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| Statement |
|---|
| We have a well-studied product, with demonstrated efficacy and consistently favorable safety profile |
| 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 |
| This bodes well for the VITESSE study |
| And I'm very proud to say that had an unprecedented attendance |
| In fact, we're told that we broke the record for AAAAI events and the best attended product theater ever |
| Overall, we were extremely pleased, with the results of the 2nd year of treatment from an efficacy point as well as from a safety point |
| We believe these are really impressive results that continue to build upon our extensive and robust Viaskin Peanut clinical dataset |
| This is aligned with a younger four to seven year old age group, where we believe Viaskin Peanut can provide great clinical benefit |
| During the 2nd year of treatment, the safety results in toddlers were entirely consistent with trials in older children, which demonstrated a well-tolerated, predictable safety profile |
| We are very confident or remain very confident this work will support BLAs in both age groups and as we've picked up from dialogues with allergists at quite a AAAAI, we will pick-up when it comes to talking to investigators, we will pick-up in our market research, families want treatment options -- the more treatment options are available, the more dynamic of the market will be and we all benefit from that |
| Terminating the contract was a financially sound decision with material positive impact on 23 financials expenses and net loss |
| So, we're confident this study will enroll at a good pace |
| We're proud of that and we keep on building that database |
| 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 |
| 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 have a lot of work cut for us, but we're enthusiastic about next year, we expect to have approximately 1,400 children, aged one to seven, enrolled globally in our Phase three trials |
| Be assured that study start-up activities with our CRO have already begun so that we will be in a good position, to initiate the study at an optimal time |
| The point here being that intervening early in peanut allergy is important, our technology's important, creating much interest, and obviously that's the most validating feedback there is on the hardware that's been going in, which I'd like to use to just again reinforce our commitment to this space and to the importance and the benefit of generating plenty of the data and plenty of long-term data |
| However, that's behind us now and we expect to build momentum and complete screening by Q3 this year |
| But that was why we were very happy when the agency agreed, that these would be two separate BLAs |
| This confirms, what was observed previously, and also provides reassurance that slightly older subjects of three year olds and EPITOPE that crossed over as four year olds in the Open-Label extension some had a robust treatment effect |
| The study is progressing well against the forecast we had in place assuming that the sales were up and running, we've been up and running there as expected |
| 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 |
| Again, we hope that we will keep on conveying the success of our programs to 2023 and 2024 |
| In the interim data, from the Open-Label Extension to EPITOPE, we observed continued improvement and treatment response following the 2nd year of treatments, which is consistent with our previous Open-Label Extension data in four to 11 years olds |
| Kevin will be instrumental to a successful BLA submission, and I couldn't be more thrilled that he has joined our leadership team |
| And we believe from the pace of no response e-mails everything else that they are -- this is a top priority |
| So that test is set up to provide another large robust dataset unmatched by any other peanut allergy study in this age group |
| Wish you a good evening |
| Statement |
|---|
| And lastly, I want to apologize again profusely for a call that started later than expected |
| These data suggest that Viaskin Peanut is potentially rewiring immune systems and we suspect that is due to a plasticity immune system in this age group |
| This contract was draining resources and attention away from our priority Viaskin Peanut, with neither tangible nor medium-term income |
| And so the system wasn't quite worked out, and I think there was a just a glitch here and there |
| Cheese: and especially so allergic to mount that any of the residual Pizza Cheese Greece that's on there |
| But again, it's a pretty extreme case |
| Local application site reactions were the most commonly reported adverse events, though notably the frequency of such reactions decreased in the 2nd year of treatment with Viaskin Peanut |
| 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 |
| 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 |
| It took much longer today |
| We believe the food challenge was the best way to ensure that outcome, unit-specific IgE is more reliable as a biomarker of peanut allergy in older children, but is less reliable in toddlers |
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