Our EPITOPE data shows that half of our subjects had peanut-specific IgE levels at or below 14, but still tested positive for peanut allergy by food challenge. That is they had low IgG levels, but we’re still allergic, whereas the older subjects in the middle and far-right figures on the slide, has much fewer subjects with low IgE that were peanut-allergic. We appreciate that, this adds a bit of complexity to the study and they have a small impact on recruitment. But we believe this will allow us to best replicate the EPITOPE study population for a BLA submission in the future. As we have stated previously, we will initiate COMFORT Toddlers after we receive FDA feedback on the protocol, which was submitted in November last year. The DBV clinical team has been gearing up with our CRO for study initiation.
We believe, we are in a position to initiate the study in a short period of time, pending FDA feedback on the protocol. With that, back to you, Daniel.
Daniel Tassé: Thank you, Pharis. Before turning the call over to Virginie to review the financials, let me cover a corporate update. During the fourth quarter, we further strengthened our leadership team in advance of our two BLA submissions and anticipated commercialization, so that we are best positioned for long-term success. On top of our new CFO, Virginie, who joined us in November, we appointed Dr. Kevin Malobisky, PhD, as our new Chief Operations Officer. Kevin has an extensive track record of more than 35 years in biopharmaceuticals, strategic and operational leadership roles, including roles that span both research, as well as drug development and drug approval. Kevin will be instrumental to a successful BLA submission, and I couldn’t be more thrilled that he has joined our leadership team.
I would like to take the opportunity to formally welcome Kevin to our team, and he’s already making a very positive impact. So, really delighted to have both Virginie and Kevin joining us. Without further ado, we’ll invite Virginie to cover briefly our financial highlights.
Virginie Boucinha: Thank you very much, Daniel. And I will now provide a brief overview of our financials for the year 2023, which I invite you to further review in our press release and filings. There are three highlights, I would like to point out for year 2023. Number one, we closed the year with $141 million in cash. Number two, we dedicated over 90% of the cash we used in operations to progressing Viaskin Peanut’s clinical development and preparing for BLA filing. Number three, our 2023 P&L includes the favorable impact of the termination of our collaboration with Nestlé. As you may be aware, in quarter four of last year 2023, we terminated a collaboration agreement with Nestlé, which was meant to develop and commercialize a diagnostic market for cow’s milk allergy.
This contract was draining resources and attention away from our priority Viaskin Peanut, with neither tangible nor medium-term income. Terminating the contract was a financially sound decision with material positive impact on 23 financials expenses and net loss. One more word on our financials and resources allocation. If you consider our financial statements without the impact of the Nestle collaboration agreement our operating expenses increased by 25% in 2023 to support VP clinical Viaskin Peanut clinical studies, CMC preparation regulatory activities and getting ready from the manufacturing site in view of all of this for the approval and launch [indiscernible] Back over to you Daniel.
Daniel Tassé: Thanks, Virginie. Now before communicate DBV’s upcoming milestones I would be remiss, if I did not take a moment here to appreciate how much the food allergy landscape has changed in the past few years and we believe Viaskin Peanut will serve that community. There’s nothing. We see more clearly from the food allergy community that this therapeutic area desperately need treatment alternatives. The recent FDA approval of Ameluz omalizumab, which was the brand name is all there for the treatment of food allergy and adult is a welcome addition. We see treatment for food allergy requiring a range of options just like others immunological conditions such as asthma, atopic dermatitis or inhaled allergies. And I’m asking you here to imagine the position of a parent with a young child was diagnosed with peanut allergy either pediatricians office or the allergists office [ph] until very recently stopped there.
The only option available to concerned parents and caregivers was avoidance and diligent readiness with epinephrine auto-injector. Today is a different story. And over time we keep on getting different better. Children are now channeled to the allergist office where they and their families can have real conversations as illustrated here about all the conditions there and all the circumstances that surround and the life of that shop in that family. And that was another topic that we picked up in talking with KOLs and experts at quantity. I having a range of treatment options available only fuels that conversation and for the 670,000 children in the US ages one through seven currently living with a daily burn of a peanut allergy. Every patient story in situation is unique, requires a bespoke solution and that’s what’s needed here.
Simply put one size will not fit all. In an ever-evolving market and we want to be very much part of that evolution, Viaskin Peanut will always be a very important product in fact it will be the opinion of most a foundational product as was evident after speaking with hundreds of outages attending [indiscernible] conference. Before I open up the call for questions I would like to take a moment to share our anticipated milestones for 2024 and this is a critical year for DBV. We anticipate initiating the first subject of our COMFORT-II trial the six month supplemental safety trial in support of the BLA. We also anticipate completing enrollment of our ongoing Vitesse Phase 3 efficacy trial in children aged four to seven years of age. And once the test enrollment is close to completion.
We’ll initiate recruitment for our six month comfort children trial in support of that PLA. Recruitment as far as touched on will be carefully time so as not to compete for the same study subjects across two different clinical trials. During the second quarter, we also plan to host an Investor Day and we will share those details as soon as possible. We hope many of you will be able to join us. We also plan to announce the three-year results from our ongoing Phase 3 open-label extension of the October trial earlier on this year. And finally the publication in Science and Medical Affairs [indiscernible] DBV continues to be operating very actively, anticipate publication of additional manuscripts which includes publications of the results of the year to open label extension of EPITOPE, which Pharis showed a few minutes ago and additional invite review with a peer-reviewed scientific journal as well as submitting abstracts of new results for presentation in upcoming conferences and we’ll keep on publishing a lot of data on our technology and its benefits.
