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spk10: Hello, and welcome to the Ascendus Pharma third quarter 2023 earnings conference call and webcast. Following the prepared remarks, there will be a question and answer period. Instructions will be given at that time. I would now like to hand the conference over to Tim Lee, Senior Director, Investor Relations, Ascendus Pharma. Senator, you may begin.
spk07: Thank you, Operator, and thank you, everyone, for joining our third quarter 2023 financial results conference call. I'm Tim Lee, Senior Director of Investor Relations at Ascendus Pharma. Joining me on the call today is Jen Mickelson, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, and Dr. Sina Singhal, Executive Vice President and Head of Clinical Development Oncology. Before we begin, I'd like to remind you that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements may include but are not limited to statements regarding our commercialization and continued development of Skytrofa for the U.S. and European markets, as well as our expectations for 2023 Skytrofa revenue, the expected timing of the approval and launch of Transcon PTH in the U.S. and the EU, our pipeline candidates and our expectations with respect to their continued progress and potential commercialization, our strategic plans, our goals regarding our clinical pipeline, including the timing of clinical results, our ongoing and planned regulatory filings, our expectations regarding the timing and the results of regulatory decisions, our expansion into new therapeutic areas, our progress toward Vision 3x3, and our ability to become cash flow positive and create a sustainable, profitable, and leading global pharma company. These statements are based on information that is available to us today. Actual results and events can differ materially from those in our forward-looking statements, and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that can cause actual results to differ materially, please see our forward-looking statement section in today's Today's press release in the risk factors section of our most recent annual report on Form 20F filed February 16, 2023. Pranscon Growth Hormone, or Pranscon HGH, is approved in the U.S. by FDA, and the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. Otherwise, please note that our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of the product candidates have not been reviewed or approved by any regulatory agency. None of the statements during the conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our third quarter 2023 financial results and we'll provide further business updates. Follow us in prepared remarks. We'll then open up the call for questions. And with that, let me hand it over again.
spk03: Thanks, Tim. Good afternoon, everyone. Our dedication to the values of patients' science and passion remains the foundation for incentives to create long-term value for all stakeholders. In the U.S., we achieved market value leadership for SkyTofa within two years by sticking to our belief that a premium product deserves a premium price. Following the same strategy in Germany, we launched SCOT-HOFA in September and also expect to also launch Transcom PTAs in January 2024, if approved by the European Commission in November. In select other European countries, we will use the same direct sales model to launch our portfolio as we have in the US and Germany. We call this EU Direct. In other markets, we will commercialize our portfolio to sales and distribution partners who are local experts in their diseases. We refer to this as international indirect markets. In Japan, we intend to partner our endocrinology rare disease products. We believe we have the organization and the manufacturing capacity to support expected launches of three independent endocrinology rare disease products by 2025. Driving further growth, we aim to continue to work to create highly differentiated transplant product candidates. expanding into additional endocrinology rare disease indication. Last quarter, we announced the expansion of our Transcon platform, a new type of carrier platform, specific designed to support new product opportunities in diseases with large patient population. I look forward to share more information with you about this in the near future. Let me provide more details on each of our programs. For Transcom Go to Moon, commercialized at Skatoka, we reported strong revenue growth, finished the third quarter with 47 million euros, including initial revenue from Germany. We now expect full-year 2023 Skytofa revenue to be between 170 and 175 million euros. To drive differentiation and market leadership, we continue to build on the science and data behind Skytofa. We recently announced results from our long-term extension trial showing that the majority of patients treated with transplant dopamine met or exceeded average parental height SDS at the time of their treatment completion or last visit. The data also demonstrated the long-term safety of SCARTOSA in patients treated after six years. In adult growth hormone deficiencies, we expect to see a top-line result during the fourth quarter from our global phase 3 foresight trial. Today, we estimate less than 4% of adult patients suspected of having growth hormone deficiency are treated with growth hormone, making this an opportunity to both expand SkyTofit's label and expand the overall growth hormone market. In addition, We plan to launch SCOTOFA in certain markets in our international indirect region with initial revenue contribution expected to begin in 2024. Turning to Transcontinental PTAs. In the European Union, EMEA CHMP adopted a positive opinion in September. recommending approval of Transcon PTAs as a replacement therapy for adults with chronic hyperparathyroidism. We expect the European Commission final decision on our marketing authorization application this month. If approved, we plan to launch Transcon PTAs in Germany in January 2024. In Germany alone, where the annual cost for currently approved PTH treatment is around 77,000 euros per patient. Our target population is 22,000 chronic hyperparalyzed patients, out of the overall patient population of around 17,000 patients. Our staff is team in Germany that launch SCAR-TROPHE is ready to launch transplant PTH if approved. And EU approval will also provide the basis for marketing authorization and initiation of commercial activities for Transcon PTH in additional markets in our internal market segment, where we expect to launch starting in 2024. And further launches in Europe direct in 2025, following standard price and reimbursement pathways. By following our algorithm for product innovation, we will have taken Transcon PTH from IDEA to expected regulatory approval all in about seven years. In the U.S., all documents have been finalized, and we expect to resubmit the NDA for Transcon PTH for adult with hyperparathyroidism within a week. We expect to know where the FDA has accepted our resubmitted MDA with 30 days from the resubmission date. If accepted, we expect the FDA to notify us at the time where the resubmission is class one or class two, and provide a new PDUFA date. Besides this information, we will not comment further on the resubmission. As with Geithhofer, We continue to build up the science and data behind Transcon PTAs. In September, we announced a post-hoc analysis of Phase 2 and Phase 3 data, demonstrating substantial increase in estimated GFR in adults with hyperpyothyroidism treated with Transcon PTA. These data suggest that treatment with Transcon PTA can reverse impaired kidney function in patients with hyperparathyroidism. Turning to Transcon CMP, this is our third endocrine rare disease product candidate. Following our End of Phase II meeting with U.S. and EU regulatory agencies, we have lined on the pathway to potentially receive regulatory approvals in the U.S. and EU. We expect top-line results from our purist phase 3 approach trial with completed enrollment in Q3 in the second half of 2024. We continue to have strong patient retention in our trials, and during the fourth quarter, we will provide an update and share with you one-year follow-up data with the open label extension portion of ACCOMPLISH. We believe the strong retention in our clinical trial is a result of additional benefit of transplant CLP in addition to height improvements. as we have further evaluated the science behind achondroplasia and our own data. We now believe that achondroplasia is a disease of both skeletal growth and muscle function, and that the continuous exposure to the CMP enabled by Transcon-CMP may be able to address both elements. Coming update, we will disclose these additional potential benefits of Transcon-CMP in addition to height. If we are right, that is correct that achondroplasia is a disease of both skeletal growth and muscle function. This means that Transcon-CMP could potentially offer value for adults living with achondroplasia. who experience muscle fatigue or other medical and quality of life impacts that may be potentially addressable with constant exposure to CMP. We are in a constructive dialogue with regulators on how best to evaluate the potential impact on transplant CMP on comorbidities. quality of life, and other important aspects of achondroplasia, in addition to height, to support an indication for treatment of achondroplasia. While our key focus in the treatment of achondroplasia is to address the comorbidities that are associated with this disease, we believe an even more effective way to address height, if needed or desired, could be CMP in combination with Gotamo. We believe that this combination therapy may provide greater analyzed height velocity and CMP alone, and at the same time address the comorbidity of acromioplasia. Our previously presented preclinical data demonstrate the additive effect of combining transcom-CMP and growth hormone in animal models. assisting with stimulation of different growth-promoting signal pathways in the growth plate. Supporting this idea, a group out of Osaka University in Japan presented a poster during last month's ASBMR, showing that a large group of 41 agronomical children treated with growth hormone demonstrated first-year analyzed high velocity of around 7.4 cm with sustained growth benefit through five years of treatment. To explore this concept, we plan to submit an IMD amendment or similar to initiate a combination trial of Transcon-CMP and Skytroper by the end of this year. Moving to Oncology. For Transcon IL-2 Beta Gamma, we recently reported new data from the, I believe, trial of Transcon IL-2 Beta Gamma as monotherapy and in combination with Tempro at ESMO. These data confirmed that Transcon IL-2 Beta Gamma dose every three weeks demonstrated clinical activity as monotherapy or combination therapy, of course, late-line heavily pre-treated patients in multiple tumor types. further strengthening our confidence in its best-in-class potential. In two out of three small lung cancer patients treated with combination therapy in the trial, a confirmed partial response and unconfirmed complete response in the first tumor assessment of an ongoing patient were observed. We believe these data are intriguing, despite the very small sample size, considering the treatment history of the responders and the substantial unmet medical need. Enrollment is ongoing in the indication-specific cohort of AIP, I believe, where we are now enrolling 20 to 40 patients in each indication, and we expect interim results in the second half of 2024. In summary, with growing revenue, maturing of our pipeline, we continue to progress to our goal of becoming profitable. With our vision 3x3 on track to be achieved in 2025, we are preparing for our next vision for growth to 2030. In our next vision, which I look forward to sharing with you at the beginning of 2024, We will work to level our fully integrated capability to become the leading endocrinology rare disease company, taking product from concept out to patient on a global scale with a highly productive organization. In other areas where we believe Transcom can deliver best-in-class product candidates, as we have in oncology and ophthalmology, we plan to pursue partnerships over business models to take out our product candidates to late-stage development to commercialization. Such future partnerships in oncology and ophthalmology, along with the maturation of our endocrinology program, should result in lower expenses in the coming years. By staying focused on achieving valued market leadership globally for our endocrinology rare disease portfolio, we believe Ascendant will deliver sustainable value over the long term for patients, shareholders, and society. I will now turn to call over to Scott for a financial review before we open for questions.
spk08: Thank you, Jan. As Yen noted, we believe we are making significant progress towards our goal of becoming cash flow positive, with Skytrofa revenue growing each quarter combined with diligent expense control. I will touch on some key points surrounding our financial results, but for further details, please refer to our Form 6-K filed today. Total revenue for the third quarter of 2023 was €48 million. Skytrofa revenue for the third quarter was €47 million, compared to €35.9 million reported in the second quarter and €12.3 million reported in the same period last year. The sequential growth in Skytrofa revenue was primarily driven by increased demand in the U.S., with minimal foreign currency impact of around €100,000. Exiting the third quarter, we estimate we have low double digit penetration into the U.S. pediatric GHD patient population. And we see a large opportunity in front of us to grow our patient share in pediatric GHD, which we estimate to be only half of the addressable U.S. growth hormone market. Turning to expenses. R&D costs in the third quarter totaled €111.4 million, up 6% sequentially from the second quarter of 2023, primarily driven by higher endocrine rare disease-related costs, including clinical expansion and PPQ manufacturing costs related to TransConCNP, partially offset by lower oncology-related costs. SG&A expenses declined 9% sequentially to 63.6 million Euro compared to the second quarter of 2023, primarily related to lower commercial and G&A external costs. Total operating expenses were 175 million Euro for the third quarter, flat sequentially from the second quarter of 2023. Overall, our operating loss declined sequentially by 5% to €134 million for the third quarter from €141 million in the second quarter of 2023. We ended the third quarter with cash, cash equivalents, and marketable securities totaling €455 million, including proceeds from the previously announced $150 million royalty funding agreement. Looking ahead, with continued momentum for Skytropha in the U.S., we are increasing full-year 2023 Skytropha revenue expectations to 170 million to 175 million euro. Let me now also provide a review of selected key program milestones. For TransCon Growth Hormone, we expect to report top-line data from the Global Phase III Foresight Trial in adult GHD in December. potentially opening an opportunity to both expand Skytropa's label as well as expand the overall growth hormone market. For TransCon PTH, as Yen noted, we are on track to resubmit our NDA for TransCon PTH for adults with hypoparathyroidism before mid-November. We expect a European Commission decision on TransCon PTH this month. If approved, we plan Transcon PTH is our second product launch in Germany, starting in January 2024. For Transcon CNP, we expect to submit an IND amendment or similar for a new clinical trial evaluating Transcon CNP in combination with Transcon growth hormone in children with achondroplasia. We plan to share follow-up data from the open-label extension of our Phase II ACCOMPLISH trial later this quarter. And as a reminder, We expect to report top line results from APPROACH, our phase three trial of Transcon-CNP, in the second half of 2024. Within our oncology therapeutic area, enrollment continues in the phase two portion of our AL-BELIEVE trial of Transcon IL-2 Beta Gamma in indication-specific cohorts. We expect initial data from indication-specific cohorts in the second half of 2024. With that, operator, we are now ready to take questions.
spk10: At this time, if you would like to ask a question, please press star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. We do ask that you limit yourself to one question and one follow-up. We will pause for a moment to allow questions to queue. Once again, that is star 1 to ask a question. Our first question comes from Jessica Fly with JP Morgan. Your line is open. Please go ahead.
spk09: Hey, guys. This is Nick on for Jess. Thanks for taking our questions. Can you talk to us a bit more around your strategy with the oncology and ophthalmology programs and kind of what that means in terms of OPEX, both over the near term and maybe more so over the long term and how that could change?
spk03: Thanks, Nick. The question related to What do we do as a company with a very, very strong platform technology that basically has application in nearly every therapeutic area? We at SENDIS will be focused on rare disease endocrinology. This is where we will be integrated from idea state out to the patient. It's where we're building up all the effort. We also know that the transplant technology would provide paradigm shift product, best-in-class product outside our own focus area. And we also feel that we need really to be part of that valuation also to the benefit of the patients. We will have different business models that will fit exactly to each single therapeutics Some errors we will basically outline on an early stage where the feeling is that it's the optimal thing. It could potentially be last patient indications where we basically never can succeed with running all the big clinical trials. It could be errors like ophthalmology where we mature it to a stage and then we potentially give it out either to a spin-out or an outlining or a combination of both, where we feel that an independent management team really with a focus on, for example, ophthalmology, really, really can mature it. It's not the same thing as Centisnot where we continually be involved. We will still provide service to this entity. We will be part of the upside, both related to royalties, milestone payment, and equity. In other areas like oncology, where we feel that we really can make a huge difference on the patient, we make an investment in it, and we will continue to make an investment into it until we feel that we can get the full value on this. And when I see how we're progressing with this oncology effort, I'm really, really proud about it.
spk09: Okay, great. And maybe, can you help set the stage for the update from the Phase 2 accomplished trial and what you hope to see when you have all the patients on the 100-microgram for the full year?
spk03: Yeah. What we hope to do that we will provide you with the element that we really believe is essential for the patients. We will provide you with the sustainability of how we keep the positive benefit on growth, but we will also come in and try to give you the explanation, both from a scientific base, but also through data, how we feel that we are providing a benefit to the treatment besides just providing them analyzed height velocity. We are 100% in the belief that the key element for us is to address the co-morbidities associated with this disease, and that is our focus on that. And this is why we believe that analyzed height velocity is an element, if it's desired, and if the patient really wants to have it, That can always go into perhaps the most powerful combination of treatment is CMP to move the brake growth hormone to speed up the accelerator, and you basically will have what we call the wanted desire analyzed high velocity compared to the patient's need and desire.
spk10: The next question comes from Paul Choi with Goldman Sachs. Please go ahead.
spk06: Good afternoon, and thank you for taking our questions. My first question is just with regard to Transcom PTH positioning in the major European markets, specifically Germany, and just how you think positioning will be, particularly given surgical complication rates there, and then just the pace of reimbursement access. And then I had a follow-up question.
spk03: You're right. The European and the international market, as we call it, is what we call much more diverse way of reimbursement. The fastest one is Germany, where already from January, where we expect to launch Planscom PSA, will be fully reimbursed. The patient population in Germany is actually pretty large compared to the size of the country, mainly driven by an higher treatment on head and neck operation. So you're right, it's a post-circular patient that is much higher. And we believe the addressable element of patient, not the total patient population, is about 22,000. At the same time, we are in a position where the only approved treatment for hyperpara in Germany is being taken away from the market. So we are in an intensive discussion with all the key centers how we really can help more than the 400 patients that basically already are established on the PTH treatment, how to take them on treatment in 24. Besides that, for many years, there has been a long, long layout of patients that want to be on a PTH treatment but never have the opportunity to do it. And this is why the European approval gives us a fingerprint, starting immediately on a full-blown commercial effort in Germany, at the same time a European approval. or EC approval give us the opportunity to go to a named patient program and addressing more than the 400 plus MAPAR patients that still is in other European countries which we feel a huge responsibility for also helping and also the patient that didn't come into any treatment in the last many years. Rest of EU will take 12 to 24 months to be fully reimbursed fully running commercial perspective at the same time then eu approval which we expect to get here in the coming week will provide us with an approval system for addressing patients in the international market. Some market we will have an independent application, other market we can directly refer into our European application. So we are dedicated really to help patients everywhere in the world which have a need for the treatment because of the hyperparapatient situation that exists today.
spk06: Okay, great. Thank you for that. And just as a quick follow-up, with competing HGH products approved here in the U.S., can you maybe just comment on maybe what mix of formulary access might be up for renegotiation this year and any general comments you've had into the 2024 renegotiation period? Thank you.
spk03: I've been asked in the last three, four months a lot. what is really the impact on having two other long-acting products in the U.S. market. And clearly, clearly, we never have seen more interest. We have not seen better numbers ever since it got clear which really best-in-class property Skytober has compared to the other products. Really building up on what we have established in the last two years, how we really are changing the treatment regime in treatment of pediatric growth hormone deficient with a better outcome. And that is not going to change with any other long-acting. Basic is just providing, I believe, for some of them and lower far to exceed and overcome compared to, for example, medical exceptions.
spk10: The next question comes from Joseph Schwartz with Lee Ring Partners. Please go ahead.
spk07: Thanks so much. So a couple questions on TransCon C&P, if I could. First of all, I was intrigued by your commentary about chondroplasia being not only a bone disease but having a muscle component, and I was curious if you could just talk a bit about how you intend to illustrate the benefit of TransconCNP on those aspects of the disease, and then also in terms of TransconCNP's potential to be combined with TransCon or Skytropha, rather, as it's now called. I was wondering, given I thought a lot of the earlier science suggested that growth hormone supplementation in achondroplasia had just an ephemeral benefit, you know, what are your thoughts on the potential for the combination to show a more sustained response in achondroplasia?
spk03: Thanks for the question. Let me start with your last question about the analyzed high velocity. We always have known that proptamone had a positive effect on aconiplasia. Sometimes it has been a little bit unclear what has been the magnitude on that because it typically have been small trials When we saw the trial coming up from the Japanese group, pretty well controlled, following patient up to five years The number is nice, 41. Everything looks great. They have one year before treatment, follow on what is the analyzed high velocity before treatment, and it's about 4.2, exactly what you will expect to see out from this kind of demographic. And the first year, analyzed high velocity up on 7.3, 7.4. That is more than I've seen any kind of CMP treatment ever give it. And when you have 41 patients, I always feel that it's a number that gives me some pretty good comfort. And it's the best analyzed height velocity I have ever seen in any height trial with a contemplative patient. We went back and analyzed 20 publications about all small trials, some of them, all of them. And you know, if we are being smart, really have gone to the literature in depth, then we We couldn't actually have seen it, because out from this 20 publications, we nearly got the same number when we added everyone up. So this is not surprising. It's something that has been in the literature, has potentially been understated, undervalued. But there is no doubt, the best analyzed high velocity you can get in air contemplation today is on growth hormone. The problem with that is, would it really address comorbidities? I don't believe that. I believe that the biology behind the achondroplasia is a much more complicated biological impact on a hyperactive FDR3 receptor. And there it comes in because in the end, We are just starting the beginning of the beginning of acondiplasia treatment. We are not in the end of the beginning even. We are in the beginning of the beginning because we need to address the co-morbidities. So this is why we believe the treatment is potentially moving to a combination treatment where CMP will address some of the biological systems where we believe acondiplasia or the hyperactive FDR3 pathway are modifying and disease that basic are also of the muscle growth impact. And you ask me, why did we see that? It was basically the patients, the parents, the caregivers that came back to us. We got in the patient reported outcome. We can see after one or two months, the patient are providing much better. function much better. And we said, it cannot be growth. It cannot be growth. And then we started to analyze this. And we realized that is a strong muscle component of that. And what we would like to do when we have our CMP update, we will give you the biology behind it, explain why we do that. And also, we believe that it's important for us to provide you data with the combination therapy, because I believe in the combination therapy, you can get whatever analyzed high-velocity, potentially the same as you can see in growth hormone deficient, up to 10, 12 centimeters.
spk10: The next question comes from Yaron Werber with TD Cowan. Please go ahead.
spk04: Great. Thanks for taking my question. Maybe one very quick one, and the second one is a little bit bigger. Just on the PPH, the refiling is going to be sort of in the next week or so. Can you just comment, did you sort of by this point work out all the analysis that FDA is going to want you to do, or do you feel like you have good clarity? And then secondly, on the preclinical GLIF-1, You know, the data with SEMA obviously looked interesting on a monthly basis. What are sort of the next steps as you see them before you can start INV-enabling studies? Is it you're still trying to fine-tune the construct, or is it potentially trying to figure out is this something you want to take yourself, or is it something that you want to ultimately potentially partner? Thank you.
spk07: Hey, Yaron. This is Tim. Let me take the first part. As Yen noted on his prepared remarks, Besides the information that we just discussed, we're not going to comment further on the resubmission process.
spk03: Okay. Related to the DPL-1, We are in a great state. We came out with the data. It provided the interest that people could see the value in it, both as an improved one-weekly treatment, but also on a once-monthly treatment for this important segment growing up. And we basically continued the dialogue with companies that are interested in that area.
spk10: The next question comes from Lee Watzik with Cancer Fitzgerald. Please go ahead.
spk01: Thank you for taking the questions. Just first one, we've seen, you know, daily products continue to retreat and reduce output in Q3. Can you just talk about how much of a tailwind that has been for Sky Shofa, and where do you see that trend to track in the coming quarters?
spk03: The question you are addressing, what is really happening in the growth hormone market? And I think what we are seeing is the results of the consolidation that we have predicted, had expected to happen. And that is basically what you see in the marketplace today. For years ago, when we came up with our Phase 2 data and we didn't outline our Transcon growth hormone, a lot of these established players basically said, okay, let us find out how we can milk this here in the best possible way. And you don't milk by investing in production capacity. You don't really get the highest property to investing in anything. So this is why you're seeing a daily growth hormone market basically only have three players left now with a sales force, infrastructure, and other things like that. So instead of having six players, you're down to three players, and likely there will be fewer players in the coming year when the really the real consolidation will happen. So some way you're saying is there is a shortage, but the shortage is also indicated in the way that the consolidation of the market promoted a shortage of it. Because if it were old days with many more companies really could provide more capacity on other things, there would not have been a shortage. It's not changing the fact. It's not changing the fact why Skytrofa is the leading company, leading brand in value is because we're providing best-in-class properties. And it's getting realized by physician, by caregivers, by patients, and I hope and we know that also by the reimbursement system.
spk01: Okay. And then maybe just a question on TRNSCON L2. You showed some pretty nice data in small cell lung cancer. So is there any plan to add this indication to our expansion cohort?
spk02: That's a great question, Lee. Yeah, we were very encouraged by our initial signal in small cell lung cancer, and we are exploring adding additional indication cohort in lung cancer to our those expansion goals. Great.
spk10: The next question comes from Leland Gershel with Oppenheimer. Please go ahead.
spk05: Hey, thanks for taking my question. Just wanted to ask further on the plans to explore transclin CNP for benefit outside of high velocity in terms of other comorbidities. Wondering, Anne, if you could just maybe go into maybe beyond muscle Are there other measures or endpoints that you're contemplating to include in upcoming studies? Thank you.
spk03: We are exploring a lot of different elements. I would like to group it a little bit. One is the patient-reported outcome, where you have both our own developed way to look at it. You have established one as SF10 and other ways that really are capturing how you potentially have a physical benefit of this treatment or not. So this is one what we call the patient-reported outcome. The other one we're looking for is dedicated comorbidities. Are there clear pattern where we see less comorbidity over a year period because you need to go through some season to be quite sure you're picking up what kind of element of cold or other thing could influence it. The other one is more hardcore element where we basically have a lot of x-rays of the patient Are they really changing the scolitis? Are they changing other elements? And we're looking on all different kind of bone development and other things like that. This is in the older children. When we go to the newborn, we started now, we go for much more hardcore facts, how to, for example, benefit in spinosis. Do we see the same? element of fast fusion of the synchronized or other things like that. And I think this is where we take the different age group, finding out what can we really do with that. And that is what we're analyzing and building into our pivotal phase three trial now. So we're quite sure when we have the unblinding on that, we basically have already the element of discussion with regulatory agencies, how we basically can evaluate that.
spk05: Okay, thank you. And then one further question, if I may, as we look forward to the update from the one-year follow-up from ACCOMPLISH Open Label Extension, just wondering, would you be able to provide the retention rate in terms of patients who've persisted in the OLE?
spk03: At the one, the data we will have to have all 47 patients. 57 patients. Great. Thanks very much.
spk10: This does conclude today's Ascendance Pharma third quarter earnings call. You may disconnect your line at any time and have a wonderful day.
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