DBV Technologies Q2 2023 Earnings Call Transcript

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July 31, 2023

There are 4 speakers on the call.

Operator

Good afternoon, and welcome to the DBV Technology Second Quarter Financial Results Conference Call. My name is Vaishnavi, and I am the operator for this call. At this time, all participants are in a listen only mode. Following the formal remarks, we will open up the call for your questions. Please be advised that this call is being recorded at the company's request.

Operator

And now, I'd like to turn it over to Katie Matthews, Head of Investor Relations. Katie, Please go ahead. Thank you. This afternoon, DBV Technologies issued a press release that outlined our financial results for the 3 6 months ended June 30, 2023. This press release is available in the Press Releases section of the DBV Technologies website.

Operator

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, 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 will reflect events or circumstances that occur after this call.

Operator

Joining me on the call today are Daniel Sassay, Chief Executive Officer of DBV Doctor. Faris Mohdine, Chief Medical Officer and Sebastien Robitaille, Chief Financial Officer. I will now pass the call over to Daniel. Daniel?

Speaker 1

KB, thank you, and thank you all for joining us on this call today. The purpose of this call today is twofold. 1, To provide a business update on our 2 VIA Skin Peanut programs, including feedback we received recently from the FDA through a Type C meeting On our 2 pending supplemental safety studies, 1 in toddlers, 1 in children and secondly, to review DBV financial highlights for the first half of twenty twenty three. Now let me summarize what I think has been well established regarding our 2 Viaskin peanut development programs. Before turning the call over to Faris for an update on recent updates changes and next steps in our clinical and regulatory work.

Speaker 1

As you know, DBV is advancing in parallel to Clinical programs for Viascan Peanut, Viascan Peanut in toddlers, age 1 to 3 and Viascan Peanut in children, Age 4 to 7. It's important to recognize that Viascan peanut in 1 to 3 year olds and Viascan peanut 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. With that being said, as a reminder, let me pass the call on to Farris, who will share with you More details. Farris?

Speaker 2

Thanks, Danielle. Let's start on slide number 3 with the pathway for toddlers. Just to remind you, the BioSkin Peanut program in toddlers ages 1 to 3 uses the original Square, BioSkin Peanut Patch. Efficacy in this age group was fully supported by our Phase 3 study known as Epitope, which was completed in June 2022. Recapping those results, BioScantina demonstrated with a 67% of subjects in the Baskin peanut arm meeting the treatment responder criteria after 12 months.

Speaker 2

That's double compared to 33.5 percent of subjects in the placebo arm. The predefined endpoint was achieved with the lower bound of the 95% confidence interval being 22.4%, which was well above the pre specified 15% mark. We were of course delighted that the results from Epitope were published in the New England Journal of Medicine in Med. The publication also featured an accompanying editorial entitled Good News for Toddlers with Food Allergies. This past April, we received Pre BLA written responses from the FDA regarding the next steps for the Vioscan peanut toddler program.

Speaker 2

As we have previously announced, the agency confirmed that our Phase 3 epitope study met the pre specified criteria for success for the primary endpoints and therefore did not request an additional efficacy study. The FDA did ask that we conduct a supplemental safety study using the original square BioSkin Peanut Patch to support and complement the efficacy and safety results collected from Epitope. This study is intended to bring the safety database This age group to approximately 600 total subjects on active treatment, which is consistent with FDA's position in support of the company's dossier in 4 to 7 year olds as previously announced in December 2022. Let me add a little more detail around that. The FDA has not raised any specific Safety concerns with respect to the BioSkin Peanut Development Program, which includes toddlers and children.

Speaker 2

Thus, we are not looking for or being asked to assess any specific safety signal in particular. The FDA has been consistent in their communications with us dating back to the original BLA in 2019. And wanting exposure numbers on active treatment to be approximately 600 subjects in total. Let's move now to slide number 4 and the 4 to 7 year old indication in children, which is evaluating Efficacy will be supported by our pivotal Phase 3 study VITES, which was modeled on PIPPEATS, our Phase 3 study in 4 to 11 year olds. We initiated enrollment in VITAS in March and we are making good progress.

Speaker 2

As with toddlers, we also plan to initiate a supplemental safety study in approximately 2 70 additional peanut allergic children ages 4 to 7 years. When added to the safety data generated by the test, The supplemental safety study in children will bring our safety database to approximately 600 children on active therapy in this age group. Recall that in December of last year, the FDA agreed that the supplemental study in 4 to 7 year olds would be 6 months of treatment duration. Now let's discuss the progress that we have made with Our Biogen peanut supplemental safety studies following receipt of Type C meeting written responses from the FDA. The meeting had 2 main objectives: 1, to discuss key study design elements and 2, to agree that a 6 month study would be adequate in toddlers.

Speaker 2

Let me summarize where we are. Both safety studies, toddlers and children, will be 6 months in duration. They will be double blind, placebo controlled studies. No food challenges will be required for participation for either study. As I just mentioned, the 4 to 7 year old children safety study will include about 2 70 subjects.

Speaker 2

The toddler safety study will include about 400 subjects in total. Both studies will have 3:one randomization of active to placebo. Both supplemental safety studies will also generate patch adhesion data in the same manner previously agreed to with the FDA for the VITES Phase 3 study. Now that we have received this feedback, we will finalize the protocols and submit them to the FDA for their formal 90 day review. Bios Concina is a novel complex product for which there is no analog And we believe that taking a best practice approach with the formal FDA review process serves us and the FDA very well.

Speaker 2

As they say, a picture is worth a 1,000 words. So here is a picture of the 2 patches. Both have the same foam ring and 2 50 microgram dose of peanut protein. The only difference is the shape and the size of the overlay. The safety studies will be named comfort toddlers in 1 to 3 year olds and Comfort Children in 4 to 7 year olds.

Speaker 2

Comfort stands for characterization of the optimal management of food allergy relief and treatment. At this point, I'll turn the call back over to Daniel to review the financial results. Daniel?

Speaker 1

Thank you, Faris. Now let's briefly review financial highlights for the first half twenty twenty three, if we move to slide number 8. Cash, cash equivalents were $174,000,000 as of June 30 compared to a position of $209,200,000 as of December 31st, so a net decrease of $35,200,000 $46,400,000 of cash were used in operating activities, which being a biotech company was mostly driven by clinical R and D With initiation of GITEX Phase 3 trial being the biggest component here. Cash used for operations is 6 months ended on June 30, 2023 increased by $34,700,000 compared to the 6 months ended June 30, 2022. Now in 2022, the company received €24,800,000 during the 6 months ending June 30, 2022 for reimbursement of 2019, 2020 2021 French research tax credits.

Speaker 1

We raised $7,800,000 proceeds from the issuance and sale of new ordinary shares in the form of American Depository Shares, ADSs, which took place on June 16, 2023 pursuant to our at The market ATM program, which was established in May of 2022. In closing, we continue to maximize the efficiency of our And to make sure we are highly disciplined in our cash management, we have a lot of clinical work to do by next year. We anticipate that about 1400 subjects enrolled in Viante Quintina Phase 3 studies, which is the bulk of our focus and our broadcast sheet. So let me summarize, because I would cover quite a bit of information today. So let me recap.

Speaker 1

Our 4 to 7 year old efficacy study, VITAS, opened with 1st subject screened in March of this year and we are pleased with the ongoing progress of that trial. We are also actively finalizing the 2 supplement The protocols in parallel, we are diligently working on appropriate study start up activities for both supplement safety studies And there are things such as site feasibility, site selection contract with many sites that can be done very effectively in parallel. We believe That the successful completion of the supplemental comfort toddlers safety study will be an important step towards filing ABLA seeking marketing approval of this potential novel breakthrough technology for peanut allergic toddlers And their families, I want to thank everyone on the phone and webcast for joining us today. I'll ask Farris and our Chief Financial Officer, Sebastien, to join me for Q and A. Operator, let's open the line for questions please.

Operator

We will now begin the question and answer session. The first question comes from John Wallatin with JMP Securities. Please go ahead.

Speaker 3

Hey, good afternoon and thanks for taking the questions.

Speaker 1

Hey, good afternoon.

Speaker 3

It is on mute. Good talking, Danielle. Couple of questions on the update today. Just wondering what other protocol details Are you trying to get alignment with FDA? And when do you think that that could happen to start the Comfort progress?

Speaker 1

Yes, 3 on one front. I'll let Tarik answer that question since he's doing all the hard work. Tarik?

Speaker 2

Yes. Hey, John. How are you doing? So for protocol details, it's just the usual sort of last bit of details you want to get alignment on Some inclusion and exclusion type things. The main things that we mentioned that we were really happy about were The 6 month duration, remember, we weren't sure if that could have been a 12 month and then the size of the trial.

Speaker 2

So Hopefully that answers the first part. When would we get back to the FDA? Again, we're working to finalize that protocol as Daniel And then we'll submit it back to them. I'm not sure if that really answers your question, but as I We're working hard to finalize it and then we'll get it out the door.

Speaker 3

Okay. And can you give an update on the VITICE Enrollment, you guys have previously said you expect to screen the lab patient first half of next year. Just wondering about the early traction you're getting. And then I believe you also previously said you might wait to start, I guess, Comfort Children now until VITICE is done screening. Is that still the expectation for Kind of staggering those studies?

Speaker 1

Yes, it is. Let me take that one. Yes, VCS is enrolling as expected. We are not changing what was the guidance we've given that we would have last patient in first half of next year top line results first half twenty twenty five. That's unchanged.

Speaker 1

Things are progressing as planned. As you know, safety trials are easier to recruit than F-fifty trials in this space. Being a 6 month trial, our plan is still to initiate comfort in children Towards the end of enrollment of the VITAS trial, that's not compete with ourselves. We will be able to also go to the same sites, which Many investigators know us well and know the product well. And so that remains very much the plan here.

Speaker 1

I hope it answers your question.

Speaker 3

Yes. And then one last for me, if I may. Given the Agreement on the high level details from FDA, does this make any changes to your cash runway guidance to With regards to comfort toddlers?

Speaker 1

It's an important question. It does not. We Expect the study will be 6 or 12 months and duration turns out to be 6 consistent with Realize, which was a safety trial accompanying 4 11 year olds back in 2019 and the 6 month COMFORT children trial. So that was very much part of our financial projections here. So we certainly have more than the financial needs initiate all these trials in parallel and drive them to execution.

Speaker 1

And the feedback we have from the FDA changes nothing to what was our clinical trial plan.

Speaker 3

Great. Thanks again for taking the questions and congrats.

Speaker 1

Yeah. Thank you.

Operator

Daniel, looks like there are no more questions. Do you have any closing remarks?

Speaker 1

Nothing but a big thank you to you, Vishnavi, and to everybody joining the call today. As you know, always available for follow-up discussions if you wish. So thank you so much. Have a great day.

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