Good day, everyone, and welcome to the DBV Business Update 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 and then one on your telephone keypad. To withdraw your question, please press pound one. Please note this call is being recorded. Now, I would like to turn the conference over to Jonathan Neely, Investor Relations. Please go ahead.
Thank you. This afternoon, DBV Technologies provided a regulatory update for the VIASKIN Peanut patch for children aged four to seven years. This update 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, 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 is Daniel Tassé, Chief Executive Officer of DBV. I will now pass the call over to Daniel. Daniel?
Thank you, Jonathan, and thank you all for joining us today. As mentioned in our press release this afternoon, over the recent weeks, DBV has been having ongoing conversations and exchanges with the FDA regarding elements of our BLA, with the intention of ensuring a complete, efficient, and timely review for upcoming Biologics License Application, the BLA, for the VIASKIN Peanut patch in children aged four through seven years of age. These extensive detailed conversations with the FDA are the kind of exchanges a sponsor would anticipate following submission of a BLA. They have been especially valuable for a novel, unique, and complex product like the VIASKIN Peanut patch that requires a similarly unique and complex submission package. To be clear, the FDA has not requested additional data. DBV and the FDA have collaborated through a series of iterative meetings, information exchanges, and filings for the VIASKIN Peanut IND.
Based on its review, DBV received valuable, actionable input from the FDA specific to the organization, mapping, and formatting of existing data sets for the CMC section, as well as biostatistical elements of the BLA. To provide some context for these exchanges, as we all know, the VIASKIN Peanut patch is a unique and first-of-its-kind drug-device combination, which will be reviewed and approved as a biologic, and therefore sits at the intersection of many sets of regulations. There is no analog for VIASKIN Peanut. We have charted this regulatory path working closely with the FDA along the way, and we're grateful for their feedback and interaction.
To give you an example, given the size and overall complexity of our submission, topics have been, in parts, been focused on ensuring the completeness of the BLA, as well as identifying and mapping the location of data within the BLA to help the agency with the efficiency of their review. We are grateful for the FDA's constructive engagement at this stage of the work and believe by taking the required time to incorporate their feedback, we will strengthen our BLA submission. We plan to submit our BLA in the third quarter this year. Sorry, I skipped a page of my script here. No, sorry. My apologies. The need for new treatments for children and families living with the daily burden of peanut allergies is significant, we feel a profound responsibility to advance the VIASKIN Peanut patch as thoughtfully and efficiently as possible.
With this feedback in hand, I look forward to optimizing our BLA submission and moving with urgency towards our goal of bringing VIASKIN Peanut patch to patients who need new treatment options. I'd be happy to talk to you more about the nature of the feedback we received from the agency and answer your questions. I'll now pass it on to the operator for the Q&A.
If you'd like to ask a question, please press star one on your phone now, you'll be queued in order. Again, star one for a question, we'll pause briefly. Our first question today comes from Kristen Kluska, Cantor Fitzgerald.
Hi. Thanks so much for taking my questions. The things you mentioned today typically sound like the things that arise in the middle of a regulatory submission. On one end, very good to iron this out now versus have it delay things down the line. I'm just curious why the level of conversations were so detailed at this stage before the formal submission. Is this in part based on the designations on hand you've seen, or any color there would be really helpful.
No, absolutely. The conversations have been very rich with the agency for many months now. When the complexity of the BLA, given the fact that, again, it has no analog, became something that the agency wanted to make sure that their review was efficient, the dialogue started to make sure that everything that matters to the FDA was in the BLA, and importantly, easy for them to find. You probably know that a lot of time is spent by the FDA trying to find documents in a BLA. The idea here was to work with them to make sure all of it was structured, mapped, and easy for them to find, and to make sure it was complete. You're correct. Typically, these conversations would take place post-filing. We very much welcome the fact that we've had these conversations prior to filing.
Does that answer your question, Kristen?
Yes. Thank you. Are these factors also going to play into your BLA filing for the one to three-year-olds when that occurs? Is there any other feedback or things that you can collect that are going to help with that process so that once that one is in good shape, maybe the meetings subsequently with the FDA will have already occurred as part of this four to seven-year-old submission?
That's an excellent question. The answer is yes. We expect that the conversation we've had right now about how to build the best BLA for the FDA to be able to review it efficiently in a timely way is going to make us a lot smarter as we put together the BLA in one to three-year-olds. As you appreciate, there's nothing that looks like our product. There's no analog. We're building this along the way here. Dialogue with the agency on four to seven obviously will make us smarter and faster in putting the BLA together for the one to three.
Okay. Thanks so much, Daniel.
Thank you.
Next, we'll hear from Sushila Hernandez of Kempen Investment Banking.
Yes, thank you so much for taking my questions. Do you still expect that the BLA may be eligible for Priority Review, or what is your latest thinking here?
Yeah, we are. Thank you, Sushila, for your question. We have Breakthrough designation, and thus we are eligible for Priority Review. Our plan is to ask for it. Obviously, the work that we're doing right now will make that, under any timeframe, the review by the agency to be facilitated here. Our plan is to ask for it. As you know, we get the answer at day 60 post-filing.
Okay. Then in terms of timelines for incorporating the feedback from the agency, will this be a matter of days or months to finalize it? Is it something that you've already been working on and just cutting it close to your own deadline?
Yeah. We are pretty rigorous with Gantt charts and planning at DBV. It's sort of an operational focus of us. All of this feedback from the agency has been mapped out. A lot of it can be done in parallel, obviously. We will be filing in Q3. We have a very clear plan to get it done and a clear date in mind. At this point in time, we're guiding to Q3. What I think anybody involved in filing a BLA can appreciate there's not only the changes the FDA is asking us to do, but there's a domino effect. We have to make sure that as we change something in one place in the BLA, another table or listing that essentially is connected to it will also be affected. The element of QA/QC, if you make a change, is significant.
The e-publication of a BLA, just to go through the portal alone at the agency takes a few days, given the size of the file and the need for all the proper firewalls here. All that to say, all of that has been mapped out and Gantt charted very closely.
Okay. There are no issues with the manufacturing sites that you've been contracted. It's really more about mapping out the information that you already have.
That's exactly it. The FDA has not received the BLA yet, they want to make sure that once they do get the BLA, all the things that matter to them are there, and that they can find them and find them easily, along, as you can imagine, there's a number of sort of sister and domino documents that come with the BLA to make sure it's easy to access for the FDA.
Okay, that's clear. Thank you.
Does that answer your question?
From LifeSci Capital, we have Sam Slutsky.
Hey, thanks for the update call. This is Goran for Sam. Can you give color on the specific feedback the FDA wants you to incorporate in the BLA filing for four to seven-year-olds that wasn't there prior? Could their information request potentially change the interpretability of the clinical results?
Great question. Let me start with the latter question. The answer is no, simply because the FDA has not seen the content of the BLA. The questions we got from them, and their suggestions are not reactions to data in the BLA and interpretations here. No, the changes we're making are not meant to address observations about the content of the BLA, the interpretation of it. This is simply to make sure that all the data the FDA needs is structured in a way that's easy for them to review and easy for them to trace. That's essentially the comments we got from them. No, there is nothing in there that would impact, at least they haven't reviewed the BLA, none of the exchanges were about content or interpretability of the BLA. Is that helpful?
Okay. Yeah. Very helpful. You answered my follow-up, thank you.
Happy to help.
Once again, everyone, to ask a question, press star one. We'll proceed with Jon Wolleben of Citizens JMP.
A couple from me. Just wondering, without knowing the true context or size of these changes, any chance that this could get pushed to Q4 or is this going to be relatively easy to maneuver through?
You asked whether or not it could go into Q4? Is that your question?
Yes. Yep.
I'm sorry. I think you broke up there. The answer is no. Obviously, we have to do the work. You never know what surprise could come along the way here. We have been very precise in mapping out the work we need to do, what it means. Our guidance is Q3.
Okay. With COMFORT Toddler, you guys have been guiding the submission second half of the year, six-month study. I don't think we've heard of enrollment completing there. Any update on COMFORT Toddler's enrollment and the timelines for that BLA submission?
Yeah. COMFORT Toddler is enrolling as planned. Our guidance remains for us to file the BLA in one to three before the end of this year. Conversations with the agency on how to think about that have been ongoing.
Okay. All right. Thanks.
We have no further questions at this time. Daniel, back over to you for any additional or closing comments.
Okay. Well, thank you. This concludes our call this afternoon. Again, we're very pleased with the progress we've made. We are delighted with the feedback from the agency and remain very committed, obviously, to filing the product as soon as possible as to help transform the lives of children and families who live with the daily burden of peanut allergy. Thank you so much.