Good morning, ladies and gentlemen and welcome to the Q4 2020 Ascendis Pharma Earnings Conference Call. [Operator Instructions] This call is being recorded. I would now like to turn the conference over to your host, Mr. Scott Smith, Senior Vice President and Chief Financial Officer of Ascendis Pharma. Please go ahead, sir.

Thank you, operator. Thank you everyone for joining our full year 2020 financial results conference call today. I am Scott Smith, Chief Financial Officer of Ascendis. Joining me on today’s call are Jan Mikkelsen, President and Chief Executive Officer; Dr. Mark Bach, Head of Clinical Development and Medical Affairs for Endocrinology Rare Diseases; Jesper Høiland, Global Chief Commercial Officer; Dr. Dana Pizzuti, Head of Development Operations; and Dr. Juha Punnonen, Head of Oncology. Before we begin, I would 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, our progress on our pipeline candidates and our expectations with respect to their continued progress; statements regarding our strategic plans, our goals regarding our clinical pipeline; statements regarding the market potential of our pipeline candidates; and statements regarding our regulatory filings. These statements are based on information that is available to us today. Actual results or events could differ materially from those in the forward-looking statements and we may not achieve our goals, carry out our plans or intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these statements. Our forward-looking statements do not reflect the potential impact of any licensing agreements, acquisitions, mergers, dispositions, joint ventures or investments that we may enter into or terminate. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statements section in today’s press release and the Risk Factors section of our prospectus supplement filed on July 9, 2020 and our Annual Report on Form 20-F being filed today. Please note that our TransCon product candidates are investigational product candidates and are not approved for commercial use. As investigational products, the safety and effectiveness of the TransCon product candidates have not been reviewed or approved by any regulatory agency. None of the statements made on the conference call regarding our TransCon product candidates shall be viewed as promotional. On today’s call, we will discuss our full year 2020 financial results and provide a business update. Following some prepared remarks, we will then open up the call to questions. I will now turn the call over to Jan Mikkelsen, our President and Chief Executive Officer.

Thanks, Scott and good afternoon everyone. For Ascendis, 2020 was a year to remember. We succeeded as a team and were able to meet and in some cases, exceeded all our cohort goals in 2020. I am proud to be able to say that the Ascendis team was adaptive, creative and focused on achieving the goals we outlined at the beginning of last year to bring our TransCon product candidates to patients as fast as possible. For 2021, we are well-positioned to continue to execute and achieve the milestones we have laid out across all of our 5 independent product candidates. Going back, the important of the science, one of Ascendis core values is really at the center of what we do, 365 days a year. Our understanding of the biology and the science it was drives our top development process. I see it again and again. If we stick to the science, understand and respect the biology we will be successful. With our algorithm for product development focused on the patient and the unmet medical need, combined with the TransCon technology, we have a powerful platform that has allowed Ascendis to create not just one potential blockbuster product candidate, but a portfolio of five potential blockbuster candidates in two therapeutic areas with more to come. Beginning with TransCon growth hormone, throughout the development, we have kept the patient needs in mind. From the beginning, we were committed to build on the last 30 years of knowledge with daily growth hormone and other long-acting growth hormone programs. We designed our TransCon growth hormone to have a similar tissue distribution pattern, receptor activation and exposure as seen for daily growth hormone once somatropin is released from the TransCon growth hormone product. For more than 30 years, most of the companies have…

Thanks a lot, Jan. Turning to our financial results for the full year ended December 31, 2020, we reported a net loss of €419 million or €8.28 per basic and diluted share compared to a net loss of €218 million or €4.69 per basic and diluted share during 2019. Now, let me run through some components of these results. Research and development costs for 2020 were €260.9 million compared to €191.6 million during 2019. R&D costs in 2020 reflect continued advancement of our pipeline with the primary drivers of the increase, including an overall increase in personnel-related and R&D infrastructure costs and for TransCon growth hormone or lonapegsomatropin, costs were higher due to buildup of pre-launch inventories as well as increased clinical trial activities. As a reminder, we currently expense manufacturing costs of lonapegsomatropin as R&D in advance of our anticipated product launch. At the time of product approval, a portion of these R&D costs maybe reversed and capitalized as inventory, which will result in a one-time benefit to R&D costs. For TransCon PTH, costs were higher primarily due to device development and increased clinical trial costs. For TransCon CNP, costs were higher primarily due to increased manufacturing and clinical trial costs. And finally, for our oncology therapeutic area, costs were higher due to increased manufacturing and preclinical activities primarily related to TransCon TLR7/8 agonist and TransCon IL-2 beta/gamma. Selling, general and administrative expenses for 2020 were €76.7 million compared to €48.5 million during 2019. These higher costs primarily reflect an increase in personnel-related, IT and other infrastructure costs as well as expenses associated with the continued build-out of our commercial capabilities. Finance income and expenses in 2020 included a foreign exchange rate loss of €78.9 million compared to a gain of €7.7 million in 2019 primarily related to unrealized…

[Operator Instructions] Your first question comes from Michelle Gilson from Canaccord Genuity. Your line is open.

Hi, thank you for taking my questions. I guess the first one can you maybe discuss the cadence for TransCon GH of getting on to the formularies, how did that happen over the course of the year? And then my second question for TransCon PTH, from a safety perspective, is there a difference between replacing PTH at physiological levels in hypopara patients, I guess at the dosage you are evaluating versus adding pulses of PTH to stimulate an anabolic effect? And then I guess, at the doses that you are evaluating for TransCon PTH, would you expect there to eventually be a black box warning or limitation duration therapy like there is for Forteo given these different effects on the bone?

Thanks, Michelle. So, before I potentially will turn it over to Jesper, I couldn’t potentially take a little of the PTH question that you take up. And let me just repeat what we are doing with TransCon PTH related to bone structure. If you have an untreated HP patient, they have a higher bone density, because you basically have an unnatural low bone turnover, because you have not the physiological PTH level of PTH. And if you look on the serum level of PTH, it’s well documentated in the literature that you basically see and basic a curve that have a peak to trough about 30% during the entire 24-hour cycle. And what we saw in the 6 months open-label extension data, what we saw that when we restored physiological PTH level, we basically activated the normal bone turnover that you see in a normal human being that have no issues related to potential lower level of PTH. We saw that by accelerating at an higher level of both the anabolic and catabolic bone markers, but still being placed in what we call the higher level of the normal levels. And what we saw was the associated consequence of that. We also saw that this bone density that is abnormal dense because it actually have a structure that basic are not like a normal bone, because it has no bone turnover start to be normalizing. So therefore, we saw that trend to approaching the normal level with our SAT score is defined as zero. That is what we observed in the 6 months data. This is a continued process, where we saw the main effect on trabecular bone, if we basically looked on cortical bone that was not the same kind of decline in SAT score, it was basically stable,…

Thank you very much.

Thanks a lot.

And your next question comes from the line of Jessica Fye from JPMorgan. Your line is open.

Hey, guys. Good afternoon. Thanks for taking my question. This one might be for Dana. Can you tell us whether the necessary pre-approval inspections have taken place yet for TransCon growth hormone? And your expectations for those being completed prior to the PDUFA given any COVID travel issues? I know you said multiple times on the call that you guys expect approval in 2Q. So it sounds like maybe things are on track there, but that’s the first question. And then second kind of building on the last question, thinking ahead to the 12-month open-label extension data for the PTH Phase 2 trial coming up in 2Q. Can you talk about what you would expect to see on BMD at the 12-month time point and what that means for the product? I guess, more specifically, at what point do you expect to have clinical data that will demonstrate that the normalization that you’re seeing in BMD early on does not overshoot and lead to below normal BMD? Thank you.

So Dana, would you take the first question?

Yes. As far as the inspections go, we’re finally starting to see a bit of movement from the FDA in terms of their activity. In fact, we’ve recently had a GCP inspection at a site for our number one enroller of growth hormone. So that was completed last week. As far as the manufacturing inspection goes, we are still in communication with the FDA about when that would be scheduled. And there are a couple of opportunities in terms of alternate approaches that are available. So we still feel that we sort of can address these issues before it has any impact on the PDUFA date. So – but we’re also noticing that FDA is doing more manufacturing inspections outside the U.S. as COVID is somewhat subsiding in certain places, okay.

I think, Jess, going back to your second question, and I think we need to take it into the perspective at my initial comments to Michelle because there, we basically lay out that what we’re seeing now is just a normalization of the bone structure that you expect to do when you actually are coming into a replacement therapy and observing that you providing PTH in physiological level. And you can also see the differentiation between trabecular or cortical bone. If you look in the data, you can see where we expect to see the biggest remodeling is on trabecular bone, and we’re also seeing the right structure coming in of the bone. So from my perspective is that I cannot see any worry about that because that is not normal biology, and we have children that have been 10 years on infusion pump growing up with normal bone structure on infusion pumps. We have adult that’s sitting 5 to 6 years on an infusion pump and observing all the same thing. And I think everyone that just have a clear understanding about an infusion pump and insulin and other things like that will acknowledge there is a total flat curve you provide with infusion pump. So I really lost in the logic where it’s coming in because what we’re just seeing is normal biology, which we see on a lot of other elements. We see the same thing with urinary calcium, we see the loss of soft tissue classification, we see expecting all the normal physiology. I cannot change physiology. If you want to have a home replacement therapy, then you need to expect to see the outcome of being a normal human being.

Okay, thank you.

We just follow the science, and that is what we’re doing. I cannot change science. I can follow and adapt to science.

And your next question comes from the line of Alethia Young from Cantor. Your line is open.

Yes. Thanks for taking my question and congrats on the progress. I just wanted to flip maybe two questions. One, just clarifying on the formulary, maybe I missed it. Do you think that you’ll have like kind of a broad formulary that could include adults in some of the other growth hormones? And then the second one is just in Oncology. As you continue to kind of do work there, do you feel like there is one target between IL-2 or TLR7 that has kind of a greater target risk or do you kind of feel like it’s somewhat equal and you have a fair amount of confidence in both? Thank you.

Jesper, I actually think that what you are now addressing is part of our important long strategy. And for every product, one step is to getting approved, and we have seen actually being long-active product being approved now in the U.S. without being launched because there is not what I call an associated launch strategy where the product access is meaningful to launch. So what you’re addressing is the key element in our entire long strategy, and this is where we have a huge comfort in what we’re doing because we’re not only feeling that we are providing a best-in-class product opportunity, but we’re also providing into the first-in-class growth hormone deficiency market for the pediatric children. So Jesper, do you have anything further to add? Jesper Høiland: Yes. Of course, just to add that in the initial phase, we anticipate to get the pediatric indication which is the vast, vast majority of the market whereas the adult indication only represents 10% to 12% of the market. So, we will enter into the lion’s share of the market and with the pediatric indication.

And going back to Oncology, you saw we built up a pipeline of three independent product opportunity endocrinology rare disease. We will continue to build up our pipeline in Oncology. What we have with our two hopeful clinical programs now in 3 to 4 months from now, we really have a paradigm shift how to treat tumor. And what we really want to do with a tumor is make a kick start. We want to kick start the hemogenic response into a solid tumor. This is how we think. And at the same time, we come with what we believe can be a next generation of how to do hemological stimulation. We have seen the success of checkpoint inhibitor, but we’re also seeing the limitation. When we see how potent our TransCon IL-2 beta/gamma is really unique compound. And this is why we see and build on the entire immunocal understanding from Juha and his entire group is to build more product opportunity. So we basically are fully integrated Oncology company with all the aspect of the hemalogical immune cycle, where we have addressed all part way. And this is our vision, how we want to be a major player in that segment, too. Juha, do you have other comments?

I think just to add that, I think we believe that they both have very unique properties and we’ll have a unique opportunity in the treatment of cancer. They obviously are very different product profiles, one being intratumoral administration, one being systemic. We expect them to also work very effectively together. Hard to compare with each other, but I think our point really is that they both have their unique spot in the treatment of cancer and will also work additively when treating these patients.

So I think the vision and thinking we have and why we believe we wanted to be a player in Oncology even if we would think that is so different environment compared to rare disease endocrinology, we believe of the power of the TransCon technology that give us such a major enhancement to make highly differentiated product opportunity basic no one else can make. And by doing that and build on our algorithm on basic validated target, validated parent drug, we also believe we can have be in the same successful way in our development. And when we go to the third product opportunity, we basically will build on what we have done in TransCon IL-2 beta/gamma, TransCon TLR7/8. That will be a strong synergy what we’re doing in the third one. This is how we want to think how we want to make a paradigm shift.

Great, thank you.

And your next question comes from the line of Joseph Schwartz from SVB Leerink. Your line is open.

[Technical Difficulty] CNP in your opening remarks, but I was just wondering if you could just elaborate a little bit more on the program. How did you choose your ACcomplisH study doses and how have you designed your ACcomplisH China study in order to leverage your findings in the accomplished study in the U.S. and EU trial? And how should we interpret these two results when they emerge later in 4Q?

We just lost the beginning of it, but I believe that what you’re referring to is our TransCon CNP program.

Yes, that’s correct, TransCon CNP.

Yes. I think that is what you’re referring to. And I actually believe that we’re having a major effort now to understand this, I think, important disease. We know how CNP has functioned, we have known that for 50, 20 years. We know the biology and the science behind it, and that is what have directed our two program with TransCon CNP. We are now in a position that we have a unique product opportunity with TransCon CNP, which can provide a continuous exposure for up to 1 week with one single dose. And we know we can do it in an extremely safe manner. And we do it now in two independent product you can say, two independent clinical trials. But what we really want to do is not only look at one single parameter. We are aiming to go down to the newborn children as fast as possible. We were, because of our unique safety profile, managed to start already in age 2, and we are dedicated to move it down as early as possible, as fast as possible down to newborn children because we know if we want to address comorbidity, some of them are irreversible happening in a very, very early stage, and that is really what we want to do. Mark is leading a major effort in Ascendis how really to expand the program, involving a lot of different comorbidities and I do not know, Mark, if you can say a few words how you also use our use national history study now and try to integrate the development in comorbidities and try to develop them in a unique clinical development plan so we potentially can address not only height but also the other comorbidities.

Sure. I can say a few words. Thanks, Jan. So we have an ongoing natural history study, which is providing us very valuable information. And one of the things we find when we talk with individuals with achondroplasia is there – the height is not the biggest issue that they want us to look at, but rather a lot of the comorbidities, issues with frame and magnum, issues with otitis media, issues with airway. And so for us, it’s been very important not just to be prepared to look at height but to really understand the comorbidities better. And we are using the natural history study to try to gain information about the comorbidities frequency, time of occurrence and to give us enough information to successfully study them in a clinical trial. So I think that’s what Jan is alluding to, and it’s actually providing us even early on what we think will be useful information. Thanks, Jan.

So what Mark is designing is that we can integrate that knowledge into our clinical development now.

Right, right.

Okay. Great, thank you. And then my next question is on TransCon PTH. Based on our conversations with endocrinologists, some docs prefer to see T scores over Z scores in adults. And our question is, do you have plans to present this and how does that compare to T scores?

T score and Z score are completely different independent benchmark measuring. Z score is to a normal population, and this is also what we’re using in growth hormone deficiency when we talk about height. You typically use a Z score because that is the most relevant one. When you talk about osteoporosis compound, you often use a T score because this is where you basically are trying to compare what was optimal for the person. And – but I think that is not really the aim of this year. We also can look on the T score. It’s basically providing the same guidance and the same thing that we see with the S score. But as we have a hormone replacement therapy, it’s typical what you want to do, you want to do a normalization of all different elements of the body to be as a normal human being. This is the definition of hormone replacement. If you go to osteoporosis, you want to redo, reset what we call a national decline in some of the bone structure. And this is why you, some way, referring into a T score. But this is coming from a demographic that is not building on a patient population that has a complete different dense bone structure than what you see in other places because there is a dense structure that is happening to what we call a non-national process where you’re basically just building up the a dense bone structure because you are no turnover. That is not the same thing to have a healthy bone structure. No one is ever claiming that the bone structure you have in HP patient is healthy, even it’s more dense because it’s a old bone structures. So I think it’s not meaningful to compare to a T score. Sure, we have the data. We have looked at it. What is meaningful for hormone replacement therapy is compared to a Z score.

Okay, great. Thank you for that.

And your next question comes from the line of Anita Dushyanth from Berenberg Capital. Your line is open.

Hi, good afternoon. Thanks for taking my questions. Just a couple here. Could you please remind us the sort of timeline in terms of the pediatric Phase 3 trial that would commence in Japan? I know you have applied for the CPN. So when – is it sort of likely to – so you’re going to get the green signal to go ahead? And then in terms of the HP Phase 3 trial, would there be any change to the trial design itself in terms of inclusion or exclusion criteria of patients based on your 6 month data?

I think the first question is reflecting our pediatric growth hormone deficiency trial, our riGHt trial. Mark, could you give us the status of our riGHt trials? You have extensive experience in Japan.

Yes, absolutely. I actually spent – I spent 10 years of my career living and working and doing clinical research in Japan. And similar to the U.S., when you file – once you file a CPN, unless they object, then 2 to 4 weeks later, you can start your study. And so that’s usually not rate limiting. The approval is usually not rate limiting. But in any case, that study is actually going ahead and is in the screening phase. So I think it’s – there is no roadblocks to continuing the development in Japan.

I think from a company perspective, we will be in a unique position because it looks like all our product opportunity in three different indications, pediatric growth hormone deficiency, adult growth hormone deficiency and HP, will nearly be aligned for approval nearly in the same time period. [indiscernible] is a unique situation for us to find an optimal way to make a commercial effort in this region, would typically involve Japan, South Korea and other major country outside Greater China in that region.

Okay. And then as far as the Phase 3 HP trial, would there be any changes in the trial design based on the 6 month data?

Related to the 6 months data we have disclosed in our open-label extension, we will basically have the same patient population coming into the trial as we saw in our Phase 2 trial. That will not be – I have to think this. Mark, you can correct me. I think it’s a little bit broader this time because there is a patient population as HD H1 patients. That we also have included it because there was a hugely benefit to have a normal physiological level of PTH like a post-surgical one. So this kind of patient population also being opened up in the Phase 3 trial. And we also believe that it’s important that they have an opportunity to get an optimal PTH treatment with a physiological PTH level 24 hours. And from that perspective is we actually are having the other change is basic in the – where we looked about what was really difficult in the Phase 2 trial and what – why we – you always look on screening failure. Why do we have screening failure? What is the driver of the screening failure? And we actually realized there was really, really difficult for a HP patient just to have a normal serum calcium of 8.3. It was hard just by standard of care, taking activated vitamin D, taking calcium supplement to make them up to 8.3. The normal calcium is typically in the 9. In the trial here, we have been seen 8.3 and 10.3. But we are in a position that we basically lower the interim criteria, so you can go down to 7.8 to be part of the trial. And it was basically to be ensure that all this patient group, which was impossible basically to be in a position to titrate up to that. Mark, do you have other element or a thing I have forgotten?

Yes. I mean, there is a few other subtle differences between phase, basically relying on what we learned in Phase 2 in going to Phase 3. So in Phase 2, again, for the first efficacy trial, the dose was fixed for the first 4 weeks and then allowed to titrate in Phase 3 or allowed to titrate from the beginning, which makes clinical sense. And in Phase 2, the upper dose limit was lower than what we’re allowing Phase 3 based on what we’ve learned in Phase 2. So there is a few small things. And then the other is that in Phase 2, we validated disease-specific quality of life instrument that will then be used in Phase 3 so as an outcome measure. So I think those are the primary differences between the two trials.

Thanks Mark.

Great, thank you.

Sure.

And your next question comes from the line of [indiscernible].

Hi, guys. Thanks for taking my questions. I guess two from my side. So first one on TransCon growth hormone, now that you have the 2 years data, can you remind us how long you’re planning to continue following up these patients? And what will you do with this data? And do you anticipate to submit these data to the regulators as well? And the second question is on TransCon PTH, great to see that still almost all patients are on therapy in the open-label extension part. Maybe moving – jumping a few steps ahead towards commercialization, what are the lessons you learned from NATPARA? Why do you think TransCon PTH will be commercially more successful? Thanks.

Okay. Yes. Thanks a lot. Thanks a lot for the question. The first one is basically addressing what do we do in the fliGHt in the trial that we continue on in our Phase 3, where we have an open-label extension for both from the fliGHt and the heiGHt trial, which continue on it. And currently, we see patients coming to acceleration that they basically are reaching final height. We are in a position we will continue this open-label extension trial. So we basically can continue to collect unique information about how we basically are providing a treatment where every child have an opportunity to achieve their expected height – not only height, but also other elements like body composition and other things like that, that we’re measuring. And we think that is a really important thing. We are running our trial in multiple countries, and we hope and expect still to continue in most of this country. But Mark, you are sitting with all the post commitment now here, and perhaps you can give a short update about what we expect to continue to execute. But in summary, we like to continue to give you data for this important trial.

Sure. Do you want me to add a couple of comments, Jan?

Yes.

Yes. Okay. So as you know, the enliGHten trial, which is the combined ongoing study from fliGHt and heiGHt is continuing. And as Jan said, we’re getting very nice data on it. Some of the patients are indeed getting towards their near adult height. Others have some room to go. I think, at least for the time being, the study is continuing, and I would expect both clinicians and regulators may have some interest in having some longer term data. And so at this point, I think it’s premature to make a commitment on how long it will continue, but it is certainly continuing for now and delivering valuable data. I think over the next month, we’ll have a better idea about what longer term data we want or would need to collect. But certainly, it’s ongoing now and really still giving very useful information.

So I think addressing your question. What is the learning from NATPARA? Even if you develop a product like adjunct to standard per care, there is still a huge need for such a product, and then you can nearly imagine what is the need would be when you have a hormone replacement therapy and not just an adjunct therapy. That is the differentiation. We are competing in two different segments, one is an adjunct therapy. We are positioned TransCon PTH as a hormone replacement therapy, addressing all aspects of the disease, both short-term symptoms, long-term complications. That is the main difference between the two product, it is like an apple and an orange in my view.

Okay. Thank you very much.

And last question comes from the line of [indiscernible] from Wells Fargo Securities.

Hi, thanks for taking my question. So a couple on the CNP program and a couple on the PTH program, for the CNP program, to identify a dose to move forward into the ACcomplisH China trial, do you need to wait until 4 blinded dose cohorts in the US/EU accomplished trial to be completed? Or could you unblind each dose cohort as you go? And then any plan to open a US/EU dose expansion trial for the CNP program? Thanks.

Great question. I think we are in a position that we are aiming not to unblind it. We think it’s really, really, really important to not to unblind it. But we also believe that it’s possible on a blinded basis to be in a position to have some good guidance that we potential are in acceleration that we have an active dose. We have a lot of primary outcome we’re looking in. We also have a series of biomarkers that we are addressing and other elements that could give us a guidance about where we are. And this is where Mark and his team is really developing how really to look on all this data and be convinced that we have something that is meaningful to move forward in a dose escalation and dose expansion on it. And that is the task of Mark and his people to be quite sure that we’re confident that we see something on a blinded basis. So we don’t want to unblind the trial before everything is done. The second one, this is up to the situation. Yes, potentially, we will do that depending on that. We are in a unique position to VISEN Pharmaceuticals and the experience for the team to conduct this trial that we have so fast access to patients in Greater China. But we’re also seeing that is – we’re also seeing the same thing in Europe and U.S., in Australia and other places. So there is interest for our trial, that will not be limited to any kind of limitation in how many patients we want to take in. So I do not know, Mark, about our plans to potentially open up an European/U.S. arm in the dose expansion. I don’t think it’s something we really have decided on yet.

No, we had not discussed it for now. Things are going well, both in the global trial and the China trial. So it’s not something we talked about so far. But certainly, should it be necessary, we could talk about it, but not on the agenda right now.

Got it. And on the PTH program, what kind of interest are you seeing in the PaTHway Phase 3 trial? Are there enthusiasm due to the data you reported from the Phase 2 open label extension? And then is the safety database from 76 patients considered sufficient for the regulators? Thank you.

That’s two questions. The first question is how high is the understanding about what we can provide with TransCon PTH throughout the HP patient society and physicians. I have never seen anything like that before. When we see the arm assessment how people get their life back again. And sure, it is helping us to go out and make a broader indication about it like in the conference, but we already see a huge enthusiasment everywhere, so to be part of this trial. So I believe that when I see how TransCon PTH is a game changer. We are addressing the life of more than 200,000 patients just in Europe, U.S. and Japan. And what we have seen basic by having 58 out of 58 basic continue on it, everyone has a huge, huge benefit of this treatment. And related to the safety database, I think, Dana, you can explain how we’re building our combined safety database both from our Phase 2 trial and also what we will see in our Phase 3 trial.

Yes. For the sort of approval, as we discussed with the agency, too, in our – and the Phase 2 meeting, the combination of the information from the Phase 2 and the Phase 3 will satisfy the criteria for the safety thresholds for the applications. So did that answer your question?

Got it. Thank you. Yes, very helpful. Thank you.

And ladies and gentlemen, this concludes today’s conference call. Thank you all for your participation, and have a wonderful day. You may all disconnect.

Thanks a lot.

Thanks.