DBV Technologies Q3 2023 Earnings Call Transcript

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October 31, 2023

There are 5 speakers on the call.

Operator

To the DBV Third Quarter Financial Results and Business and Regulatory Update Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations.

Operator

Please go ahead.

Speaker 1

Thank you. This afternoon, BBV Technologies issued a press release that outlines our financial results for the 9 months ended September 30, 2023. This press release is available in the Press Releases section of the BBV Technologies Web 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 plan. The design of our anticipated clinical trials, 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, These forward looking statements are based on assumptions that are subject to 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 AMS 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.

Speaker 1

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 and Doctor. Faris Mohardin, EPV's Chief Medical Officer, I will now pass the call over to Daniel. Daniel?

Speaker 2

Katie, thank you and thank you all for joining us on this call today. The purpose of today's call is to first provide a business update On our 2 Via Skin Peanut Programs, including the receipt of DBV's requested feedback from the FDA regarding Remaining protocol design elements for our 2 pending supplemental safety studies, which as you know, our name Comfort Toddlers and Comfort Children And secondly, to review with you DBV's financial results for the Q3 of 2023. Let me start by summarizing what has already been established regarding our 2 Bison Peanut programs and developments Before turning over to Faris for an update on the requested feedback we have received from the FDA and thus the next steps in our clinical and regulatory work. As you may recall, DBV is advancing in parallel 2 clinical programs for Via Skin Peanut. Via Skin Peanut in toddlers, children aged 1 to 3 and Via Skin Peanut in children Age 4 to 7.

Speaker 2

And it's important to recognize that Via Skin PNET in 1 to 3 year olds and Via Skin PNET in 4 to 7 year olds are separate Product candidates with independent clinical and regulatory path that we believe will ultimately support 2 distinct BLAs. Now, let me pass it over to Farris to share with you more details.

Speaker 3

Thank you, Danielle. Let's start with a brief recap of Vioskin Peanut Program in toddlers ages 1 to 3, which you will recall uses the original Square Biosk and Peanut patch. We already completed Our pre BLA meeting for toddlers in April of this year. As we previously announced, the agency confirmed That our Phase 3 epitope study met the pre specified criteria for success for the primary endpoint and therefore Did not request an additional efficacy study. The FDA did ask for a supplemental Safety study with the original square patch to increase the total number of subjects on active treatment to approximately 600 The 47 year old indication will also have a supplemental safety study to increase the number of subjects on treatment with the modified Circular patch approximately 600 subjects when combined with the active subjects in the test, the ongoing Phase 3 efficacy and safety study.

Speaker 3

So, we believe there is nice symmetry to the 2 BLA programs. The 1 to 3 year old indication has a completed efficacy and safety study in epitope and a planned We believe that this will constitute the pivotal studies needed for a BLA submission. Similarly, the 4 to 7 year old indication will have the test for efficacy and safety We've discussed the key design elements of both But just to remind you, both studies will be 6 months in duration, Double blind, placebo controlled, 321 randomization, active to placebo and both will generate adhesion data. Comfort toddlers will include 400 subjects and comfort children will be 270 subjects in total. These numbers have not changed.

Speaker 3

Okay. So that brings us to today. After receiving the Type C meeting feedback on the safety studies in July, we requested clarification from the FDA. There were a few remaining protocol design elements relevant to both safety studies, As well as one of the inclusion criteria, just for comfort toddler, that we felt needed additional clarity. I'm pleased to report that we have received written feedback from the FDA clarifying those remaining protocol design elements.

Speaker 3

The protocols for both supplemental safety studies will have the same language guiding how the product should be used, Such as each DDV-seven twelve-two fifteen microgram epicutaneous system is intended We believe that this language is more concise And simpler and harmonizing the language in both safety studies makes a lot of sense. Further to this approach, both supplemental safety studies will seek to enroll subjects that are as closely aligned with their respective Phase III efficacy studies as is feasible. For comfort toddlers, This means using the same eligibility criteria as in the epitope study. In epitope, the main inclusion criteria centered around a documented history of peanut allergy Confirmed by immunologic markers, IgE and skin prick testing and A double blind placebo controlled food challenge. We previously believed that no food challenge would be required for comfort toddlers.

Speaker 3

But in exchanges with the FDA, we chose these inclusion criteria options as the best way to ensure That we could recruit a study population that would be as similar to Epitope as possible. While there is a significant body immunological literature in older peanut allergic children. The same is just not true in the toddler range. Because of this, we felt that reliance on immunological parameters alone for the main inclusion criteria However, for Comfort Children, we will use a history of peanut allergy and immunologic parameters for the inclusion criteria. The medical literature supports this approach as does our experience in the completed 4 to 11 year old safety study REALIZE, which served as a supplemental safety study for petites.

Speaker 3

With this approach, we are confident That we can enroll a study population that will be similar to that of the test. There will not be a need Since epitope was a successful study meeting the pre specified criteria for success for the primary endpoint And we have received regulatory guidance from FDA. Comfort toddlers is our highest priority to get started as quickly as possible. Now that we have received clarification, we can submit the safety protocol to the FDA expeditiously and anticipate enrollment to begin in the Q1 of 2024. In parallel, the comfort children protocol Since it is a smaller study relative to Comfort Toddlers And we don't wish to compete with the test recruitment at this time.

Speaker 3

We plan to initiate enrollment in Comfort Children after Comfort Toddlers. We are continuing to work diligently on appropriate study start up activities for both COMFORT studies, while in parallel continuing to advance the test, our Phase 3 study in 4 to 7 year olds. To summarize, we are very pleased with the engagement and clarity of the feedback received from the FDA. We feel that harmonizing the approach to how the product should be used is even simpler and more concise than what previously existed. We are confident we can enroll subjects in our supplemental safety studies that will align nicely with the respective efficacy studies, And we remain confident that this work will support BLAs in both age groups and potentially bring a new treatment option to clinicians and families.

Speaker 3

At this point, I'll turn the call back over to Daniel to review the financial results. Daniel?

Speaker 2

Thank you, Farris. And now let's briefly review the financial highlights for Q3 2023. Our cash and cash equivalents as of September 30 are $149,100,000 compared to Sorry, dollars 209,200,000 as of December 31, 2022, a net decrease of $60,100,000 Mainly due to the following, dollars 66,000,000 of cash was used in operating activities, mainly driven by clinical work And initiation of the TTEST trial where the first patient was screened in March of this year, and then $7,000,000 of net Proceeds from the issuance and sale of new ordinary shares in the form of ADSs, which took place on June 16, 2023, pursuant to the company's at the market program, which was established in May of 2022. You can see we continue To maximize efficiency of our spend, we remain highly committed and disciplined in our cash management. We have a lot of clinical work to do by next year.

Speaker 2

We anticipate we'll have about 1400 patients or subjects who should stay enrolled in VASKIN PEANUTS Phase 3 We have covered a lot today and if you allow me to recap, Paracis' team is working diligently Implement the feedback we requested from the FDA into the Comfort Safety Study protocols for submission to the agency. We expect to submit the finalized Comfort Toddlers protocol in the next few weeks, anticipate initiating the Comfort Toddlers study In the Q1 of 2024, we believe that the successful completion of the supplemental Comfort Towler safety study will be an important step Towards filing a BLA seeking, marking approval in the U. S. Of this potential novel therapy for peanut allergenic After the start of Comfort Toddlers and in close alignment with Vitesse recruitments, we are continuing to advance Vitesse, Successful completion of which will be an important step towards filing a separate BLA, seeking marketing approval in the U. S.

Speaker 2

I want to thank everyone on the phone And on the webcast for joining us today, I will now ask Faris to join me for Q and A. Operator, if you could open the line, please.

Operator

We will now begin the question and answer session. Our first question will come from Rajan Sharma with Goldman Sachs. You may now go ahead.

Speaker 4

Hi, and thanks for taking my questions. So firstly, just on Time lines and I was just wondering what impact does the need for food challenging comfort toddlers have on your anticipated time line. So I'm conscious that you mentioned that the duration of the trial itself is not changing, but just wondering if you expect the need for food challenge to impact Enrollment timelines or kind of the set which you could enroll that trial? And then I just have a follow-up as well, please.

Speaker 2

Sure. Frank, do you want to take that one?

Speaker 3

Sure. So, as I said, Rajan, we anticipate first patient to be enrolled in Q1 of 2024, we expect that the food challenge could add some time to the recruitment period, But we know our sites well and they know how to do food challenges well. And we believe that there's More understanding of our product and this probably is generated from the New England Journal of Medicine publication. So It's a really good time. And so once the study is initiated, we'll have a better understanding of the timeline And we'll come back with more details.

Speaker 3

But right now, we're not going to talk about the back end until we get the study up and running and rolling and see how things are going. But we're confident that we can get this done.

Speaker 4

Okay, perfect. Thank you. And then the follow-up was just around costs. I'm just wondering if the food change requirement Impacts the potential cost of the trial and whether you're comfortable that you kind of have sufficient runway to fund through to completion of all of the required trials?

Speaker 2

So the addition of the food challenge will not add significantly to the cost of the trial. So that's not a factor here. And as we've guided Rajan, we have sufficient cash to go into 2025. That's not enough. We need to complete all of those trials.

Speaker 2

We'll be looking at raising capital at one point in time, but in no rush to do so. And as Sarah said, job one for us right now is get those studies up and running, Which we can do rather expeditiously. So this

Speaker 3

is where we stand when

Speaker 2

it comes to financial position. We're in a good position to be able to do everything that's right by the business And look at access to capital in due time, we're in no rush to do so.

Speaker 4

Okay, perfect. Thank you very much.

Speaker 2

Thanks, Sudan. Good to hear from you from London, by the way. Thanks for calling.

Operator

This concludes our question and answer session. I would like to turn the conference back over to Mr. Daniel Tasse for any closing remarks.

Speaker 2

I just want to thank everybody again for joining us today. Important developments for us. And as always, we're always available for continued conversations. Thank you. And I wish also all those of you with the little ones a happy tour of the meeting.

Speaker 2

Have a nice evening.

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Key Takeaways

  • DBV is advancing two distinct BLA programs for ViaSkin Peanut in toddlers (1–3 years) and children (4–7 years), each with its own independent clinical and regulatory path.
  • Following a successful Phase 3 epitope study in toddlers that met prespecified endpoints, the FDA only requested supplemental safety studies rather than additional efficacy trials.
  • DBV has received written FDA feedback clarifying protocol design and harmonizing inclusion criteria for both Comfort Toddlers and Comfort Children safety studies to align with prior Phase 3 designs.
  • The Comfort Toddlers protocol will be submitted in the coming weeks with enrollment expected to begin in Q1 2024, followed by the Comfort Children study once toddler recruitment is underway.
  • As of September 30, 2023, DBV held $149 million in cash, providing runway into 2025; management remains disciplined on spending and plans any future capital raise in due course.
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Earnings Conference Call
DBV Technologies Q3 2023
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