that this would follow similar study designs as REALISE, which was a 6-month study, 3:1 randomization -- we would also believe that it would be similar to what we would propose for the 4 to 7 year olds study. So again, the FDA had requested a safety database with patients exposed to active treatment close to 600. So if you do the math on that and you subtract out the number of active subjects from EPITOPE, which was about 260 or so in a 3:1 randomization and that would be about the size of the study that we would expect. Does that answer your question? So consistently across...

Roughly 400 patients -- give or take -- a few dozen will give us a 300 on top of the 260, taking us close to 600. But again, those numbers are not finalized and have not been blessed by the agency, but it's the ballpark. Is that helpful?

Yes, one last one for me, if I may. You gave us a cash update today and you previously were guiding the cash through the VITESSE readout in first half 2025. Wondering if a study like this was included in that prior guidance or how that might change kind of your OpEx moving forward?

Yes, our OpEx will go up. That study was not part of the guidance we gave for VITESSE -- and the guidance for VITESSE was needed due to get the dosing 4- to 7-year-old efficacy and safety done. We're in a good cash position. We obviously have 2 years of cash or more in our hands right now, so we can initiate the trial. But that study as well as the building up of the commercial organization, which will come, obviously, but the launch, we expect it's going to be not in the foreseeable future. We're not part of that guidance to be quite fair.

[Operator Instructions] At this time, we are showing no further questions. I would like to turn the conference back over to Daniel Tasse for any closing remarks.

Alison, thank you. Thank you, everyone, for joining the call. It's a bit later than we usually have it with our apologies for that. We're very enthusiastic about this response from the FDA. As Pharis mentioned, we do have to run a safety trial with adhesion measurement in about 400 or so patients. These trials are -- well, 400 is smaller than VITESSE, which is 600 to start -- and these trials are easier to recruit often shorter also than efficacy trials. So we're going to be working hard, obviously, getting to the agency. As our press release shows, we expect to be able to send them the protocol by the end of Q2 given aside the feedback from the agency was very much aligned to what has been our dialogue with them over the last little while here, 600 patients for safety, that's consistent. We made good progress on understanding adhesion performance, adhesion measurement that they want us to measure with the same way we do in VITESSE that is something we expected and makes perfect sense. So obviously, the protocol was already quite advanced sent to the agency and working for obviously providing investors and the market updates as that regulatory pathway and the specifics of those studies are being clarified. With that, I wish everybody a wonderful evening, and we'll talk to you soon.