Q1 2022 DBV Technologies SA Earnings Call

I will be starting in just about five minutes once again, thanks for standing by we'll be starting in five minutes.

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Welcome to the <unk> technologies first quarter 2022 earnings Conference call. My name is Daryl and I will be your operator for today's call. At this time all participants are in listen only mode. Later, we will conduct a question and answer session. During the question and answer session. If you have a question. Please press star zero.

One on your Touchtone phone as a reminder, this conference is being recorded I will now turn the call over to Anne Pollock and you may begin.

Thank you.

This afternoon DVD technologies issued two press releases, one that outlines our financial results for the three months ended March 31, 2022, and the second that announces we have established an aftermarket or ATM program.

These press releases are available in the press release section of the DVD 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 a car.

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 Anr 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 Zhang Chief Executive Officer of DVD, Sebastian Robotize, Chief Financial Officer, and Sarah Smoothing Chief Medical Officer.

Daniel will provide a business update and Paris, and Sebastian will joined Daniel for questions at the end.

I'll 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 our clinical and regulatory development of our modified Baskin peanut patch.

As a reminder, in December we announced our plan to initiate a pivotal phase III clinical study for the modified peanut.

Patching children in the intended patient population.

We made the decision because you know you can.

Dumping a pivotal trial with an efficacy assessment, the fastest way to potentially bring Bryan skin peanut to the families and allergists are anxiously awaiting additional therapy for peanut allergy.

At BBB.

Speed to patient is both the lens through which we evaluate all regulatory and clinical auctions as.

As long as the standard by which we will measure our progress.

As such we have been named the new pivotal trial, the pets, which means speed in French and stance.

For Zions skin peanut immunotherapy trial to evaluate safety simplicity and efficacy.

U S S E T paas.

At the time of our last corporate update in early March we had completed the beta test protocol and preparing for submission to the FDA.

For their review.

At that time also engage in productive exchanges with the FDA.

Our conversation with the FDA continue into March and eventually advance to a shared view.

The Dbz should request a type C meeting.

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 still on a path to weird that serves peanut allergy families and allergists and as always we are mindful of speed to patients.

Once we have alignment with the FDA under the test protocol, which could require one or two 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 timeline.

We look forward to providing that update.

Soon as possible.

And there's also a second upcoming milestone in our clinical development of biased in peanut.

We expect topline results from epitope by the end of Q2 of the second quarter of 2022.

Epitope as a phase III trial, assessing the safety and efficacy of ice can peanut 250 micrograms for the treatment of peanut allergic toddlers.

One to three years old.

<unk> initiated this steadily Sydney and you should study shortly after starting the Petite study and 411 year olds with peanut allergies.

So we plan on showing the epitope topline resolved soon after we unblinded study.

But the epitope results will also inform our proposed regulatory pathway for bias can peanut in children ages one to three.

We are initiating an exchange with FDA regarding the regulatory pathway and one to three year old after we have fully analyze 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.

Provided.

Our cash and cash equivalents as of March 31, 2022 were $74 $1 million.

Which we expect is sufficient to support our operations, while we align with the FDA on the test protocol.

More precisely we expect our cash balance will support operations into the first quarter of 2023.

That being said.

D BV will need to raise money before we resubmit a modified <unk> peanut BLA should I say before we submit a modified base can be an IPO.

That makes the financing tools, then incrementally are amongst the potential options we are exploring.

Today.

We announced that we have established an aftermarket or ATM program.

Which is one financing tools, we wish to have available to BBB.

In a volatile market, we want every financing due at <unk> disposal to maintain a strong balance sheet as we advance pricing peanut two.

Words potential approval.

The ATM program enable us to offer and sell Dbz American depository shares or two.

To eligible investors from time to time.

The ATM documents filed with the FCC today state the Dbz may sell up to $100 million of ABL.

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 just defined broad parameters.

Improved ramp to maximize efficiency the program expenses.

Now we intend to apply the same financial diligence that we have demonstrated and establishing the program.

As we actually make use of the probe.

And as we've discussed.

We're also exploring.

Non dilutive financing strategies that could leverage the vast and peanut significant commercial potential.

On other options for financing.

Our current stock price in our opinion does not reflect the significant potential of the bias and platform.

The good news is that we have time to explore all available financing options and select the one tool will combination of tools that best fits our corporate strategy and circumstances at the time.

We'll keep you updated on our progress.

So there are two.

Near term DVD catalysts on the horizon.

FTE alignment on the VITAS protocol.

It was one and the other is the epitope topline data.

We will of course issue a press release for each development and after each announcements we will host a conference call to review the news in more detail and take any questions.

But given the timing of each it is likely the DVD will host at least one conference call and possibly to.

Before we release, our first half of 2022 financial results, which are currently targeted for early August .

I look forward to providing those updates when appropriate with next several months.

Yes, 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.

If anyone has a question. Please press zero one on your Touchtone phone once again, if you have a question Zach.

Zero one on your Touchtone phone.

And our first question comes from John While again go ahead John .

Thank you and congrats on the progress.

Previously you've.

Hi, Danielle.

You've discussed.

Our protocol similar to what you did with the piece I was wondering if you could tell us anymore about the broad strokes.

The protocol, we submitted the FDA ahead of the type C meeting.

Yes, we're looking forward to sharing absolutely extensive details on the protocol is the only thing we'd rather get the alignment with the FDA person, we know what we wish to do.

The FDA has seen already three it's already too. This is the third pivotal study they've seen from us could teach them. The first one and epitope. The second one we don't expect it's going to be.

Particularly.

<unk> discussion given the fact that this has been done before but we'd rather finalize the protocol and would that alignment then share all the details with investors, we think thats just the healthier process.

And I think I heard in your prepared comments you envision there could be one or two interactions after the type C meeting.

Wondering why your <unk>.

Thinking that those may be necessary.

Well they may not be necessary, just trying to again make sure that we're as fulsome, our communications here with the with investors.

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 what you're putting down as we've mentioned Jonathan.

Repeating.

The pivotal trial in the targeted population of children under the age of four.

Repeating the pizza, we think that we have very good insights around the clinical profile, what I call the clinical risk and steady execution risk, but we think it is also important is that we minimize as much as possible what would call regulatory risk or possibility of not full alignment with the FDA, which is why we're prioritizing that.

New business and need to make sure that every last detail is well aligned before we move forward. We believe that would sort of the process that would be in the interest of speed at the end of the day.

Got it and maybe last couple of epitope looking forward to that data.

Can you.

Walk us through.

<unk>.

Your expectations.

<unk>.

Assume success, what this looks like.

An environment, where you might have epitope looking good what the original patch because you're moving forward with the older children with a modified guys can patch.

Is there going to be some sort of bridging work to have just one or is there.

A world in which you have two different patches out there can you just walk us through those different scenarios and how youre thinking about it today.

Yes, we.

We are comfortable conceptually with two different patches.

You will be called CVP in one population MVP is an older one big hit here I'm simply speculating comments and 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 BBB perspective on this.

We see that of the FCA is is essential.

And the beauty.

Our ability to answer the question will be just have this data in hand showing.

What is the profile of the.

This study.

<unk> is designed around lines are very similar to those of <unk>.

Around patient stratification clinical response and everything else.

So again, we think our ability to take the epitope results and engage you think a fruitful discussion with DFT what it may mean is a regulatory pathway.

Is something that will be relatively straightforward to do good once we have the data we don't have it right now so I'd, rather again, not speculating, but our comfort.

Having two patches out there besides has a manufacturing issue that's not the question obviously, we want to make sure that we work hand in hand with the regulators.

Fair enough makes sense, thanks again for taking the questions.

So welcome.

And once again if anyone has a question you can press zero one on your Touchtone phone once again, that's zero one to ask a question.

Once again that zero wanted to ask questions.

And we have no further questions at this time.

So operator, we thank you.

We thank everybody in attendance today.

And wish you very good week.

And thank you ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.

Sure.

Okay.

Okay.