Dbv Technologies SA (DBVT) 2022 Q1 法說會逐字稿

Good day, and welcome to the DBV Technologies First Quarter 2022 Earnings Conference Call. My name is Darryl, and I will be your operator for today's call. (Operator Instructions) As a reminder, this conference is being recorded. I will now turn the call over to Anne Pollak. Anne, you may begin.

Thank you. This afternoon, DBV Technologies issued 2 press releases, one that outlines our financial results for the 3 months ended March 31, 2022, and the second that announces we have established an at-the-market or ATM program. These press releases are available in the Press Release 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 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 Daniel Tasse, Chief Executive Officer of DBV; Sebastien Robitaille, Chief Financial Officer; and Pharis Mohideen, Chief Medical Officer. Daniel will provide a business update, and Pharis rand Sebastien will join Daniel for questions at the end.

I will now pass the call over to Daniel. Daniel?

Thank you, Anne, and thank you all for joining us on this call today. Now let's start with an update on the clinical and regulatory development of our modified Viaskin Peanut patch.

As a reminder, in December, we announced our plan to initiate a pivotal Phase III clinical study with the modified Viaskin Peanut patch in children in the intended patient population. We made the decision because, in our view, conducting a pivotal trial with an efficacy assessment the fastest way to potentially bring Viaskin Peanut to their families and allergists who are anxiously awaiting additional therapies for peanut allergy.

At DBV, speed to patient is both the lens through which we evaluate all regulatory and clinical options as well as the standard by which we will measure our progress. As such, we have named the new pivotal trial VITESSE, which means speed in French and stands for Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy. V-I-T-S-S-E, VITESSE.

At the time of our last corporate update in early March, we had completed the VITESSE protocol and prepared it for submission to the FDA for their review. At that time also, we're engaged in productive exchanges with the FDA. Our conversation with the FDA continuing to march and eventually advance to a shared view that DBV should request a Type C meeting to facilitate further and more detailed exchanges. The FDA granted us a Type C meeting in the second quarter, and we look forward to their feedback on key elements of the VITESSE protocol.

Our recent exchanges with the FDA have been collaborative and timely. Our goal is align a pathway that serves peanut allergy families and allergists. And as always, we are mindful of speed to patients.

Once we have alignment with the FDA on the VITESSE protocol, which could require 1 or 2 further exchanges after the Type C meeting to clarify key protocol elements, we will provide more details of the study design and importantly, how it translates into expected time lines. We look forward to providing that update as soon as possible.

And there's also a second upcoming milestone in the clinical development of Viaskin Peanut. We expect top line results from EPITOPE by the end of Q2 of the second quarter of 2022. EPITOPE is a Phase III trial assessing the safety and efficacy of Viaskin Peanut 250 micrograms for the treatment of peanut-allergic toddlers 1 to 3 years old.

Now DBV initiated this steadily -- excuse me, initiated this study shortly after starting the PEPITES study in -- for 11-year-olds with peanut allergies. So we plan on sharing the EPITOPE top line results soon after we unblind this study. But the EPITOPE results will also inform our proposed regulatory pathway for Viaskin Peanut in children ages 1 to 3. We plan initiating an exchange with the FDA regarding the regulatory pathway in 1- to 3-year old after we have fully analyzed the data from EPITOPE.

I'd like to now spend some time putting the financial results for the first quarter of 2022 in the context of the clinical and regulatory update I just provided.

Our cash and cash equivalents as of March 31, 2020, were $74.1 million, which we expect is sufficient to support our operations while we align with the FDA on the VITESSE protocol. More precisely, we expect our cash balance will support operations into the first quarter of 2023.

That being said, DBV will need to raise money before we resubmit a modified Viaskin Peanut BLA -- should I say, before we submit a modified Viaskin Peanut BLA. A mix of financing tools done incrementally are amongst the potential options we are exploring.

Today, we announced that we have established an at-the-market, or ATM, program which is one of the financing tools we wish to have available to DBV. In a volatile market, we want every financing tool at DBV's disposal to maintain a strong balance sheet as we advance Viaskin Peanut towards potential approval. The ATM program will enable us to offer and sell DBV American Depositary Shares, or ADSs, to eligible investors from time to time.

Now the ATM documents filed with the SEC today state that DBV may sell up to $100 million of ADSs and then the program is valid until June of 2024. Now I wish to comment on these terms.

As you know, ATM programs can be time consuming and expensive to establish. We thus defined broad parameters to the DBV ATM program to maximize efficiency, the program's expenses. Now we intend to apply the same financial diligence that we have demonstrated in establishing the program as we actually make use of the program. And as we've discussed, we are also exploring non-dilutive financing strategies that could leverage Viaskin Peanut's significant commercial potential among other options for financing.

Our current stock price, in our opinion, does not reflect the significant potential of the Viaskin platform. The good news is that we have time to explore all available financing options and select the one tool or combination of tools that best fits our corporate strategy and circumstances at the time. We will keep you updated on our progress.

So there are 2 near-term DBV catalysts on the horizon: FDA alignment on the VITESSE protocol is one. And the other is the EPITOPE top line data. We will, of course, issue a press release for each development. And after each announcement, we will host a conference call to review the news in more detail and take any questions.

Now given the timing of each, it is likely that DBV will host at least one conference call and possibly 2 before release our first half of 2022 financial results, which are currently targeted for early August. I look forward to providing those updates when appropriate for the next several months. I want to thank everyone on the phone and webcast for joining us today.

And operator, let's open up the line for questions, please.

(Operator Instructions) And our first question comes from Jon Wolleben.

Congrats on the progress. I know previously, you've discussed a protocol similar to what you did with PEPITES. I was wondering if you could tell us any more about the broad strokes of the protocol you submitted to the FDA ahead of the Type C meeting.

Yes. We're looking forward to sharing absolutely extensive details on the protocol, Jonathan. We'd rather get the alignment with the FDA first. We know what we wish to do. The FDA has seen already 3 -- sorry, 2. This is the third pivotal study they've seen from us, PEPITES being the first one and EPITOPE the second one.

We don't expect it's going to be a particularly difficult discussion given the fact that this has been done before, but we'd rather finalize the protocol. And with that alignment, then share all the details with investors. We think that's just a healthier process.

And I think I heard in your prepared comments, you envision there could be 1 or 2 interactions after the Type C meeting. Wondering why you're thinking that those may be necessary.

Well, they may not be necessary. We just trying -- again make sure that we're as fulsome of communication here with investors. The Type C meeting will provide all the answers we need, but it may be necessary to go back to the agency and make use of what's been a very healthy dynamic with them and make sure that everything is really buttoned down.

As we've mentioned, Jonathan, repeating pivotal trial in the these targeted population of children over the age of 4 is repeating PEPITES. So we think that we have very good insights around clinical profile, what I call the clinical risk and study execution risk.

What we think is also important is that we minimize as much as possible what we call regulatory risk or possibility of not full alignment with the FDA, which is why we're prioritizing that. And if there's a need to make sure that every last detail is well aligned before we move forward, we believe that would serve the process well. That will be in the interest of speed at the end of the day.

Got it. And maybe last couple on EPITOPE, looking forward to that data. Can you walk us through your expectations on assumed success what this looks like in an environment where you might have EPITOPE looking good with the original patch, but then you're moving forward with the older children with the modified Viaskin patch?

Is there going to be some sort of bridging work to have just one? Or is there a world in which you have 2 different patches out there? Can you just walk us through those different scenarios and how you're thinking about it today?

Yes. We are comfortable considerably with 2 different patches, the what we call cVP in one population, mVP in an older one. But yet here, I'm simply speculating, Jonathan. Until we have the results of the study and we talk to the FDA, at this point in time, I'm just suggesting what is obviously DBV's perspective on this. Obviously, that of the FDA is essential.

And the beauty of our ability to answer their question will be just having data on hand, showing what is the profile of the studies. EPITOPE was designed around lines are very similar to those that is around patient stratification, clinical response and everything else. So again, we think our ability to take the EPITOPE results and engage, we think, a fruitful discussion with the FDA and what it may mean as a regulatory pathway is something that will be relatively straightforward to do.

But once we have the data in hand, we don't have it right now. So I'd rather again not speculate. But our comfort of having 2 patches out there is [tied]. Has a manufacturing issue, that's not the question. Obviously, we want to make sure we work hand in hand with the regulators.

(Operator Instructions) And we have no further questions at this time.

Operator, we thank you. We thank everybody who attended today and wish you a very good week.

And thank you. Ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now disconnect.