DBV Technologies Q4 2023 Earnings Call Transcript

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Provided by Quartr
March 7, 2024

There are 7 speakers on the call.

Operator

Apologies for the late start of our conference. Welcome to the DBV Full Year 2023 Financial Results and Business Update Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded.

Operator

I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Speaker 1

Thank you. And again, our sincere apologies for the delay in starting today. This afternoon, BBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31, 2023. This press release is available in the Press Releases section of the DBV Technologies Web site. 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 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 1

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 AMS 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 statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Daniel Tasse, Chief Executive Officer of DBV Doctor.

Speaker 1

Faris Mohdine, DBV's Chief Medical Officer and Virginie Groussina, our Chief Financial Officer.

Speaker 2

Before handing

Speaker 1

the call over to Daniel, for those of you who may be new to DVV, we are developing Vioskin, an investigational proprietary technology platform with broad potential applications as an immunotherapy for the treatment of food allergies and other immunological disorders, with Via Scarpino as our lead candidate. I will now pass the call over to Daniel. Daniel?

Speaker 3

Eddie, Deane, thank you, and thank you, everyone. Again, I need to add my apologies. We were waiting for confirmation that the K had been uploaded. It usually takes a minute. It took much longer today.

Speaker 3

We will obviously dig into this and make sure it doesn't happen again. So my apologies for having you on hold for 30 minutes. Today, we'll obviously give you an update on our progress when it comes to vysimpedina programs and the regulatory pathway, and then Virginie will share with us a financial update. But before we do that, I'd like to share with you a few perspectives about Vy in peanuts and the peanut allergy market, things that we have not discussed in a while. Starting with slide that last week, DVV attended the American Academy of Allergy, Asthma, Immunology Annual Scientific Meeting, which was held in Washington, D.

Speaker 3

C. The meeting, which is known at AAAAI, is regarded as the premier event in the allergy immunology community. And every year, we have a lot of boots on the ground at AAAAI to listen, engage with all of our key stakeholders, allergists and patient advocacy groups

Speaker 4

at

Speaker 3

the very top of that list. One of the highlights of AAAAI this year was the fact that the product year, if you've been to AAAAI, the product theaters are a big deal and attract a lot of traffic. The one we hosted was called Importance of Early Intervention for peanut allergy. And I'm very proud of the fact that had an unprecedented attendance. In fact, we're told that we broke the record for core AI event and the best attended product theater ever.

Speaker 3

The room held 125 people, 230 allergists or more showed up. The point here being that intervening early in peanut allergy is important. Our technology is important, creating much interest. And obviously, that's the most validating feedback there is all the hard work that's been going in, which I'd like to use to just again reinforce our commitment to the space and to the importance and the benefit of generating plenty of data and plenty of long term data. We understand and we understand the huge responsibility we have of establishing the long term safety and chemical benefits of VIA Skin Peanut because treating children is an important responsibility.

Speaker 3

Our open label extension commitment to patients, while it takes time and effort and financial resources ensures a rich population of subjects on Bioske and Peanuts to guide treatments, inform options and optimize outcomes for patients. And we do have extensive follow-up of our subjects. You may recall, we recently reported back in November our interim year 2 data from our open label extension study in toddlers. And obviously, we cannot wait to see what the year 3 data will look like when we share it later on this year. In 2024, we will continue to work towards creating a robust data package in toddlers and children.

Speaker 3

We have a lot of work cut for us, but we're enthusiastic about it. Over the next year, we expect to have approximately 1400 children aged 1 to 7 enrolled globally in our Phase 3 trials. All our Phase 3 studies have an open label extension, which as I mentioned just now is key to understanding long term treatment and the benefits of our therapy. And it goes without saying, we will have the largest cumulative exposure to investigational product ever in pediatric food allergies. It's going to be a massive safety database.

Speaker 3

For our 1 to 7 year old, we will have in fact close to 1700 subjects on active treatment. And if we combine that with the data from our prior Phase III trials, we to break this down, we'll have approximately 600 toddlers aged 1 to 3 and about 1100 patients aged 4 to 7 who have been on immunotherapy for up to 3 years. And let's not forget all the work we've done in 4 to 11 before that, where some of those children were treated with biosimilar for up to 5 years. In fact, some of that data was shared at AAAAI last weekend. To sum it all up and put this in perspective, over 1,000,000 BioSkin patches have been applied to children aged 1 through 11 in our clinical development program.

Speaker 3

That's obviously more than 1,000,000 days of therapy that makes up the safety database of this product safety and efficacy database of this product. And it is, as I said, the most comprehensive research in children with peanut allergy. We have a well studied product that demonstrate efficacy and consistently favorable safety profile. We're proud of that and we keep on building that database. The second point I wish to touch on today is the disease modifying potential of biopsy in peanut.

Speaker 3

I'd like to share with you data that's been discussed in the past, but put together I think as an important perspective here. Let's start with our recent and striking observation in toddlers from year 2 that were ongoing open label study extension study. Data showed that approximately 3 out of $5 could consume almost 3.5 grams of peanut protein without triggering stopping symptoms during the food challenge. That is equivalent of 12 to 14 peanuts way beyond what we anticipated during accidental exposure and a massive jump from what was a median, elastane dose at baseline of 100 milligrams. These data suggest that biosyntinib is potentially rewiring immune systems and we suspect that is due to a plasticity the immune system in this age group.

Speaker 3

We also have 2 other data sets from prior studies showing that Viascan peanut can induce what is known as sustained unresponsiveness of the allergen in older children, who after 2 to 3 years of treatment, 80% of participants maintained desensitization of 1,000 milligrams or more 2 months after stopping treatment. And thirdly, we know from our studies in animal models that the data suggests that breast can induce sustained unresponsiveness to the allergen by modulating the epigenetic signature of specific T cell compartments. Remember, Vyasyl Peanut has a unique mode of action that leverages its skinning properties and dose tolerance and there's no other product out there that shares that mode of action. With all this in mind, while this is not the indication we'll be pursuing at approval, we fully intend post approval and as part of our long term commitment to these children to explore a vaccine peanut is fundamentally disease modifying after a few years of treatment. With that as background on our commitment to science and to our patients, I'll turn the call over to Farris, our Chief Medical Officer, for a detailed update on our 2 bioskin peanut programs.

Speaker 5

Thank you, Danielle. As a reminder, we intend to submit 2 separate BLAs for the treatment of peanut allergy. In the 1 to 3 year olds, we are using the original square patch. The 12 month efficacy study Epitope is completed and the results were published in the New England Journal of Medicine. In the pre BLA meeting held in April of 2023, the FDA did 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 ICH guidelines.

Speaker 5

To be clear, the FDA was not looking for a specific safety signal or a specific safety concern. We call this 6 month safety study comfort toddlers. In parallel, we are running the 4 to 7 year old indication with the modified circular patch. We started this program last year with a 12 month VITES study. Recruitment is ongoing at this time.

Speaker 5

This indication will also have a 6 month supplemental safety study, which we call comfort children. The 2 studies combined will have 600 subjects on active treatment to meet the ICH guideline. So our attention this year will be focused on completing recruitment for VITAS and starting our 2 supplemental safety studies. As Danielle mentioned, EBV has always been committed to generating the most robust datasets possible in our clinical trials. Patess is no exception.

Speaker 5

We recently submitted an amendment to extend the open label phase so that every subject enrolled in the trial has the opportunity to receive bioskettena for up to 3 years. And remember, we also have our expanded access program for subjects that have completed a treatment in a DBV clinical trial and want to continue to receive BioSkin Peanut. So the test is set up to provide another large robust data set unmatched by any other peanut allergy study in this age group. Recall that the population in the test is considered to be more sensitive than subjects in our previous studies with the inclusion eliciting dose set at 100 milligrams. This is aligned with a younger 4 to 7 year old age group where we believe VIA Skin Peanut can provide great clinical benefit.

Speaker 5

In VITAS, we have 86 clinical centers spread across the U. S, Canada, Australia and Europe. Sites in every country are open and actively recruiting subjects. Like other sponsors, we were set back by the new European clinical trials directive, which significantly delayed our opening of our European sites. However, that's behind us now and we expect to build momentum and complete screening by Q3 this year.

Speaker 5

That brings me to the comfort children supplemental safety study in 4 to 7 year olds. This will have a 6 month core period followed by an open label extension that will provide an additional 6 months of treatment for subjects randomized to active product and 12 months of treatment for subjects randomized to placebo. Every subject will have the opportunity to receive bioskettena for a full year. This will be a 270 subject study randomized 3:one active to placebo. The main inclusion criteria will be based on skin prick test and peanut specific IgE levels.

Speaker 5

These criteria are sufficient to ensure a similar patient population relative to the test. Thus, there is no need for a food challenge as part of the inclusion criteria. One of the differences in comfort children relative to VITAS is the use of a simplified instructions for use. The safety study IFU states each BBB-seven twelve-two fifty micrograms epicutaneous system is intended to be worn for a full day 24 hours. This is a shift away from the 24 plus minus 4 hours per day and the minimum wear time used in previous studies.

Speaker 5

This new IFU more accurately reflects allergen immunotherapy and how we expect our product to be labeled if approved. Based on a past similar safety study we conducted in 4 to 11 year olds, we believe comfort children would be an attractive study with potential subjects and at research centers. Be assured that study startup activities with our CRO have already begun so that we will be in a good position to initiate the study at an optimal time. Okay. Let's move to the toddler program.

Speaker 5

The results from the 1st 12 months of the Epitope study were published last year in the New England Journal of Medicine. The open label extension to Epitope is ongoing. Recall that all subjects have the option to receive viascan peanut for up to 3 years. For subjects originally randomized to active treatment, we have data for 2 years on treatment and for those randomized to placebo, we have the 1 year crossover data from placebo to active. These data were presented as the very first ever late breaker at the American College of Allergy, Asthma and Immunology Annual Meeting last November.

Speaker 5

In the interim data from the open label extension to epitope, we observed continued improvement in treatment response following the 2nd year of treatment, which is consistent with our previous open label extension data in 4 to 11 year olds. Using the responder criteria in epitope, the response rate increased from 67% to almost 84% and 4 out of 5 subjects 81% consumed an eliciting dose of greater than or equal to 1,000 milligrams. To put this into perspective, the median eliciting dose at baseline was 100 milligrams. That's a tenfold increase. Finally, participants consumed sorry, 56% of participants consumed the entire food challenge of nearly 3.5 grams or about 14 peanut kernels without meeting the food challenge stopping criteria.

Speaker 5

We believe these are really impressive results that continue to build upon our extensive and robust Bioskin peanut clinical data set. 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. 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 Biosk and Peanut. No subjects had treatment related serious treatment emergent adverse events during the 2nd year of treatment with Baskin Peanut and no treatment related permanent study discontinuations occurred. Furthermore, there were no treatment related anaphylactic events during the 2nd year of treatment with fyastempina.

Speaker 5

And remember, our studies use a very broad definition of anaphylaxis purposefully designed to set a very low bar in reporting anaphylactic events. 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 didn't present the placebo crossover data in the slides today, but it was discussed at the college meeting in November and the placebo costs over efficacy and safety appeared to be virtually identical to the 1st 12 month data set in epitope that was published in the New England Journal. This confirms what was observed previously and also provides reassurance that slightly older subjects, the 3 year olds in epitope that crossed over as 4 year olds in the open label extension still had a robust treatment effect. It bodes well for the VITESH study.

Speaker 5

Let me wrap up with the toddler COMFORT toddler study. This is a 6 month study that will include 400 subjects randomized 3 to 1 active to placebo. Like the comfort children study, subjects will have the opportunity to receive active treatment for up to 1 year. Comfort toddlers will use the same IFU as comfort children, so there will be consistency between the two studies. This study will use the same square patch as the epitope study.

Speaker 5

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. We chose to include a food challenge to ensure that the study population in the safety study would be as closely matched to that episode as possible. We believe a food challenge was the best way to ensure that outcome. Peanut specific IgE is more reliable as a biomarker of peanut allergy in older children, but is less reliable in toddlers. 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.

Speaker 5

That is they had low IgE levels, but were still allergic. Whereas the older subjects in the middle and far right figures on the slide had much fewer subjects with low IgG 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.

Speaker 5

We believe we are in position to initiate the study in a short period of time, pending FDA feedback on the protocol. With that, back to you, Daniel.

Speaker 3

Thank you, Faris. Before turning the call over to Birgene to review the financials, I'd like to cover a corporate update. During the Q4, we further strengthened our leadership team in advance of our 2 BLA submissions and anticipated commercialization, so that we are best positioned for long term success. On top of our new CFO, Virgenie, who joined us in November, we appointed Doctor. Kevin Malobiski, PhD, as our new Chief Operations Officer.

Speaker 3

Kevin has an extensive track record of more than 35 years in biopharmaceutical 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, I'm going to invite Virginie to cover briefly our financial highlights.

Speaker 6

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 3 highlights I would like to point out for year 2023. Number 1, we closed the year with $141,000,000 in cash. Number 2, we dedicated over 90% of the cash we used in operations to progressing BioSkin P and L clinical development and preparing for VLA-five.

Speaker 6

Number 3, our 2023 P and L includes the favorable impact of the termination of our collaboration with Nestle. As you may be aware, in quarter 4 but last year, 2023, we terminated a collaboration agreement with Nestle, which was meant to develop and commercialize a diagnostic marker for cow's milk allergy. This contract was draining resources and attention away from our priority via SkinPEA Net with neither tangible nor medium term income. Terminating the contract was a financially sound decision with material positive impact on our 2023 financials expenses and net loss. One more word on our financials and resources allocation.

Speaker 6

If you consider our financial statements without the impact of the Nestle collaboration agreement, our operating expenses increased by 25% in 2023 to support BP clinical biosynthetic clinical studies, CMC preparation, regulatory activities and getting ready from the manufacturing site, in view of all of this for the approval and launch of IV. Back over to you then.

Speaker 3

Thanks, Birgene. Now before I communicate BBB's upcoming milestones, I would be a miss if I did not take a moment here to appreciate how much the food allergy landscape has changed in the past few years and how we believe Basking Peanut will serve that community. There's nothing we hear more clearly from the food allergy community that this therapeutic area desperately needs treatment alternatives. The recent of the approval of Omelizumab, which was the brand name Xolair pretreatment of food allergy in children and adults is a welcome addition. We see treatment for food allergy requiring a range of options just like other immunological conditions such as asthma, atopic dermatitis or inhalant allergies.

Speaker 3

And I'm asking you here to imagine, the position of a parent with a young child just diagnosed with peanut allergy at the pediatrician's office or the allergist's office until very recently stopped there. The only option available to concerned parents and caregivers was avoidance and diligent readiness with nipinephrine auto injector. Today is a different story and over time will keep on getting different and 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 and all the circumstances that surround the life of that child and that family. And that was another topic that we picked up in talking with KOLs and experts at AAAAI.

Speaker 3

Having a range of human options available only fuels that conversation. And for the 670,000 children in the U. S. Ages 1 through 7 currently living with a daily burn of a peanut allergy, every patient's story and situation is unique, requires a bespoke solution and that's what's needed here. Simply put, OneFias will not fit all.

Speaker 3

In an ever evolving market and we want to be very much part of that evolution, biosecantinib will always be a very important product. In fact, it will be, as the opinion of most, a foundational product as was evidenced after speaking with hundreds of allergists attending the AAAAI conference. Before I open up the call for questions, I would like to take a moment to share our anticipated milestones 2024, and this is a critical year for DBV. We anticipate initiating the first subject of our COMFORT TALERCE trial, the 6 month supplemental safety trial in support of a BLA. We also anticipate completing enrollment of our ongoing VITAS Phase 3 efficacy trial in children aged 4 through 7 years of age.

Speaker 3

And once VITAS enrollment is close to completion, we'll initiate recruitment for our 6 month COMFORT Children trial in support of that BLA. Recruitment, as Faris touched on, will be carefully timed, so as not to compete for the same study subjects across 2 different clinical trials. During the Q2, 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 3 year results from our ongoing Phase 3 open label extension of the Epitope trial later on this year.

Speaker 3

And finally, the publication in Science and Medical Affairs Machine at DBZ continues to be operating very actively. We anticipate publication of additional manuscripts, which includes publications as a result of the year 2 open label extension of Epitope, which Faris shared a few minutes ago, and additional in vital review with a peer reviewed scientific journal as well as submitting extracts of new results for presentation in upcoming conferences. So we'll keep on publishing a lot of data on our technology and its benefits. With that, we'll now ask Faris and Georgina to join me for the Q and A. And operator, if you could open up the line for questions, that'd be great.

Operator

We will now begin the question and answer session. Our first question comes from John Walden with Citizens JMP. Please go ahead.

Speaker 4

Hey, good afternoon and thanks for taking the questions. Sorry. But first, I was hoping you could give a little bit more color on this EU directive. And then also, can you comment how many of the 600 expected patients in BATISSE you've already enrolled to date?

Speaker 5

I'll have Faris answer the question on the directors. And then then Yes. Don, it's Farris. So this new EU directive is a little bit different from how things were done in the past. So you have to submit your dossier, your protocol and the countries that you've selected in Europe all are banded together essentially as one country.

Speaker 5

So in the past, you could go one off to Germany, Italy, Spain, whichever countries you wanted. In this case, they're all bundled into 1. So if any country has any objection, it has to go all the way to be resolved. And that process can continue almost indefinitely. And the big difference here is, if one country protests and has an issue, all of the countries are stuck.

Speaker 5

They can't participate and you can't pull out and one off go separately to all the first Phase 2 protocols that went through And so the system wasn't quite worked out. And I think there was just a glitch here and there. And as these new things come through, they're not always well oiled. So that's the nature of the difference in the directive now versus how it was in the past.

Speaker 4

Got it. And can you comment how many yes, can you comment on how many of the expected 600 patients have been enrolled so far?

Speaker 3

Yes. We don't provide that clarity of guidance for competitive reasons here. The study is progressing well against the forecast we had in place, assuming that these sites were up and running. 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.

Speaker 3

It took us closer to actually took exactly 9 months to go through it. And that explains why we are out of abundance of prudence pushing the expectation of last patient screen from first half of twenty twenty four to Q3 of 2024.

Speaker 4

Got it. Okay. And any time you guys on when Comfort Toddlers will be starting? And then how do you think about the parallel programs? Do you want them to be exactly parallel with BLA submissions in the same time period?

Speaker 4

Does that make it easier for you or potentially the review division? Or could there be staggering and one coming before the other?

Speaker 3

Yes. So, I'll have Farris answer the first question on comfort toddlers and I'll talk about the benefits of having the 2 programs being parallel here. Yes. John, as

Speaker 5

we've always said, we will start our Phase 3 programs when we have FDA feedback. So we're waiting for the FDA feedback. We've done all the preparations we can in terms of the team and the CRO being ready to roll once we get that feedback. So we believe it will be a short period turnaround from a clinopt standpoint. So again, I think it's the right thing to do for Phase III trials, get FDA feedback and alignment before we start to run.

Speaker 3

And we're in communication with them and they reinforce to us and we believe from the pace of no response, emails, everything else that they are, they say it's a top priority. We very much see that. But we're just waiting for that final sign off before starting the study out of, again, common sense prudence. And then I have the question. And then Mark?

Speaker 3

Yes, to come back to the benefits of the 2 doses in parallel, is that your other question? Yes.

Speaker 4

Yes, please.

Speaker 3

Look, both markets are used. So if it was essentially coming down to a raise to commercial potential, raise them even, quite simply. Obviously, the program in toddlers is more straightforward. There's only one study to run, while we have 2 to run with in 4 to 7 year olds. But that was why we were very happy when the agency agreed that these would be 2 separate BLAs, making not one to be junior to the other by being the BLA and the supplemental BLA.

Speaker 3

And thus, whichever one we can file first, we will file first, and making us, as a commercial matter, indifferent to which one is ready first.

Speaker 4

Okay. That makes sense. And then just yes, last one for me, Danielle. You touched on this, the Xolair approval. Can you discuss how allergists you speak to are thinking about Gliocene peanuts use versus Zolair use?

Speaker 4

Do you think there's 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 3

Yes. I'll have Saros give you more detail because he's we've all talked a bunch of allergists at AAAAI. But no, there's a very little overlap between the two markets, which is why Xolaira's approval is important here by offering options. The populations are pretty significantly different. So Faris, want to share what you've learned from that?

Speaker 5

Sure. So we spent quite a bit of time at AAAAI talking to our different sites. And the take home message we're getting from them is that Nolar has been approved a long time and it had been used off label with OIT in certain situations. And there hasn't been huge, huge off label use for peanut allergy as a standalone indication or even multiple food allergies. And the reason for our 1 to 7 year olds, the way we've been told is, especially in the toddlers 1 to 3, none of the investigators we spoke to would use it as sort of monotherapy for multiple food allergies or single food allergies because it's a toddler population.

Speaker 5

It's unknown what it would do for an immune system that is still evolving, very immature. And of course, it's an injectable. In the older patients, maybe 6 or 7, what we've heard was there could be extreme, extreme cases of patients that are ultra, ultra sensitive. So the anecdote that was told to me was a practitioner has a patient who could go to Chuck E. Cheese and this patient is so allergic to milk that any of the residual pizza cheese grease that's on there, and if they had touched their mouth or their eyes, they would go into an anaphylactic reaction.

Speaker 5

And this is just almost straight verbatim what this investigator told me. And for a case like that, where it's well documented that their sensitivity is just extreme and they've tried to avoid and done everything they can, that patient might be a candidate for omalizumab. But again, it's 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, 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 3

No, it's consistent with what

Speaker 4

we're hearing as well. So good to hear and thanks for the feedback and color guys.

Speaker 3

Yes. The formal market research also besides data with KOL shows, yes, to be used in older kids and adolescents or young adults or multi allergic at times in their life where you want to make sure that their behavior, whatever they're experiencing is covered. It's not the population that we wish to help with our product.

Operator

Our next question comes from Sushila Hernandez with Van Blanchet, Kempen. Please go ahead.

Speaker 2

Yes. Thank you for taking my question.

Operator

Could you just walk us through

Speaker 2

the steps ahead to get the BLA filing for the toddlers? And the second question, does your cash runway until the end of 2024 include the start of both safety studies? Thank you.

Speaker 3

Good question. So the answer to 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 of those two studies, the continuation of VITASP, a lot of work we're doing also when it comes to regulatory dose CMC and billing up inventory also. So there's a lot of our expenses this year are going to that. As far as next steps for the toddler dossier, sign off from the FDA on the protocol and then initiation of the trial.

Speaker 3

As far as that we've been in dialogue with many of the investigator sites, we can turn that around pretty quickly. What we don't know is how quickly the study will enroll. We know there's a lot of enthusiasm for that study. We know that food challenges, especially only one at entry in toddlers is easier to do, much easier to do than food challenges in older children. So we're confident this study will enroll at a good pace.

Speaker 3

But we have no analogs here. And for that reason, we're going to leave that as an open question until we have more data to guide more precisely to study completion in BLA filing. We expect also that once we have the clinical data to move to filing in BLA, we move rather quickly. The CMC work will be done by then. And it's not a complex dossier by the way, right, Seo.

Speaker 3

So it's pretty straightforward when it comes to the clinical data that we have to pull and analyze.

Operator

This concludes our question and answer session. I would like to turn the conference back over to Daniel Toussaint for any closing remarks.

Speaker 3

Covered a lot today, and thanks for those questions. So to recap, we're continuing to advance B. T. A. S, our Phase 3 study in peanut allergic children 4 to 7.

Speaker 3

In parallel, the successful completion of the supplemental comfort safety studies are important. And as I shared with our colleagues asking questions here, we have 2 BLAs that are distinct and in parallel, and thus one is not relating to the other one. And the moment we have sign off on the protocol in toddlers, we will initiate that study. It's well lined up. We are very confident or remain very confident this work will support BLAs in both age groups.

Speaker 3

And as we've picked up from dialogues with allergists at AAAAI, where we pick up when it comes to talking investigators, where we pick up in our market research. Families want treatment options. The more treatment options are available, the more dynamic the market will be and we all benefit from that. And this concludes the call for today. Again, we hope that we will keep on conveying success of our programs through 2023 to 2024 with laser focus on execution.

Speaker 3

And lastly, I want to apologize again profusely for a call that started later than expected. I thank you all. Wish you a good evening.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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