Good day, welcome to the DBV Technologies' full year 2022 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touch tone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Ms. Anne Pollak, DBV Investor Relations. Please go ahead.
Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31st, 2022. This press release is available in the press release section of the DBV 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 our cash runway, and the ability of our product candidates 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 or reflect events or circumstances that occur after this call. Joining me on today's call are Daniel Tassé, Chief Executive Officer of DBV, Sébastien Robitaille, Chief Financial Officer, and Pharis Mohideen, Chief Medical Officer. I will now pass the call over to Daniel. Daniel?
Anne, thank you. Thank you all for joining us on this call this afternoon. In a few moments, Sébastien will walk you through the highlights of the full year 2022 financial results. Before he does that, I'd like to take a few moments to talk about recent clinical updates. Last year, our top priority was to finalize the design and protocol of VITESSE, the phase III pivotal study of the modified Viaskin Peanut patch in children ages 4 to 7 with a confirmed peanut allergy diagnosis. We did that. We are on track to screen our first patient by the end of the Q1 this year. We look forward to providing an update when this event occurs.
Now, in advance of initiating VITESSE, we completed a study called EVOLVE, which was a 12-week caregiver and patient user experience study with the modified Viaskin Peanut patch in 50 peanut allergic children, ages four to 11 years of age. Now, our objective with EVOLVE was pretty straightforward. It was to optimize the eDiary tool that families will use in VITESSE to best capture patch adhesion and patch experience data. I will invite Pharis to speak in more detail about EVOLVE, what we learned from it, as well as also update you all on Viaskin Peanut data that was presented last weekend at the American Academy of Allergy, Asthma & Immunology annual scientific meeting, the meeting that we all know as quad AI. Pharis?
Thanks, Daniel. As Daniel said, EVOLVE was a user experience study designed to provide qualitative data on several study elements that would also be used in the test. A phase III study in four to seven -year-olds. In EVOLVE, we tested the functionality of an electronic patient diary called the eDiary, to collect information on activities of daily living and patch adhesion scores. As we have previously discussed, the test will assess patch adhesion of the modified Viaskin Peanut patch, and we will include a statistical test of adhesion into the test stats analysis plan. EVOLVE verified that the eDiary tool can be used by caregivers to capture the adhesion data in the test that is required to support a potential BLA application. I'm also pleased to report that EVOLVE showed that the updated instructions for use, the IFU, supported correct patch application.
Which we defined as no lifting of the patch edges or detachment directly after application. Furthermore, the majority of parents and caregivers reported a positive ease of use experience with the modified Viaskin Peanut patch. We have always believed in the importance of ease of use in a potential peanut allergy treatment profile, and we continue to believe that the overall product profile of Viaskin Peanut will appeal to peanut allergy families. Let's turn now to the American Academy of Allergy, Asthma and Immunology annual scientific meeting, which took place last weekend in San Antonio. AAAAI is among the most important and widely attended meetings on allergy and immunology each year, and DBV had a strong presence this year, as we do every year.
DBV had two EPITOPE posters at the meeting that summarized the efficacy and safety profile of epicutaneous immunotherapy with Viaskin Peanut in peanut-allergic children aged one to three years with and without certain comorbid atopic conditions. Specifically, we assessed if treatment response or safety of Viaskin Peanut therapy was influenced by either baseline atopic dermatitis or concomitant food allergy. Both of these conditions are common comorbidities in young children with peanut allergies, each having a reported prevalence rate of 60%-70%. The results demonstrated consistency in Viaskin Peanut safety and efficacy across multiple patient groups, those with and without other food allergies and atopic dermatitis. Furthermore, treatment with Viaskin Peanut for one year did not appear to result in a change in atopic dermatitis severity for children ages one to three years old.
We believe that these EPITOPE data analyses further validate the potential benefit of using the Viaskin platform for the treatment of peanut allergy in young children. For those of you who would like to read the posters in detail, they can be found in the scientific publications and presentations section of the DBV website. At this point, I'll turn the call over to Sébastien to review the financial results. Go ahead, Seb.
Thank you, Pharis. Let's briefly review financial highlights for the full year 2022. Cash and cash equivalents were $209.2 million as of December 31, 2022, compared to $77.3 million as of 31, 2021, which is an increase by $131.9 million, mainly due to $194.1 million in financing activities in Q2. Net cash used in operating activities for the full year was $81.8 million, which is a decrease of 24% compared to prior year, reflecting the cost containment measures that have been continuously maintained since their implementation in 2020. Finally, in the last quarter, our treasury position, which is stated in US dollars, benefited from a change in the euro to the US dollar exchange rates.
The company's activities and expenditures in the Q4 were in line with expectations, and we continue to maximize the efficiency of our spend, and we remain highly disciplined in our cash management. I will turn the call back to Daniel Tassé for closing remarks.
Thank you, Sébastien.
That's it.
In closing... Can you hear me? Can you hear me?
Yeah. Yeah.
Yes. Yes, we can hear you.
Okay, cool. Sorry about that. In closing, I'm very pleased with our continued financial discipline and progress across our clinical programs. Looking ahead to the remainder of 2023, we'll continue to keep you updated as appropriate on our VITESSE phase III trial progress in children ages four to seven , as well as our development plans for Viaskin Peanut as a potential treatment for peanut-allergic toddlers ages one to three . I want to thank you all on the phone today on the webcast for joining us. Operator, let's open the line for questions if there are any.
Yes, sir. 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 a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we'll pause momentarily to assemble our roster. The first question will come from Jonathan Wolleben with JMP. Please go ahead.
Hey, Jonathan Wolleben here. Thanks for taking the question. A few on EVOLVE, the eDiary study. Wondering if this was requested by FDA, why four to 11 versus four to seven ? Did you collect any other data, whether, you know, patch adhesion site reactions, anaphylaxis or any safety data, anything else you can learn from the EVOLVE study besides validating the eDiary?
I'll have Pharis give you more details. To be clear, no, this was entirely our decision. This decision was made when we were contemplating doing a new pivotal trial. Given the fact we have a new patch, we also know, John, I think that now adhesion on application is a marker of adhesion, obviously, through the day. That we'll be using eDiary tool to make sure that we capture all the rich data was required to inform the BLA and the label. Our decision was made on our own to sort of... The expression to me was sort of work the yada yads out to make sure that when we rolled out that tool in VITESSE, a pivotal trial, we were very confident it was the right tool for us, which is what this was intended to do.
It was not powered to prove or measure anything. It's something we choose to do or chose to do, again, to make sure that we came into VITESSE confident that we had a good IFU and a good tool to capture the data. Pharis, anything else you wanna add to that?
No, that's correct. I can answer the other questions, if you would like, Daniel.
Yes, please.
Yeah. Okay. Hey, John, how are you doing? As far as the four to 11 versus four to seven. As Daniel Tassé said, this was designed to work the Yayas out prior to starting the test. With the nature of the objective of the study being let's optimize the eDiary and the instructions for use, it didn't matter whether you were four to seven or you were four to 11. As long as you were a peanut allergy subject, we felt that in a caregiver parent of a peanut allergy child, we felt that we could generate the same amount of data. Of course, recruitment for us is always primary in terms of being effective and efficient. We wanted to generate the data in a short period of time.
That's the reason for the four to 11. Nothing more beyond that. In terms of your other questions, yes, we collected safety data, a lot of other things, just as we normally would through any other trial. It performed as it always does, very consistently relative to other studies that we've seen from a safety standpoint. Does that answer your question, John?
Yeah, that's helpful. in the prepared remarks, Daniel, you mentioned that VITESSE will be up and running, this month. Wondering if we could get an update on this, 275 subject safety study you'll also be running, if there's any guidance for when that will be starting. Also if you have any update on your progress in the one to three-year-olds.
Yeah, I'll have Pharis answer the question on one to three year olds. The safety trial accompanies VITESSE where it's meant to enrich the safety database. As you know, the 6-month trial is both a 12-month trial. Enrollment is gonna be faster because 275 obviously is less than 600. Mostly there's no food challenge, which makes enrollment in those trials to be a lot easier. Our plan here is to start the safety trial later on towards the sort of plateauing of enrollment in VITESSE as to not compete with ourselves for patients. We're again planning and confident that we can land the completion of the safety trial at the same time or before the database lock of the VITESSE trial. Does that answer your question?
Yes. That's helpful there. Just wondering about the toddler update, if there is one.
Yeah. Yeah, please, Pharis.
Yeah. as we said in the past, Jonathan, we'll communicate with the FDA this quarter. beyond that, it's probably not prudent to comment in terms of when we would get feedback from them. we'll follow the traditional application processes.
Okay. One more, if I may.
Yeah, sure. Please.
My math might be off, I see a pretty big jump in R&D this quarter. Wondering if there's any one-off expenses in there or how to think about spend moving forward? Thanks.
Seb, do you wanna take the jump in R&D question, which in a startup cost to be tested, we'll see what it is, but any more color you want to provide?
Yes, of course. You're right, Daniel. It's really related to the fact that we initiate some costs on VITESSE. We have some upfront with the CRO. We have I would say a slight ramp-up of our R&D expenses in the last few months.
Thanks for taking my question.
No, it will not carry through. It will not carry through, Jonathan. Again, we reiterate that we have enough cash to complete VITESSE and the safety trial with the cushion. If that changes, obviously we'll communicate that to investors at this point in time. All around good financial discipline. The actual spend as in, you know, activities planned were in Q4 was very much what we had planned when we rolled out the timeframe for both studies.
Got it. Thanks, Daniel Tassé.
Thank you.
Again, if you have a question, please press star then one. This will conclude our question and answer session, as well as our conference call for today. Thank you for attending today's presentation. You may now disconnect.
Thanks, everyone.