Q3 2022 Dbv Technologies SA Earnings Call

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Welcome to the <unk> technologies third quarter 2022 earnings Conference call. My name is Carol and I'll be your operator for today's call. At this time all participants are in a 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 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 a press release that outlines our financial results for the three months ended September 32022 press release is available in the press release section of the DVD Technology's 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.

Timing and results of interactions with regulatory agencies, our forecast of our cash runway and the ability of our products are 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 could differ significantly from those suggested by these statements.

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 a M F 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 todays call are Daniel Zhang Chief Executive Officer of DVD, Sebastian Robotize, Chief Financial Officer, and Cyrus marketing Chief Medical Officer.

I'll now pass the call over to Daniel Daniel.

And thank you and excuse me. Thank you all for joining us on this call today.

So an update on the tests.

Phase III pivotal trial, a bias in peanut with the modified patch in children and children, aged four to seven with a confirmed peanut allergy.

On September 21st we announced that <unk> received a partial clinical hold from the FCA specific to detect it.

It does not affect any other ongoing studies with bias and peanuts.

In the partial clinical hold letter the FDA specified changes to element so there'd be test protocol with the intent for the trial to support a.

Future BLA submission.

The letter indicates the FDA careful attention to the Bts protocol.

Believe it is a constructive whether that reflects not undermine the productive nature of our exchanges with the FDA.

We appreciate the FDA think this matter before any subjects are enrolled in VITAS.

We'd much rather address the agency's additional feedback at this stage.

Actually if any protocol changes yield data Dfc will find more valuable when you.

<unk> a future BLA submission.

Furthermore, our recent exchanges with the agency focus on addressing the partial clinical hold letter and have occurred in a timely manner.

Now our top priority is to resolve.

Partial clinical hold and resume initiation.

Yes.

We understand what the FDA is asking and satisfied with the progress we've made in the six weeks since receiving the letter.

And that's one of them who received the partial clinical hold letter we had started submitting the protocol to study sites for subsequent approval by their institutional review boards.

When we received the letter we rescinded any submitted protocols and pause that process.

However, we are continuing internal preparations will be test and are conducting certain site assessment and startup activity to support a prompt study launch once the partial clinical hold is lifted.

While as of today it is premature to assess the impact of the partial clinical hold letter.

On other previously announced.

Milestones, we do know we will not begin screening subjects by year end.

We will communicate additional update publicly as appropriate.

<unk>.

Once the partial clinical hold has been lifted.

When that happens we plan to host a conference call announcing.

The.

Yes.

Okay.

Following that announcement with the goal of providing clarity on any changes to the Vps protocol.

And timeline.

Let me now move on to a brief update of the financial results for the nine months ending on September 32022.

As of September 30th 2022, cash and cash equivalents were $212.7 million.

Net cash used in operating activities for the nine months was $31 8 million, which is a decrease.

35% from the same period of 2021 and reflects our continued implementation of budget discipline measures.

Our cash runway guidance remains unchanged from our previous guidance.

We continue to maximize the efficiency of our spend and remain highly disciplined in.

In our cash management.

Now looking ahead to the remainder of 2022.

We will continue to be updated as appropriate on this this partial clinical hold.

We also look forward to attending the upcoming <unk>.

American College of allergy asthma, and immunology annual scientific meeting in Louisville, Kentucky, Historically as you know <unk> had a strong presence at the college, we look forward to participating again this year.

I want to thank everyone on the phone and the webcast for joining US today I will now ask first and Sebastien to join me for the question and answer.

So operator, you can open the line for questions that would be great.

If anyone has a question you can press zero one on your Touchtone phone. Once again, if you have a question it's zero one on your Touchtone phone.

I am standing by for questions.

And we do have a question from John Waller Ben go ahead John .

Thank you and thanks for taking the questions.

A few from me.

Hi, Danielle.

The critical hold in.

You are having with FDA.

Are you thinking about.

The food challenge as a primary endpoint do you think youre going to need to change or at least maybe a co primary endpoint based on the feedback that.

As I have been having on the trial design.

No. We don't believe so I think the primary endpoint will remain clinical response as defined by the food challenge month 12 versus zero.

That is not a topic of discussion within.

The critical.

And is FDA dialogue.

Certain criteria. They want you guys to hit in terms of infusion or is it they just want it measured.

Hoping you could provide any more color on the adhesion portion of this.

That is at the very core of what we are discussing with the agency right now.

In addition in statistical criterion around adhesion and the.

We're time flip as it is the two topics to the bigger topic of discussion with the agency.

Okay.

Can you give an update on how youre thinking about moving forward with a one to three year old population after the successful epitope trial.

Yes.

It remains something we wish to discuss with the agency.

Those who book and discuss it with them, but at this point in time.

Our efforts are focused.

On the clinical hold first and foremost.

And one last for me if I may what do we take a look at the R&D spend.

Can you tell us what portion of that was attributed to ramp up for <unk> and how we should think about kind of the spend going forward with the clinical hold in place.

I'll turn to Sebastien answer that question as domestic detail I don't have right now.

So to that how much of our clinical and euro after the spin in the first nine months ago, asking about Jonathan because you're correct.

Yes, so actually we have.

Have you there.

Sebastian.

Your line is open.

But we'll look to pursue best in either.

What I can.

I'll reiterate.

You hit a rating.

Cash guidance that we gave.

With.

Our last quarterly result, so although there's obviously a setback initiation, we're attentive to how we're spending our money.

So as I said, you can translate that to.

We see no need to revise our guidance at this point in time.

Brian amongst guidance our guidance at this point.

Thanks for taking the questions, we're looking towards the update hopefully soon.

Thanks, so much Jonathan Likewise.

And our next question comes from Clement vast shakes go ahead climate.

Good morning.

Bob Hombach.

One question about your previous press release.

Could you. Please provide more color about the comments does the FDA regarding the method of categorization that.

It is about the constitution of the group of childhood according to the active dose.

It is linked to the analyses of this debt, which is a concern post trade.

So good question I'll, let ferrous.

The answer but the fact is it's a caveat the rising.

The adverse events.

The book is they want to use for analysis has nothing to do with.

With the primary endpoint of the assessment of efficacy.

Is that correct.

Yes, that's correct, it's basically just.

Accounting rules related to what Daniel mentioned.

Okay.

Brian .

I'm, sorry can you repeat that.

We ran some so it properly.

So it is about the constitution of the group of children that the categorization data.

Yes.

Yeah.

<unk> of children experiencing specific adverse events, how do we get to be categorized.

Alright, okay. Thanks.

Okay, Alright, thank you very much.

Thank you.

Our next question comes from Jacob <unk> from campaign go Hey, Jacob.

Yes.

And thanks for taking my question.

I'm just curious if you can elaborate on the progress has been made so far on the whole issue and maybe just tell us what issues have been resolved and what issues remain to be resolved.

Yes at this point in time.

Had good exchanges with the FDA to progress our understanding and theirs. So at this point in time, we don't wish to provide more details on those interactions if as I said they've been productive.

Once the hold is lifted our plan is to be quite fulsome in describing the outcome with the exchanges and obviously any changes to the protocol.

Why the impact on timeline, if any until then.

Anything we say is a death inconclusive.

We have not finalized yet they are lifting the clinical hold.

And could be at a worsening counterproductive to what we believe it's been a very productive relationship with the FDA in addressing the clinical hold.

That will be okay with that.

Okay.

Okay. Thanks.

And our next question comes from Matthew Coffeyville costs Coffield from HC Wainwright go ahead Matthew.

Great. Thank you guys for taking our question and I appreciate the update.

Just one quick clarification and then one follow up question. So.

One of the previous clarifications the hold itself Youre, saying is about the adverse events being categorized there is no relationship whatsoever to attach correct. It's all about just the categorization of the adverse events.

That was one of the four combos that commented about categorization of the adverse events.

Nothing specific it is specific to the analysis of the study with the past.

Got it if that answers your question.

Yeah, No. That's helpful. And then just one last question if I could.

Any thoughts on the quick turnaround of the clinical hold taking place September 20 <unk> following.

The trial initiation that had just taken place. The first week of September was something missed or was there some sort of miscommunication somehow with the agency is that sort of uncommon for that to happen. So quickly after trial initiation just curious on any thoughts there.

Yes.

I'll share with you our thoughts, yes, we were surprised by the clinical hold.

Unless there is a safety issue to patients easily the agency would have a discussion with the company that was not the case here thats. Okay. Given the fact that the whole did come at a time before we start enrolling patients. So the ability to modify the protocol if need be.

Is not terribly costly when comes to do anything to get the program here.

And we would rather discuss issues that matter to the agency when it comes giving them. The most helpful data evaluating the products that these discussions now before we initiate the trial then afterwards as part of the review process here. So, although we were surprised and it's not common the fact is that.

It's something we think he is going to help us.

And which the program.

When it comes out in the agency assessments.

Very helpful. Thank you for that.

Thank you.

Our next question comes from our Sin <unk> go ahead.

Hello, gentlemen, thank you for taking my question three questions if I may.

Please ask your question.

Hello.

So we can yes, hello, okay, okay, Okay, sorry, okay.

Could you give us more color on the meaning of the categorization of adverse event I'm not sure it will on the thumb.

What.

What what the meaning of this on what is the link between.

These.

How your number of patient data for your <unk>. This is the first question second one is when do you think that the FDA would give you.

Back on the old pharmacist can equal to you on the last one is there any impact on your cash burn of the institution function. It.

Three good questions I'll have Paris answer the first and second one and I'll take the test.

So any more detail.

Sure you can share service on the.

Adverse event categorization.

Yes, it's simply how the FDA wanted us to bucket.

Arent adverse events that occurred.

It's really as simple as that we're not changing how we collect them or the types of events just wanted them categorized in one bucket, we felt it should be in a different bucket and so it was really as simple as that I don't know if that answers your question sufficiently but that was it and there was no.

Between that and the number of subjects.

Two different issues.

Okay, but if I may.

On the well.

Asks you to increase the number of patients falling off for your phase III.

They did but it is not related to okay.

Yes, it was.

This was not the power up to be able to better identify address eventually trials are not powered on safety the power and efficacy.

And the agency wanted.

More patients in this case exit enriched safety database not to power up the efficacy but.

That being said, we had cash obviously for no more than 30 months.

Three years.

That's a long time you have a good treasury at $213 million is the levers we can pull obviously to best preserve cash. So at this point in time. Despite the fact that it will have an impact obviously on our cash burn it does not change the guidance we had given.

At the end of.

Q2.

Okay. Thank you.

Thank you.

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

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