Half Year 2023 DBV Technologies SA Earnings Call
Speaker 1: Good afternoon and welcome to the DBB technology second quarter financial results conference call. My name is Deis Navi and I am the operator for this call.
Speaker 1: At this time, all participants are in a listen-only mode. Should you need assistance, please signal for a conference specialist by pressing star and zero. 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. And now, I'd like to turn it over to Katie Matthews, Head of Investor Relations. Katie, please go ahead.
Speaker 1: Thank you. This afternoon, DBV Technologies issued a press release that outlined our financial results for the three and six months ended June 30th, 2023.
Speaker 1: This press release is available in the Press Releases section of the DBV Technologies website.
Speaker 2: 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.
Speaker 2: 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.
Speaker 2: 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.
Speaker 2: Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements.
Speaker 2: 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.
Speaker 2: Accepted or 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.
Speaker 2: Joining me on the call today are Daniel Taffe, Chief Executive Officer of DBV, Dr. Faris Mohadin, Chief Medical Officer and Sebastian Robitaille, Chief Financial Officer. I will now pass the call over to Daniel. Daniel.
Speaker 3: Katie, thank you, and thank you all for joining us on this call today.
Speaker 3: The purpose of this call today is twofold. One, to provide a business update on our two Biaskin peanut programs, including feedback we received recently from the FDA through a Type C meeting.
Speaker 3: on our two pending supplemental safety studies, one in toddlers, one in children, and secondly, to review DBV financial highlights for the first time in 2023.
Speaker 3: Now let me summarize what I think has been well established regarding our two-by-a-skin peanut development programs before turning the call over to Faris for an update on recent FDA exchanges and next steps in our clinical and regulatory work.
Speaker 3: As you know, DBV is advancing in parallel to chemical programs for bioskin peanuts, bioskin peanut in toddlers, age one to three, and bioskin peanut in children, age four to seven.
Speaker 3: It's important to recognize that Viaskin, Peanut, and 1- to 3-year-olds and Viaskin, Peanut, and 4- to 7-year-olds are separate product candidates with independent clinical and regulatory paths that we believe will ultimately support two distinct BLAs.
Speaker 3: With that being said, as a reminder, let me pass the call on to Faris. We'll share with you more details. features are crawling through the data center form
Speaker 4: Thanks, Danielle.
Speaker 5: Let's start on slide number three with the pathway for toddlers.
Speaker 5: Just to remind you, the Viaskin Peanut Program in toddlers, ages 1 to 3, uses the original square Viaskin Peanut Patch.
Speaker 5: Efficacy in this age group was fully supported by our Phase III study known as Epitope.
Speaker 5: which was completed in June 2022.
Speaker 5: Recapping those results, Fiske and Peanut demonstrated a statistically significant treatment effect with a p-value of less than 0.001.
Speaker 5: with a 67% of subjects
Speaker 5: in the Vascin peanut arm needing the treatment responder criteria after 12 months.
Speaker 5: That's double compared to 33.5% of subjects in the placebo arm.
Speaker 5: The predefined endpoint was achieved with the lower bound of the 95% confidence interval being 22.4% which was well above the prespecified 15% mark.
Speaker 5: We were, of course, delighted that the results from Epitope were published in the New England Journal of Medicine in May.
Speaker 5: This past April , we received pre-BLA written responses from the FDA regarding the next steps for the VioSkin® Peanut Toilet Program.
Speaker 5: As we have previously announced, the agency confirmed that our Phase III epitope study met the pre-specified criteria for success for the primary endpoint.
Speaker 5: and therefore did not request an additional efficacy study.
Speaker 5: The FDA did ask that we conduct a supplemental safety study using the original square bioscale peanut patch. However, with the arms fat, the
Speaker 5: to support and complement the efficacy and safety results collected from Epitope.
Speaker 5: This study is intended to bring the safety database in this age group to approximately 600 total subjects on active treatment.
Speaker 5: 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.
Speaker 5: Let me add a little more detail around that.
Speaker 5: The FDA has not raised any specific safety concerns with respect to the VioSkin Peanut Development Program, which includes toddlers and children.
Speaker 5: Thus, we are not looking for or being asked to assess any specific safety signal in particular.
Speaker 5: The FDA has been consistent in their communications with us, dating back to the original BLA in 2019.
Speaker 5: and one can expose your numbers on active treatment to be approximately 600 subjects in total.
Speaker 5: Let's move now to slide number four and the four to seven year old indication in children..
Speaker 5: which is evaluating by skin peanut using the modified circular patch.
Speaker 5: Efficacy will be supported by our PIVENEL Phase III study, the test.
Speaker 5: which was modeled on PPETES, our phase three study in 4 to 11 year olds.
Speaker 5: We initiated enrollment in the test in March and we are making good progress.
Speaker 5: As with toddlers, we also plan to initiate a supplemental safety study in approximately 270 additional peanut allergic children ages 4 to 7 years.
Speaker 5: 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.
Speaker 5: Recall that in December of last year, the FDA agreed that the supplemental study in four to seven year olds would be six months of treatment duration.
Speaker 5: Now let's discuss the progress that we have made with our Vaskin peanut supplemental safety studies, following receipt of type C meeting, rich in responses from the FDA.
Speaker 5: The meeting had two main objectives, one, to discuss key study design elements and two, to agree that a six month study would be adequate and toddlers.
Speaker 5: Let me summarize where we are.
Speaker 5: Both safety studies, toddlers and children will be six months in duration.
Speaker 5: They will be double-blind, placebo-controlled studies.
Speaker 5: No food challenges will be required for participation for either study.
Speaker 5: As I just mentioned, the four to seven-year-old children's safety study will include about 270 subjects.
Speaker 5: The toddler safety study will include about 400 subjects in total.
Speaker 5: Both studies will have three to one randomization of active tutusivo.
Speaker 5: Both supplemental safety studies will also generate patch adhesion data in the same manner previously agreed to with the FDA for the VATES phase 3 study.
Speaker 5: Now that we have received this feedback, we will finalize the protocols and submit them to the FDA for their formal 90-day review.
Speaker 5: Biscuits is a novel, complex product for which there is no analog.
Speaker 5: and we believe that taking a best practice approach with the formal FDA review process serves us and the FDA very well.
Speaker 5: As they said, a picture is worth a thousand words.
Speaker 5: So here's a picture of the two patches.
Speaker 5: Both have the same foam ring and 215 microgram dose of peanut protein.
Speaker 5: The only difference is the shape and the size of the overlay.
The safety studies will be named comfort toddlers in one to three year olds and comfort children in four to seven year olds.
Comfort stands for characterization of the optimal management.
of food allergy, release and treatment. Thanks forogne Ahora,
At this point, I'll turn the call back over to Danielle to review the financial results.
Daniel. Beautiful.
Thank you, Ferris. Now, let's briefly review financial highlights of the first half of 2023. We move to slide number eight.
Cash cash movements were $174 million US as of June 30th, compared to a position of $209.2 million of December 31st.
The net decrease of $35.2 million.
A cash use for operation is six months ended on June 30, 2023, increased by 34.7 million compared to the six months ended June 30, 2022. Now in 2022, the company received 24.8 million euros during the six months ending June 30, 2022.
for reimbursement of 2019-20 and 21 French research tax credits.
We raised $7.8 million, proceed from the issuance and sale of new ordinary shares in the form of American Depository Shares ADS, which took place on June 16th of 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 spend.
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 1,400 subjects enrolled in VIASP and PINUS Phase III studies, which is the bulk of our focus and our cash use. What?
So let me summarize, if I was covered quite a bit of information today. So I'm your recap.
Our Sony 7-Erol F-C-C-30 V-TES.
Opened with first subject screen in March of this year and we are pleased.
with the ongoing progress of that trial.
We are also actively finalizing the two supplements, comfort safety study protocols in toddlers and children. We expect to initiate the studies once we have finalized the review of the protocols in parallel. We are diligently working on appropriate study startup activities.
For both supplement safety studies, and there's 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 toddler safety study will be an important step towards filing a BLA.
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 who are joining us today. I will ask Sarah.
and our Chief Financial Officer, Cipassia, to join me for a Q&A. Operator, let's open the line for questions, please.
We will now begin the question and answer session to ask a question you may press star then one on your touch tone phone. If you're using the speaker phone, please pick up your hands up before pressing the keys.
If at any time your question has been addressed and would like to withdraw your question, please press star, then too.
At this time, they will pause momentarily to assemble a roster.
The first question comes from John Walliden with JMP Securities. Please go ahead.
Hey, good afternoon and thanks for taking the questions.
Good day, sir.
Good talking to you now. A 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 programs?
It's real and one front, I'll let Sarah sense with a question since he's doing all the hard work. Sarah's.
Yeah, hey John , hi, Ben.
So protocol details, it's just the usual sort of last bit of details you wanna get alignment on, some inclusion, exclusion type things. The main things that we mentioned that we were really happy about were the six month duration. Remember, we weren't sure if that could have been a 12 month.
and then the size of the trial.
and then the size of the trial.
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 said.
And then we'll submit it back to them.
I'm not sure if that really answers your question, but as I said, we're working hard to finalize it and then we'll get it out the door.
Okay, and can you give an update on the VITS enrollment? You guys have previously said you expect the screen to last 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 a comfort children now until my teeth is done screening. If that's still the expectation for kind of staggering those studies.
Yeah, it isn't me take that one. If you test 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's top plan results first half of 2025. That's unchanged, things are progressing as planned.
As you know, safety trials are a view that we've proved in the FSC trials in this space. Being a six-month trial, our plan is still
to initiate comfort in children towards the end of enrollment of the ZTEST trial. That's to not compete with ourselves. People, they also go to the same sites, which now many investigators know as well and know the product well.
And so that remains very much the plan here. I hope it answers your question.
No important question, it does not. We expect the study would be six or 12 months. In duration, turns out to be six, consistent with real lives, which was a safety toll accompanying four, 11-year-olds back in 2019. And the six months come for children's rel. 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 relevant execution.
and this is that we have from the FDA changes nothing to what was hard clinical trial plans. Great. Thank you again for taking the questions and regrets. Thank you. Thank you. If you have a question, please press star then one to be joined in this queue.
Daniel, looks like there are no more questions. Do you have any closing remarks?
Nothing but a big thank you to you, Vishnavi, and 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.
The conference is now concluded. Thank you for joining today's presentation. We all now disconnect.