DBV Technologies (DBVT) has reported on the advancements of their Viaskin Peanut allergy treatment and financial outcomes for the full year of 2023 during their recent earnings call. The company discussed their clinical trials, including the Phase 3 trials planned for 2024, and provided updates on their Biologics License Application (BLA) submissions for different age groups.
Despite delays in initiating European clinical sites due to new regulations, DBV Technologies shared a positive outlook on their financial position, closing the year with $141 million in cash and an increase in operating expenses to support clinical development.
Key Takeaways
- DBV Technologies highlighted their successful product presentation at the American Academy of Allergy Asthma Immunology Annual Scientific Meeting.
- The company plans to enroll 1,400 children aged one to seven in Phase 3 trials of Viaskin Peanut in 2024.
- Viaskin Peanut has shown disease-modifying potential, allowing toddlers to consume more peanut protein without symptoms.
- The BLA submissions for the one to three-year-old and four to seven-year-old age groups are underway, with safety and efficacy studies progressing.
- Financials for 2023 ended strong, with $141 million in cash and a 25% increase in operating expenses for clinical development.
Company Outlook
- DBV Technologies intends to initiate a safety trial and complete enrollment for a Phase 3 efficacy trial for children aged four to seven in 2024.
- Plans for an Investor Day, trial results publications, and abstract submissions for conferences are in the pipeline.
- The company is focusing on providing personalized solutions and multiple treatment options for patients with peanut allergies.
Bearish Highlights
- The opening of European sites for clinical trials has been delayed due to a new European clinical trials directive.
- Uncertainties around study completion and BLA filing timelines for toddlers persist, with no analogs for comparison.
Bullish Highlights
- Continued improvement and treatment response observed in the second year of the EPITOPE study.
- The addition of Dr. Kevin Malobisky as Chief Operations Officer strengthens the company's leadership team.
- Positive reception and record-breaking attendance at a major scientific meeting indicate strong interest in Viaskin Peanut.
Misses
- Delay in screening completion for European clinical trials, expected to finish by Q3 of this year.
Q&A Highlights
- The company is awaiting FDA feedback on the COMFORT Toddler study protocol before initiation.
- DBV Technologies has a conservative financial forecast that includes the start of safety studies.
- The clinical data analysis and CMC work for the BLA filing for toddlers are expected to be straightforward.
In conclusion, DBV Technologies has demonstrated progress in the development of Viaskin Peanut, despite facing some regulatory delays. The company remains financially robust and is continuing to advance its clinical programs with a focus on addressing the needs of patients with peanut allergies.
InvestingPro Insights
As DBV Technologies (DBVT) continues to make strides in the development of their Viaskin Peanut allergy treatment, it is important to consider several financial metrics and analyst insights that could influence the company's trajectory. Here are key insights from InvestingPro:
- With a market capitalization of $144.46 million, DBVT is maintaining its position in the biotech industry, reflecting the market's current valuation of the company's potential despite recent challenges.
- Analysts are keeping an eye on DBVT's financial health, noting that the company holds more cash than debt on its balance sheet, a reassuring sign for investors concerned about the company's ability to fund ongoing clinical trials and operations.
- The company's revenue for the last twelve months as of Q3 2023 stood at $5.55 million, with a notable quarterly revenue growth of 14.37% in Q1 2023. This growth may align with analyst expectations of sales growth in the current year, providing a positive outlook for the company's financial performance.
InvestingPro Tips that could be particularly relevant for DBVT include the observation that the company is trading at a low revenue valuation multiple and that liquid assets exceed short-term obligations. These aspects suggest that the company is valued conservatively relative to its revenues and has a sufficient liquidity cushion, which might be appealing for investors looking for biotech stocks with a solid financial footing.
For those seeking a deeper dive into DBVT's financials and future prospects, there are additional InvestingPro Tips available at https://www.investing.com/pro/DBVT. These tips could offer valuable guidance, especially considering that analysts do not anticipate the company will be profitable this year and that the stock has experienced a significant decline over the last six months.
To gain access to these insights and more, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. Currently, there are 9 additional InvestingPro Tips listed, which could provide a comprehensive view of the company's financial health and market potential.
Full transcript - DBV Technologies (DBVT) Q4 2023:
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. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.
Katie Matthews: Thank you. And again our sincere apologies for the delay in starting today. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31st, 2023. This press release is available in the Press Releases 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 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. 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 the call today are Dr. Daniel Tassé, Chief Executive Officer of DBV; Dr. Pharis Mohideen, DBV's Chief Medical Officer; and Virginie Boucinha, our Chief Financial Officer. Before handing the call over to Daniel for those of you who may be new to DBV, we are developing Viaskin, an investigational proprietary technology platform with broad potential applications as an immunotherapy for the treatment of food allergies and other immunological disorders with Viaskin Peanut as our lead candidate. I will now pass the call over to Daniel. Daniel?
Daniel Tassé: Katie, thank you and thank you everyone. Again I need to add my apologies, we were in fixed confirmation that the K had 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 for having you on hold for 30 minutes. Today, we'll obviously give you an update on our progress when it comes to Viaskin Peanut programs and regulatory pathway and then Virginie will share with us the financial update. But before we do that, I'd like to share with you a few perspectives about Viaskin Peanut and the peanut allergy market, things that we have not discussed in a while. Starting the data, last week DBV attended the American Academy of Allergy Asthma Immunology Annual Scientific Meeting which was held in Washington D.C. The meeting which is known as AAAAI is regard as the premier events in the allergy immunology community and every year we have a lot of boots on the ground at AAAAI to listen, engage with our key stakeholders, allergists, and patient advocacy groups at very top of that list. One of the highlights of AAAAI this year was the fact that the product theater who's 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 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. There held 125 people, 223 allergists or more showed up. 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. We understand and we understand the huge responsibility we have of establishing the long-term safety and clinical benefits of Viaskin Peanut because treating children is an important responsibility. Our open-label extension commitment to patients, while it takes time and effort and financial resources ensures a rich population of subjects on Viaskin Peanut 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 two data from our open-label extension study in toddlers. And obviously, we cannot wait to see what the year three data will look like when we share it later on this year. In 2024, we will continue to work towards stream a robust data package in toddlers and children. 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. All our Phase IIb studies have an open label extension, which as I mentioned just now is key understanding long-term treatments 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 allergy is going to be a massive safety database for our one to seven year olds who have in fact close to 1,700 subjects on active treatment. And we combine that with the data from our prior Phase two trials. We break this down with approximately 600 toddler patients, 600 toddlers age one to three and about 1,100 patients age four to seven. We'll have been on immunotherapy for up to three years. And let's not forget all the work we've done in four to 11 before that, where some of those children were treated with Viaskin Peanut for up to five years. And that's and that data was shared at quite a high last weekend. To sum it all up and put this in perspective, over one million Viaskin patches have been applied to children age one through 11 in our clinical development program. That's obviously more than one million days of therapy that makes up the safety database of this product's, safety and efficacy database as described. And it is as I said the most comprehensive research in children with peanut allergy. We have a well-studied product, with demonstrated 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 Viaskin Peanut' 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 two of our ongoing open-label study extension study. Data showed that approximately three out of five toddlers could consume almost 3.5 grams of peanut protein without triggering stopping symptoms during the food challenge. 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 eliciting dose at baseline of 100 milligrams. 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. We also have two other data sets from prior studies, showing that Viaskin Peanut can induce, what is known as sustained unresponsiveness to the allergen in older children, who after two to three years of treatment, 8% of participants maintained desensitization of Amylin 1000 milligrams or more at two months after stopping treatment. And thirdly, we know from our studies in animal models that the data suggests the Viaskin Peanut induces sustained unresponsiveness of the Allergan (NYSE:AGN) by modulating the epigenetic signature a specific T-cell compartments. Remember Viaskin Peanut has a unique mode of action that leverages skin's in properties induce tolerance and there's no other product. I would add there that shows that mode of action. With all this in mind while this is not been the case we'll be pursuing at approvals, we fully intend post-approval. And as part of our long-term commitment to these sooner exploring Viaskin 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 Pharis, our Chief Medical Officer for a detailed update on our two best Internet programs.
Pharis Mohideen: Thank you, Daniel. As a reminder, we intend to submit two separate BLAs for the treatment of peanut allergy. In the one to three 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. 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. To be clear, the FDA was not looking for a specific safety signal or a specific safety concern. We call this six month safety study COMFORT Toddlers. In parallel, we are running the four to seven year old indication with the modified circular patch. We started this program last year with a 12 month PEPITES study. Recruitment is ongoing at this time. This indication will also have a six month supplemental safety study, which we call COMFORT Children. The two 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 the test and starting our two supplemental safety studies. As Daniel mentioned, DBV T has always been committed to generating the most robust data set possible in our clinical trials. The test is no exception. We recently submitted an amendment to extend the open label phase so that every subject enrolled in the trial has the opportunity to receive Viaskin Peanut for up to three years. And remember, we also have our expanded access program for subjects that have completed in treatment in a DBV clinical trial. And once you continue to receive Viaskin Peanut. So that test is set up to provide another large robust dataset 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 four to seven year old age group, where we believe Viaskin Peanut can provide great clinical benefit. In the test we have 86 clinical centers spread across the US, 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. That brings me to the COMFORT Children supplemental safety study in four to seven year olds. 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 product and 12 months of treatment for subjects randomized to placebo. Every subjects will have the opportunity to receive Viaskin Peanut for a full year. This will be a 270 subjects study randomized three to one active to placebo. The main inclusion criteria will be based on skin prick test and peanut-specific IgE levels. These criteria are sufficient to ensure a similar patient population relative to the tests. Thus, there is no need for a food challenge, as part of the inclusion criteria. One of the differences in COMFORT Children relative to the tests, is the use of a simplified instructions for use. The safety study IFU states each DBV’s 712 -microgram epi-cutaneous system is intended to be worn 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. This new IFU, more accurately reflects allergen immunotherapy and how we expect our product to be enabled, if approved. Based on a past similar safety study, we conducted in four to 11 year olds, we believe COMFORT Children would be on attractive study, with potential subjects and at research centers. 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. Okay. Let's move to the top of the program. The results from the first 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 Viaskin Peanut for up to three years. For subjects or originally randomized to active treatment, we have data for two years on treatment and for those randomized to placebo, we have the one-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. 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. Using the Responder criteria and EPITOPE, the response rate increased from 67% to almost 84% and four out of five subjects, 81% consumed an eliciting dose of greater than or equal to 1000 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. We believe these are really impressive results that continue to build upon our extensive and robust Viaskin Peanut clinical dataset. 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 Viaskin Peanut. No subjects had treatment-related serious, treatment-emergent adverse events during the 2nd year of treatment, with Viaskin Peanut and no treatment related permanent study discontinuations occurred. Furthermore, there were no treatment related anaphylactic events, during the 2nd year of treatment with Viaskin Peanut. Remember, our studies used a very broad definition of anaphylaxis, principally 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 crossover efficacy and safety appeared to be virtually identical to the first 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 of three year olds and EPITOPE that crossed over as four year olds in the Open-Label extension some had a robust treatment effect. This bodes well for the VITESSE study. Let me wrap-up with the toddler, COMFORT Toddler study. This is a six month study that will include 400 subjects randomized three to one active to placebo. Like the COMFORT Children study, subjects will have the opportunity to receive active treatment for up to one 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. 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 as EPITOPE as possible. 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. 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. With that, we'll now ask Pharis and Virginie to join me for the Q&A. And operator if you could open up the lines for questions, that'd be great.
Operator: We will now begin the question-and-answer session. [Operator Instructions] Jon Wolleben with Citizens JMP. Please go ahead.
Jon Wolleben: Hey, good afternoon and thanks for taking the questions. First, I was hoping you can give a little bit more color on this EU directive. And then also can you comment how many of the 600 expected patients in VITESSE you’ve already enrolled to-date?
Daniel Tassé: I'll have Pharis answer the question on the directive.
Pharis Mohideen: Yeah, Jon, it’s Pharis. So this 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. So in the past you could go one off to Germany, Italy, Spain, whichever countries you want to, in this case they're 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. And the big difference here is if one country protests and has an issue all of the countries are stuck, they can't participate and you can't pull out and won off, bill separately to all the different countries. So it is a bit different and I think the challenge here was we were one of the first Phase 2 protocols that went through. And so the system wasn't quite worked out, and I think there was a 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.
Jon Wolleben: Got it. And can you comment on how many of the expected 600 patients have been enrolled so far?
Pharis Mohideen: 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 the sales were up and running, we've been up and running there as expected. What I can share is we expect that 60 to 90 days would be sufficient to get through the new directive process. It took us closer to -- actually took exactly nine months to go through it. And that explains why we are out of abundance of prudence pushing the expectation of last patient screen from a first half of -- Q2 of 2024 to Q3 of 2024.
Jon Wolleben: Got it. Okay. And any timing guidance 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? Does that make it easier for you or potentially the review division? Or could there be staggering and one coming before the other?
Daniel Tassé: Yeah. So I'll have Pharis answer the first question on COMFORT Toddlers, and I'll talk about the benefits of having the two programs being parallel with.
Pharis Mohideen: Yeah. Jon as 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 [indiscernible] being ready to go once we get that feedback. So we believe it will be a short period turnaround from a financial standpoint. So again and it's the right thing to do for Phase 3 trials get FDA feedback in alignment before we start to run.
Daniel Tassé: And we're in communication with them and they may reinforce to us. And we believe from the pace of no response e-mails everything else that they are -- this is 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.
Jon Wolleben: And then the other question?
Daniel Tassé: Yeah to come back to the benefits of the two doses in parallel, is that your other question?
Jon Wolleben: Yes, yes please.
Daniel Tassé: Look, both markets are use. So I think it was essentially coming down to a rate to commercial potential, rate them even, quite simply. Obviously the program in toddlers is more straightforward is only one study to run. What we have to run with in four to seven year olds. But that was why we were very happy when the agency agreed, that these would be two separate BLAs. Making not one to be junior to the other by being the BLA and the supplemental BLA and thus, whichever one can file first. We will file first and making us as a Commercial matter in different two which one is ready first.
Jon Wolleben: Okay. And then, just to …
Daniel Tassé: That makes sense?
Jon Wolleben: Yeah. Last -- last one for me Daniel. I know you touched on this, but product approval. Can you discuss how allergist you speak to or thinking about Viaskin Peanut to use versus older used EPITOPE. 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 the product profile? And I'll jump back in the queue. Thanks.
Daniel Tassé: Yeah. I'll have Pharis to give you more detail, because the stuff, we've also talked a bunch about or just acquired. I know there's very little overlap between the two markets which is why, as all their approval is important here by offering options. And the populations are pretty significantly different. So Pharis will share the, which is done from it.
Pharis Mohideen: Sure. So we spent quite a bit of time quite talking to our different sites. And the take-home message we're getting from them is that, lower had been approved a long time and it has 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 you know for our one to seven year olds the way we've been told is, especially in the toddlers one to three, 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. It's unknown what it would do for a immune system that is still evolving very immature. And of course, it's an injectable. In the older patients' maybe six or seven, 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 practitioner has a patient who could go to Chuck E. Cheese: and especially so allergic to mount that any of the residual Pizza Cheese Greece that's on there. And if they have touch them after their eyes they would go into an anaphylactic reaction. And this is just almost straight verbatim what this investigator told me and for a case like that where it's well documented, that the 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?
Jon Wolleben: No it's consistent with what we're hearing as well.
Pharis Mohideen: Yeah.
Jon Wolleben: So good to hear and thank you for the feedback and color guys.
Daniel Tassé: Sure. The formal market research also besides data with KOL shows. Yeah. It could 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 or whatever they're experiencing is covered. It's not the population that we wish to help with our product.
Operator: [Operator Instructions]
Pharis Mohideen: Next question operator.
Operator: [Operator Instructions ]Our next question comes from Sushila Hernandez with Van Lanschot Kempen. Please go ahead.
Sushila Hernandez: Yes. Thank you for taking my question. Could you just walk us through the steps ahead to get to the BLA filing for the Toddlers? And the second question does your cash runway until the end of Phase 4 includes the start of both safety studies? Thank you.
Daniel Tassé: Good question. So the answer is the same for 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, a continuation of the test, a lot of work we do and also when it comes to regulatory dossiers, CSA, CMC, and building up inventory also. So, there's a lot of our expenses this year are going to that. As far as next steps for toddler dossier, sign-off from the FDA on the protocol and then initiation of the trial. As Pharis said 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 this study will enroll. We know there's a lot of enthusiasm for that study. We know that food challenges, especially, one that 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. And 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 BLA filing. We expect also that once we have the clinical data to move to filing a BLA, we'll move rather quickly. The CMC work will be done by then and it's not a complex dose here by the way right here. So, it's pretty straightforward. It comes to the clinical data that we have to fully analyze. Answering your questions, Sushila?
Sushila Hernandez: Yes. Thank you.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Daniel Tassé for any closing remarks.
Daniel Tassé: Covered a lot today and thanks for those questions. So, to recap we're continuing to advance VITESSE, our Phase 3 study in peanut allergy children four to seven. 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 two BLAs are distinct in parallel and thus one is not relating to the other one at the moment we have sign off on the protocol in toddlers, we will initiate that study as well lined up. 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. And this concludes the call for today. Again, we hope that we will keep on conveying the success of our programs to 2023 and 2024. We're laser-focused on execution. 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.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.