Full Year 2023 DBV Technologies SA Earnings Call
Operator: Very shortly. Thank you.
Okay.
[music].
Andrew Campbell: ??? ??? ??? ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? www.adr.co.uk © BF-WATCH TV 2021, Hello, everybody. Our presentation will be starting shortly. We are just waiting for the 10k to be filed and we apologize for the delay. ANDREW CAMPBELL, ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??? ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Sponsored by ADR, www.adr.co.uk ADR ADR ADR ADR ADR, © BF-WATCH TV 2021 Sponsored by DBV, ??? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? www.adr.co.uk © BF-WATCH TV 2021, Sponsored ADR CONGRATULATIONS TOThoseWhoBecame.be, © BF-WATCH TV 2021 © BF-WATCH TV 2021 Sponsored ADR, © BF-WATCH TV 2021 WOLLEBEN, Daniel Tass, Pharis Mohideen, Rajan Sharma, Katie Matthews, DBV Technologies WOLLEBEN, Daniel Tass, Pharis Mohideen, Rajan Sharma, Katie Matthews, DBV Technologies WOLLEBEN, Daniel Tass, Pharis Mohideen, Rajan Sharma, Katie Matthews, DBV Technologies, Are you guys still there? Our experience is that 6 o'clock is really too late to have a call. I mean, we could, you know, in the future, we could... Yeah.
Hello, everybody.
Our presentation will be starting shortly we are just waiting for the 10-K to be filed and we apologize for the delay.
[music].
Yeah.
[music].
[music].
Yes.
Any point in telling people will do to call. It takes some spin or one thing people winning as one thing I'm sorry, we increased close when they close it takes time for that.
Okay.
Speaker Change: Sorry, just a minute.
Speaker Change: Our experience is that that six o'clock is really too late to have to have a call I mean, we could pursue.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: In the future we could.
Speaker Change: Yes.
Operator: Yeah.
Operator: [music].
Andrew Campbell: Okay.
Operator: The design of our anticipated clinical trials.
Operator: Timing and results of interactions with regulatory agencies, our forecast of our cash runway and the ability of any of our product candidate if approved to improve the lives of patients with food allergies. These.
Andrew Campbell: 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 S E T and the French Ams.
Andrew Campbell: 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.
Andrew Campbell: 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. After this call.
Andrew Campbell: Joining me on the call today are Daniel TASS, a chief Executive officer of GBP Dot to Forest Modine, Abb's, Chief Medical Officer, and the Ginnie Casino, our Chief Financial Officer.
Speaker Change: Before handing the call over to Daniel but there was a few who may be new to television we are developing bias skin.
An investigational proprietary technology platform with broad potential applications as an immunotherapy for the treatment of food allergies, and other immunological disorders with <unk> peanut as our lead candidate <unk>.
I'll pass the call over to Daniel.
Speaker Change: Yeah.
Thank you and thank you everyone again I need to have my apologies, we would inputs confirmation that the kids have been uploaded it usually takes a minute. It took much longer today, we will obviously dig into this and make sure. It doesn't happen again, so my apologies.
Speaker Change: Having you on hold for 30 minutes.
Speaker Change: Today, we'll obviously give you an update on our progress when it comes to our <unk> programs and regulatory pathway and then Bruce will share with us a financial update.
Speaker Change: But before we do that I'd like to share with you a few perspectives about the virus and peanuts and the peanut allergy market.
We have not discussed in a while.
Speaker Change: Studying the fact that last week.
Speaker Change: DVD attended the American Academy of allergy asthma Immunology annual scientific meeting, which was held in Washington D. C. The meeting which is known to Quad AI.
Speaker Change: Please regard as the premier events.
Speaker Change: In the allergy immunology community and every year, we have a lot of boots on the ground at Quad AI to listen engage with all of our key stakeholders allergists.
Speaker Change: And patient advocacy groups.
Speaker Change: Our very top of that list one of the highlights.
Speaker Change: Of quality or this year was the fact that the product theaters, which had been to quad AI. The product theaters are the big deal and attract a lot of traffic.
The one we hosted was called importance of early intervention for peanut allergy.
Speaker Change: But I am very proud of the fact that haven't presented attendance. In fact, we're told that we broke the record for Coty I Eh events.
Speaker Change: And the best attended product theater ever.
Speaker Change: The room here 125 people to inventory allergist or more shored up.
Speaker Change: The point here being that.
Speaker Change: Intervening early in peanut allergy is importance our technology's important create much interest and obviously that's the most validated feedback there is all the hard work that's been going in.
Which I'd like to use to just again to reinforce our commitment to this space.
Speaker Change: And two the importance and the benefit of generating plenty of data and plenty of long term data.
Speaker Change: We understand and we.
Speaker Change: We understand the huge responsibility we have.
Speaker Change: Of establishing the long term safety and clinical benefit.
Speaker Change: And peanuts, because treating children is an important responsibility.
Speaker Change: Our open label extension amendment to patients, while it takes time and effort and financial resources ensures.
A rich population of subjects on bias and peanuts.
Speaker Change: <unk> treatment inform options and optimize outcomes for our patients.
Speaker Change: And we do have extensive follow up of our subjects.
Speaker Change: You may recall.
Speaker Change: We recently reported back in November our interim year, two data from our open label extension study and toddlers.
Speaker Change: Obviously, we cannot wait to see what the Euro treaty that will look like when we share that later on this year.
Speaker Change: In 2020 forward will continue to work towards Scream, a robust data package in total was in children.
Speaker Change: We have a lot of work cut for us, but when it too as you're asking about next year. We expect to have approximately 1400 children, aged one to seven enrolled globally in our phase III trials.
Speaker Change: All our phase III studies have an open label extension.
Speaker Change: As I mentioned just now is.
Speaker Change: So understanding long term treatment and the benefits of our therapy.
Speaker Change: And it goes without saying, we will have the largest cumulative exposure to investigational product ever in pediatric food allergy is going to be a massive safety database.
Speaker Change: Our 1% to seven year olds, who have been in fact close to 1700 subjects on active treatment.
We combine that with the data from our prior phase III trials.
Speaker Change: We break this down with approximately 600 toddler patient system to toddlers age one to three and about 100 patients age four to seven.
Speaker Change: I've been on immunotherapy for up to three years.
Speaker Change: And let's not forget all the work we've done in courts 11 before them.
Speaker Change: Where are some of those children were treated with <unk> for up to five years. In fact, some of that data was shared at Quad AI last weekend.
Speaker Change: Assume it all up and put us in perspective.
Speaker Change: Over $1 million.
Speaker Change: Skin patches have been applied to children age one through 11 clinical.
Speaker Change: Development program, that's obviously more than one millions days of therapy that makes up the safety database of this product safety and efficacy database with this product.
Speaker Change: It is as I said, the most comprehensive research in children with peanut allergy.
Speaker Change: Well studied product to demonstrate efficacy and consistently favorable safety profile, we're proud of that and we keep on building a database.
Speaker Change: The second point I wish to touch on today.
Speaker Change: Is the disease modifying potential device and peanuts.
Speaker Change: I like to share with you data that's been discussed in the past, but put together I think as an important perspective here.
Speaker Change: Let's start with our recent and striking observation and toddlers from year two of our ongoing open label study.
Speaker Change: <unk> extension study.
Speaker Change: Data showed that approximately three out of $5 to consume almost three five grams of peanut protein without triggering stopping symptoms during the food challenge.
Speaker Change: That is the equivalent of 12 to 14 peanuts way beyond what we anticipated during accidental exposure and a massive jump from what was a median.
Speaker Change: Eliciting dose at baseline of 100 milligrams.
Speaker Change: These data suggest that <unk> is potentially rewiring immune systems and we suspect that is due to a pastis city immune system in this age group.
Speaker Change: We also have two other data that's from prior studies showing the device can peanut can induce what is known as sustained on responsiveness to the allergan in the older children, who after two to three years of treatment, 80% of participants maintain desensitization of a 1000 milligrams or more.
Speaker Change: Two months after stopping treatment.
Speaker Change: And thirdly, we know from our studies in animal models and the data suggests the braskem induces sustained on responsiveness of the Allergan by modulating BMP genetic signature.
Speaker Change: Specific T cell compartments remember western Peanuts has a unique mode of action that leverages the skins in your properties induce tolerance.
Speaker Change: And there is no other product.
Speaker Change: I was there that shows that motive action.
Speaker Change: With all this in mind, while this is not the indication would be pursuing at approval, we fully intend post approval and as part of our long term commitment to these children.
Speaker Change: To explore avastin peanuts is fundamentally is disease modifying after a few years of treatment.
Speaker Change: With that as background on our commitment to science into our patients I will turn the call over to Sara <unk>, Our Chief Medical Officer for a detailed update on our two best Internet programs.
Sara: Thank you Danielle.
Sara: As a reminder, we intend to submit two separate delays for the treatment of peanut allergy in.
Sara: In the one to three year olds, who are using the original square patch.
Sara: The 12 month efficacy study epitope, just completed and the results were published in the New England Journal of Medicine.
Sara: And the pre BLA meeting held in April of 2023. After it does not request any additional efficacy data, but did request a supplemental safety study to increase exposure on active product to close to 600 subjects per icu's guidelines.
Sara: As Claire left there was not looking for a specific safety signal.
Specific to concern.
Sara: We call. This six months safety study comfort toddlers.
In parallel we are running the four to seven year old indication with the modified circular patch.
Sara: We started this program last year with a 12 month study.
Sara: Recruitment is ongoing at this time.
Sara: This indication will also have a six month supplemental safety study, which we call comfort children.
Sara: The two studies combined will have 600 subjects on active treatment to Miss the <unk> guidelines.
Sara: So.
Sara: Our attention this year, we will be focused on completing recruitment for vitesse and starting our two supplemental safety studies.
Sara: As Daniel mentioned.
Sara: <unk> has always been committed to generating the most robust data set as possible in our clinical trials.
Sara: <unk> is no exception.
Sara: We recently submitted an amendment to extend the open label phase. So that every subject enrolled in the trial has the opportunity to receive Boston P&L for up to three years.
And remember we also have our expanded access program for subjects have completed treatment.
Sara: A BBB clinical trial and want to continue to receive <unk> and peanuts.
Sara: So the test is set up to provide a another large robust dataset unmatched by any other peanut allergy study in this age group.
Sara: Recall that the population and the test is considered to be more sensitive than subjects in our previous studies with the inclusion of eliciting dose set at 100 milligrams.
Sara: This is aligned with a younger four to seven year old age group, where we believe Boston peanut can provide great clinical benefit.
Sara: And protests, we have 86 clinical centers spread across the U S, Canada, Australia and Europe.
Sara: In every country are open and actively recruiting subjects.
Sara: Like other sponsors we were set back by the EU European clinical trials directive, which significantly delayed our opening of our European sites.
Sara: However, that's behind US now and we expect to build momentum and complete screening by Q3 of this year.
Sara: That brings me to the comfort children supplemental safety study in four to seven year olds.
Sara: This will have a six month core period, followed by an open label extension that will provide an additional six months of treatment for subjects randomized to active products.
Sara: And 12 months of treatment for subjects randomized to placebo.
Sara: Every subject will have the opportunity to receive buskin peanuts for a full year.
Sara: This will be a 270 subjects study randomized three to one active to placebo.
Sara: The main inclusion criteria will be based on skin prick tests and peanut specific ige levels.
Sara: These criteria are sufficient.
Sara: To ensure a similar patient population relative to the tests.
Sara: Thus there is no need for a food challenge as part of the inclusion criteria.
Sara: One of the differences and comfort children relative to the test is the use of a simplified instructions for use.
Sara: The safety study a few states each Dvds 71 to 250 microgram epic cutaneous system is intended to.
Sara: To be warm for a full day 24 hours.
This is a shift away from the 24, plus minus four hours per day and the minimum wear time used in previous studies.
Sara: This new <unk> more accurately reflects allergen immunotherapy and how we expect our product to be label if approved.
Sara: Based on your past similar safety study with <unk>.
Sara: <unk> and <unk> 11 year olds.
Sara: We believe comfort children would be an attractive study with potential subjects and at research centers.
Sara: They're short 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.
Speaker Change: Okay, let's move to the top of the program.
Speaker Change: The results from the first 12 months of the Epitope study were published last year in the New England Journal of Medicine.
Speaker Change: The open label extension to episode is ongoing.
Speaker Change: Recall that all subjects have the option to receive basket for up to three years.
Four subjects originally randomized to active treatment, we have data for two years on treatment.
Speaker Change: And for those randomized to placebo, we have the one year crossover data from placebo to active.
Speaker Change: These data were presented as the very first ever late breaker at the <unk>.
Speaker Change: <unk> College of allergy asthma, and immunology annual meeting last November.
Speaker Change: In the interim data from the open label extension to Epitope, we observed continued improvement and treatment response following the second year of treatment, which is consistent with our previous open label extension data in four to 11 year olds.
Speaker Change: Using the responder criteria and epitope the response rate increased from 67% to almost 84%.
Speaker Change: Four out of five subjects, 81% consumed on eliciting dose of greater than or equal to 1000 milligrams.
Speaker Change: To put this into perspective, the median eliciting dose that baseline was 100 milligrams.
Speaker Change: A 10 fold increase.
Speaker Change: Finally.
Speaker Change: Participants consumed 56% of participants consumed the entire food challenge of nearly three five grams or about 14, peanuts kernels without meeting the food challenge stopping criteria.
Speaker Change: We believe these are really impressive results that continued to build upon our extensive and robust baskin peanuts clinical datasets.
Speaker Change: During the second year of treatment the safety results and targets were entirely consistent with trials in older children, which demonstrated a well tolerated predictable safety profile.
Local application site reactions were the most commonly reported adverse events, though notably the frequency of such reactions decreased in the second year of treatment with <unk> peanut.
Speaker Change: No subjects had treatment related serious treatment emergent adverse events during the second year of treatment with <unk> and peanuts.
Speaker Change: And no treatment related permanent study discontinuation occurred.
Speaker Change: Furthermore, there were no treatment related anaphylactic events during the second year of treatment with <unk> and peanuts.
And remember.
Our studies used a very broad definition of anaphylaxis first.
Speaker Change: Principally behind to set a very low bar and reporting anaphylactic events.
Speaker Change: Overall, we were extremely pleased with the results of the second year of treatment from an efficacy point.
Speaker Change: As well as from a safety point.
Speaker Change: Didn't present, the placebo crossover data in the slides today, but it was discussed at the college meeting in November.
Speaker Change: And the placebo crossover efficacy and safety appeared to be virtually identical to the first 12 months dataset and epitope that was published in the New England Journal.
Speaker Change: Okay.
Speaker Change: Firms what was observed previously and also provides reassurance that slightly older subjects for three year olds and epitope that crossed over as for euros and the open label extension.
Speaker Change: <unk> had a robust treatment effect.
Speaker Change: This bodes well for the test study.
Speaker Change: Let me wrap up with the toddler comfort toddler study.
Speaker Change: This is a six month study.
Speaker Change: Will include 400 subjects randomized three to one active to placebo.
Speaker Change: Like the comfort children study subjects will have the opportunity to receive active treatment for up to one year.
Speaker Change: Others will use the same view as comfort children.
Speaker Change: So there will be consistency between the two studies.
Speaker Change: This study will use the same square patch as the epitope study.
Speaker Change: One of the differences between comfort toddlers and comfort children other than the obvious difference in age range and patch is that the toddler study will use a double blind placebo controlled food challenge as part of the inclusion criteria.
Speaker Change: We chose to include a food challenge to ensure that the study population in the safety study would be as closely matched to that as episode as possible.
Speaker Change: We believe a food challenge was the best way to ensure that outcome.
Speaker Change: And it's specific RGB is more reliable as a biomarker of peanut allergy in older children, but is less reliable and toddlers.
Speaker Change: Our epitope data shows that half of our subjects had peanut specific ige levels at or below <unk>, but still tested positive for peanut allergy by food challenge.
Speaker Change: That is they had low agg levels.
Speaker Change: But we're still allergic.
Whereas the older subjects in the middle and far right figures on the slide had much fewer subjects with low <unk> network peanut allergic.
Speaker Change: We appreciate that this as a bit of complexity to the study and then 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.
Speaker Change: As we have stated previously we will initiate comfort partners. After we received FDA feedback on the protocol, which was submitted in November last year.
Speaker Change: The <unk> clinical team has been gearing up with our zero for study initiation.
Speaker Change: We believe we are in position to initiate this study in a short period of time.
Speaker Change: Pending FDA feedback on the protocol.
With that back to you Daniel.
Daniel Tass: Thank you Harris.
Daniel: Before turning the call over to <unk>, you need to review the financials I'd.
Daniel: I'd like to cover a corporate update.
Daniel: In 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.
Daniel: On top of our new CFO that is unique.
Daniel: Who joined US in November we appointed Dr. Kevin <unk> Phd as our new Chief Operations Officer, Ken.
Daniel: Kevin has an extensive track record of more than 35 years.
Daniel: In biopharmaceutical strategic and operational leadership roles, including roles that span both research as well as drug development and drug approval.
Daniel: Kevin will be instrumental to a successful BLA submission and I couldnt be more thrilled that he has joined our leadership team.
I would like to see the opportunity.
Speaker Change: Formally welcome Kevin to our team.
Speaker Change: And he's already making a very positive impact could be delighted to have both the Virginian Kevin joining us.
Speaker Change: Without further Ado, we'll invite good is unique to cover.
Speaker Change: Our financial highlights.
Kevin: Very much Danielle.
Speaker Change: This brief overview of our financial goals for the year.
Speaker Change: Consequently for free.
Speaker Change: Q2 further leaving you in our press release sometime.
Danielle: The three highlights I would like to point out.
Danielle: Number one we closed the year with $141 million in cash.
Danielle: And for Q, we dedicated over 90% of the cash we used in operation to progressing by asking peanuts clinical development and preparing coffee at a site.
Danielle: Number three our 2023 P&L, including the favorable impact of the termination of our collaboration with Nestle as.
Danielle: As you may be aware in quite a fall last year 2020 shrink it terminated collaboration agreement with Nestle, which was meant to develop and commercialize diagnostic mascara because milk allergies.
Danielle: This contract was training resources and attention away from our priority.
Danielle: And peanuts with neither tangible now medium term income.
Danielle: Terminating the contract with a financially sound decision with material positive impact on the 20 <unk>.
Danielle: <unk> expenses and net loss.
Danielle: One little add on our financials and resources allocation, if you consider our financial statements without the impact of initial collaboration agreement.
Danielle: <unk> expenses increased by 25% in 2022.
Danielle: To support deeply clinical labs contain a clinical study CMC preparation regulatory activity and getting ready to pump from the manufacturing site.
Danielle: Although this filing approval and launch of <unk>.
Dan: Back over to Dan.
Dan: Yes.
Dan: Thanks Rajeev.
Dan: Now before communicate DVS upcoming milestones I would BMS, but did not take a moment here to appreciate how much the food allergy landscape has changed in the past few years and we believe in peanut will serve that community.
Speaker Change: Theres nothing we hear more clearly from the food allergy community.
Speaker Change: This therapeutic area desperately needs treatment alternatives.
Speaker Change: The recent FDA approval of <unk> permanently zoom hub.
Which was the brand name Xolair.
Speaker Change: For the treatment of food allergy, ensuring adult is a welcome addition.
Speaker Change: We see treatment for food allergy recording a range of options just like other.
Speaker Change: Immunological conditions, such as asthma, atopic dermatitis or inhaled allergies.
Speaker Change: And I'm asking you shoot to imagine.
Speaker Change: The position of apparent with a young child is diagnosed with peanut allergy the Pediatrician's office or the outrageous offers until very recently stopped there the only option available to concern parents and caregivers was avoidance.
Speaker Change: Intelligent readiness with <unk> auto injector.
Speaker Change: Today is a different story and over time, we'll keep on getting different better treatment or now channel to the Allergist's office, what are they and their families can have real conversations as illustrated here.
Speaker Change: <unk>.
Speaker Change: All the conditions and all the circumstances that surround.
Speaker Change: The LIFO that shot in that family.
Speaker Change: And that was another topic that we picked up in talking with Kols and experts at Quad AI.
Speaker Change: Having a range of treatment options available only fuels that conversation.
Speaker Change: And for the 670000 children in the U S Ages, one through seven currently living with the daily burden of a peanut allergy every patient story and situation is unique.
Speaker Change: <unk> is a bespoke solution.
Speaker Change: And that's what's needed here simply put one size will not fit all.
Speaker Change: Yeah.
Speaker Change: In an ever evolving market and we want to be very much part of that evolution basket and it will always be a very important product in fact, it will be.
Speaker Change: Opinion of most a foundational products.
Speaker Change: As was evidenced after speaking with hundreds of outages attending <unk> conference.
Speaker Change: 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 DVD.
We anticipate initiating the first subject of our comfort Targeters trial six months supplemental safety trial in support of the BLA.
Speaker Change: We also anticipate completing enrollment of our ongoing <unk> phase III efficacy trial in children, aged four through seven years of age.
Speaker Change: And once this this enrollment is close to completion, we'll initiate recruitment for our six months comfort children trial in support of that BLA.
<unk> as far as touched on will be carefully time, so as not to compete for the same 70 subjects across too.
Speaker Change: Different clinical trials.
Speaker Change: During the second quarter.
Speaker Change: 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.
Speaker Change: We also plan to announce the three year results from our ongoing phase III open label extension of Backstop trial.
Speaker Change: Later on this year.
Speaker Change: And finally.
Speaker Change: The publication in Science and Medical Affairs, Michelle Dbz continues to be operating very actively anticipate publication of additional scripts, which includes publications of the results of the year or two open label extension of Epitope, which Paris showed a few minutes ago.
Speaker Change: And additional invited review with a peer reviewed scientific journal as well as submitting abstracts of new results presentation and upcoming conferences. So we'll keep on publishing a lot of data on.
Speaker Change: On our technology.
Speaker Change: With that well now.
Speaker Change: Now ask paresthesia is you need to join me for the Q&A and operator, if you could open up going for questions.
Speaker Change: That'd be great.
Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.
Speaker Change: We are using a speakerphone please pick up your handset before pressing the keys.
Speaker Change: Is it any time your questions and interest and he would like to withdraw your question. Please press Star then two.
Our first question comes from John Sullivan with citizens JMP. Please go ahead.
John Sullivan: Hey, good afternoon, and thanks for taking the question questions sorry.
John Sullivan: First I was hoping you could give a little bit more color on the EU Directive and then also could you comment on how many of the 600 expected patients in <unk>.
John Sullivan: Already enrolled to date.
Ferrous: I'll have ferrous answer the question on the directors.
Ferrous: So hey, John insurers. So this new directive is a little bit different from how things were done in the past so yeah.
John Sullivan: You have to submit your dossier your protocol and the countries that you've selected in Europe, all our banded together essentially as one country. So.
John Sullivan: No.
John Sullivan: In the past you could go one off to Germany, if they stay in whichever country you want to in this case. They are all bundled into one so if any country has any objection. It has to go all the way to be resolved and that process can continue almost indefinitely.
John Sullivan: And the Big difference here is if one country protests and Hasnt issue all of the countries are stock they can't participate and you can't pull out and one off bill separately into all the different countries.
John Sullivan: So it is a bit different and I think the challenge here was we were one of the first phase II protocols that went through.
John Sullivan: So the system wasn't quite worked out and I think there was a just a.
John Sullivan: Glenn Sharon there and as these new things come through they're not always well oil. So that's the nature of the difference in the directive now versus how it was in the past.
Speaker Change: Got it can you comment how many can you comment on how many of the expected 200 patients have been enrolled so far.
Speaker Change: Yeah, we don't provide that clarity or guidance for competitive reasons here. The study is progressing well.
Speaker Change: Against the forecast we have in place assuming that these sites were up and running and they've been up and running later than expected. What I can share is we expected 60 to 90 days would be sufficient to get through the new directive process. It took us closer to actually to exactly nine months to go through it.
Speaker Change: And that explains why we are out of abundance of prudence.
Pushing the.
Speaker Change: The expectation of glass patient screen from.
Speaker Change: First half of 2000, and Q2 of 2024 to Q3 of 2024.
Speaker Change: Got it okay, and any timing guidance on one comfort colors will be starting and then how do you think about the parallel programs do you want them to be exactly parallel with BLA submission.
Speaker Change: I'm curious does that make it easier for Europe, essentially the review division or could there be staggering and one coming before the other.
Speaker Change: Yes, so I'll have first answer the first question on comfort toddlers and I'll talk about the benefits of having the two programs in parallel here.
Speaker Change: As we've always said, we will start our phase III programs.
Speaker Change: When we have FDA feedback.
Speaker Change: So we're waiting for the FDA feedback.
Speaker Change: We've done all the preparations we can in terms of the team and the <unk> being ready to go once we get that feedback. So we believe it will be a short for a turnaround.
Speaker Change: From a clinical standpoint, so again.
Speaker Change: <unk>.
Speaker Change: And just the right thing to do for Phase III trials get FDA feedback and alignment before we start to run.
Speaker Change: And we are in communication with them and they reinforce to us and we believe from the pace of no response to e-mailed everything else that they are they say, it's a top priority we very much see that.
Speaker Change: But we're just waiting for that final sign off before starting this study out of again.
Speaker Change: Cummins is prudent.
Speaker Change: And then I had a question to come back to them.
Speaker Change: The benefits of the two doses in parallel.
Speaker Change: Yes, yes.
Yes. Please.
Speaker Change: Both markets are you. So if it was essentially coming down too.
Speaker Change: Raised two commercial potential rate them even.
Speaker Change: Quite simply.
Speaker Change: Obviously the program in <unk> is more straightforward is only one study to run.
Speaker Change: While we have to to run with.
Speaker Change: And four to seven year olds, but that was why we were very happy with the agency agreed that these would be two separate BLA, making not one to be junior to the other by being the BLA in the supplemental BLA.
Speaker Change: And thus whichever one you can file for US we will file first.
Speaker Change: And making us as a commercial matter.
Indifferent to which one is wafers.
Speaker Change: Okay and then just.
Speaker Change: Last one for me I know you touched on this the Xolair approval can you discuss how.
Speaker Change: Allergists do you speak to or thinking about peanuts use versus all or use do you think there is an overlap between the patients that may like both or do you think these are going to be separate addressable markets based on product profiles and I'll jump back in the queue. Thanks.
Speaker Change: Yeah, I'll have parents give you more detail because he start where we've always talked a bunch of averages that quality, but.
No there's very little overlap between the two markets, which is why zelle.
Xolair is approval is important here by offering options of the populations are pretty significant difference with Sarasota showed that what you've learned from them.
Speaker Change: Sure. So we spent quite a bit of time the quarter talking to are different.
Speaker Change: Sites.
Speaker Change: And let's say take home message, we're getting from them is that.
Speaker Change: Lola has been approved a long time and it has been used off label with <unk>.
Speaker Change: In certain situations.
Speaker Change: And there hasn't been huge huge off label use for peanut allergy as a stand alone indication or even multiple food allergies and the reason for our 1% to seven year olds. The way we've been told is especially on the toddlers one to three.
Speaker Change: None of the investigators we spoke to would use it as sort of monotherapy for multiple food allergies or single for dollar just because it's a total population.
Speaker Change: And what it would do or.
Speaker Change: Noon system that is evolving very immature and of course, it's an injectable.
Speaker Change: In the older patients, maybe six or seven.
Speaker Change: What we've heard was there could be extreme extreme cases of patients or ultra ultra sensitive. So the anecdote that was told to me was.
Speaker Change: Practitioner has a patient who could go to chucky cheese, and especially and so allergic to milk that any of the residual.
Speaker Change: Pizza cheese grief that's on there.
Speaker Change: And if they had touched them all for their eyes that would go into an anaphylactic reaction and this is just almost straight rebate on what this investigator told me in for a case like that where its well documented.
Speaker Change: <unk> is just extreme and they've tried to avoid and done everything they can.
Speaker Change: That patient might be a candidate for omalizumab, but again, its a pretty extreme case and they don't tend to overlap with our patients very much at all I don't know if that helps or Jonathan but that's just what we've gathered as anecdotes talking to as many of the investigators as we can to get an understanding of how the product may be used.
Speaker Change: No that's consistent with what we're hearing as well so for the ore feed.
Speaker Change: That can color guys.
Sure Yes.
Speaker Change: The formal market research also besides Taylor with Kols shows yes.
Speaker Change: To be used in older kids and adolescence or young adults or multi allergic at times in their lives where.
Speaker Change: You want to make sure that their behavior or whatever they are experiencing is covered.
Speaker Change: It's not the population that we wish to help with our product.
Okay.
Speaker Change: Again good luck.
Speaker Change: Great.
Speaker Change: Again, if you have a question. Please press Star then one our next question comes from Sheila.
Sheila: <unk> Hernandez ban Landshark Camden. Please go ahead.
Sheila: Yes. Thank you for taking my question.
Sheila Hernandez: Could you just walk us through the steps that has to get to the BLA filing for the bottlers and the second question does your cash runway until the end of the four includes the start of both safety study. Thank you.
Speaker Change: Good question.
To answer the second part of your question is yes, our forecasts have always been as you know rather smart and conservative. So this assumes the not only the initiation.
Speaker Change: Those two studies a continuation of the desk a lot of work. We're doing also when it comes to regulatory dossiers CSA.
Speaker Change: CMC and building up inventory also so theres a lot of our expenses this year are going to that.
Speaker Change: As far as next steps for their toddler dose.
Speaker Change: Sign off from the FDA on the protocol.
Speaker Change: And then initiation of the trial as service says we've been in dialogue with many of the investigators sides, we can turn that around pretty quickly.
What we don't know is how quickly the study will enroll we know theres a lot of enthusiasm for that study, we know that food challenges, especially only one that entry in toddlers.
Speaker Change: Easier to do much easier to do than food challenges in older children.
Speaker Change: So we're confident this study will enroll at a good pace.
Speaker Change: But we have no analogues here and for that reason, we're going to leave that as an open question until we have more data.
Speaker Change: More precisely to study completion BLA filing.
Speaker Change: We expect though that once we have the clinical data to move to filing a BLA with move rather quickly.
Speaker Change: The CMC work will be done by then.
Speaker Change: And it's not a complex dose here by the way rates there. So it's pretty straightforward when it comes to the clinical data that we have the blurred lines.
Answering your question Steven.
Steven: Yes. Thank you.
Steven: This concludes our question and answer session I would like to turn the conference back over to Daniel.
For any closing remarks.
Daniel: Covered a lot today and thanks for those questions so to recap.
Daniel: We're continuing to advance the test phase III study.
Daniel: In peanut allergic children four to seven in parallel the successful completion of the supplemental come through safety studies are important.
Daniel: And as just shared with you.
Daniel: Our colleagues asking questions here.
Daniel: We have two BLA there are distinct and in parallel.
Daniel: One is relating to the other ones and the moment that we have signed off on the protocol and toddlers, we will initiate that study as well lined up.
Daniel: We are very confident we remain very confident this work will support BLA is in both age groups.
And as we've picked up from dialogues with.
Daniel: Allergists at Quad AI will pick up when it comes to talk and investigators.
Daniel: Pick up in our market research.
Daniel: Our families want treatment options the more treatment options are available.
Dynamic of the market will be and we all benefit from that.
Speaker Change: And this concludes our call for today.
Speaker Change: <unk>.
Speaker Change: We hope that we will keep on conveying the success of our programs through 2023 into 2024, we're laser focused on execution.
And lastly, one apologize again profusely for a call that started later than expected.
Speaker Change: Wish you a good evening.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.