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Ascendis Pharma (NASDAQ:ASND)
Q2 2018 Earnings Conference Call
Aug. 29, 2018 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to the Ascendis Pharma second-quarter 2018 earnings conference call. [Operator instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Scott Smith, chief financial officer. Sir, you may begin.

Scott Smith -- Chief Financial Officer

Thank you, operator. Thank you, everyone, for joining our second-quarter 2018 financial results conference call today. I'm Scott Smith, chief financial officer of Ascendis. Joining me on today's call are Jan Mikkelsen, president and chief executive officer; and Dr.

Jonathan Leff, chief medical officer. 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 of rare disease endocrinology programs, statements regarding the market potential of our pipeline candidates and statements regarding the planned 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 annual report on Form 20-F filed on March 28, 2018.

On today's call, we will discuss our second-quarter 2018 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 chief executive officer. Jan?

Jan Mikkelsen -- President and Chief Executive Officer

Thanks, Scott, and good afternoon. In this quarter, we continue to execute on our strategic goals, advancing toward our vision to build a fully integrated biopharma company. For TransCon Growth Hormone, we are completing enrollment in the fliGHt Trial, and our heiGHt Trial is progressing as planned toward top line Phase 3 results expected in Q1 2019. For TransCon PTH, we have completed the Phase 1 study and recently outlined a change in the development program.

This involves a Phase 2 trial with a planned long-term extension and the expansion of the Phase 3 program to a global pivotal trial, incorporating trial site in Japan and possible other Asian countries. Our updated plan is based on an analysis of how to strengthen the product profile, initial feedback from FDA how to reduce development risk and the relation of the market potential for TransCon PTH in Asia. In the Phase 2 trial, we plan to measure not only PK and PD of different fixed doses of TransCon PTH in adult patients with hypoparathyroidism but also at titration schedule designed to completely discontinue activated vitamin D and calcium supplements. We believe that TransCon PTH also has the potential to address a large market in the Asian countries.

In Japan alone, our research indicates that there are more than 30,000 patients with hypoparathyroidism. Therefore, we plan to conduct a global Phase 3 trial incorporating sites in Japan and possible other Asian countries. We believe this new approach will accelerate the regulatory findings in the Asian market by several years, thereby, broadening the world market potential by only moving back our U.S. filing by less than one year.

We believe our new plan also reduce development risk for the TransCon PTH development program by testing the proposed titration protocol before Phase 3 initiation and providing additional guidance for our Phase 3 power calculation. With this updated development strategy, we believe we are strengthening the commercial product, we can collect and learn from long-term extension data, potentially improve the label, decrease development risk and potentially broaden the commercial opportunity via geographic expansion. For our last product opportunity for TransCon CNP, we are moving to the Phase 1 study, which we plan to complete as planned in the fourth quarter of this year. Now I would like to focus on our core strategies and reflect on how Ascendis plans to create sustainable growth as our company matures.

Our vision is to create a biopharma company with several therapeutic areas, each containing multiple independent products created by our technology platform and not to establish Ascendis as a one-trick pony with a single product. We have built a pipeline of three independent product opportunities in endocrinology rare disease. All three of these wholly owned product candidates have the opportunity to provide sustainable growth through label expansion. We're also planning to create further growth by building new therapeutic areas outside of endocrinology rare disease.

Each of these new therapeutic areas will contain multiple independent product opportunities. Why do we believe we have strong fundamentals for sustainable growth? We have a unique technology platform, which can continue to deliver innovation and does not currently face significant competition. We continue to advance the TransCon technology and also to expand the platform to new areas such as localized delivery. Over the last several years, our platform has evolved from systematic delivery of an unmodified parent drug, such as with TransCon Growth Hormone, TransCon PTH and TransCon CNP, to also include localized delivery of an unmodified parent drug, tailor-made for specific unmet medical needs.

Our TransCon platform localized delivery capabilities have been developed through both internal resource, effort and our growth genetic optimality collaboration. I believe our localized delivery platform has now reached a stage where it can be applied across different therapeutic areas, and we are investigating these as we continue expanding our pipeline. In addition, we have a strong culture of innovation, one that values science and drives our product development efforts. We have already applied this mindset and expertise to build our pipeline of three independent product candidates in endocrinology rare disease.

By combining these essential fundamentals, our unique technology platform and culture of innovation, we expect to grow through a consistent stream of high value differentiated product opportunity as our company matures as a leading biopharma company. Another driver of sustainable growth and value creation at Ascendis is our plan to be -- to become fully integrated. It is logical that we forward integrate in endocrinology rare disease as a commercial company because we can realize strong synergies by having multiple products in a single therapeutic area. We are already making important progress toward this objective by establishing of initial commercial team discipline this is led by Tom Larson.

They are undertaking important projects to get a deep understanding of the market dynamics of each of our product candidate, including physician, patient and market access resource that will help us define future product positioning. Our goal is to build multiple independent therapeutic areas, each with a diversified pipeline. We have built our first pipeline in endocrinology rare disease, a pipeline that is diverse and present multiple potential label expansion opportunities to support further growth. Now we intend to put in place an additional source of growth with our pipeline in a new therapeutic area.

We expect to disclose this next therapeutic area at the beginning of next year. We believe this approach, with our technology platform and a culture of innovation at the core, can successfully create sustainable long-term growth. Now Jonathan will review our clinical progress.

Jonathan Leff -- Chief Medical Officer

Thanks, Jan. I am pleased to provide an update today on recent pipeline developments, starting with TransCon Growth Hormone. We are completing enrollment in our fliGHt or SWITCH trial in the coming weeks. As a reminder, fliGHt is enrolling subjects who switch from daily growth hormone to weekly TransCon Growth Hormone, with a follow-up of six months.

Results from the trial will strengthen our safety database and provide guidance for switching from daily to weekly growth hormones. Subjects are then provided the opportunity to roll into enliGHten, our long-term extension trial. In fliGHt, we have enrolled some subjects below three years of age. This will provide information and utilization of TransCon Growth Hormone in patients younger than those enrolled in the heiGHt Trial.

In parallel, our ongoing Phase 3 heiGHt Trial continues as planned. To date, all subjects completing the 12-month heiGHt Trial have chosen to enter the enliGHten long-term extension. We now have many dozens of subjects in enliGHten, data from which will be a key component of our filing package. Finally, we continue to work toward building awareness of our program among the pediatric endocrine community.

Next month, we are participating in two medical conferences. We are a proud supporter of the Growth Hormone Research Society Conference, a gathering of top opinion leaders and scientists in the field, and we plan to present two abstracts on our program at the European Society of Paediatric Endocrinology meeting. We are happy with the progress of our TransCon Growth Hormone program and increasingly excited about the prospects of a once-weekly product that importantly can provide the same efficacy, safety and tolerability as daily growth hormone. Turning now to TransCon PTH.

We are making progress on both the clinical and regulatory fronts. We have recently provided an update on the PTH development program, following our ongoing review of the clinical, commercial and regulatory landscape. We now plan to conduct a randomized placebo-controlled Phase 2 trial to be initiated in the first quarter of 2019. The trial will follow subjects for approximately four weeks of treatment.

We will evaluate pharmacokinetics as well as serum in urinary calcium levels in subjects with hypoparathyroidism treated with different fixed dosing regimens of TransCon PTH. We will also assess the ability to down titrate calcium and active Vitamin D supplementation. Following the trial, subjects may then enter into a long-term extension trial. We will also investigate patient-reported outcomes with a goal to incorporate those measures into our pivotal trial.

We expect topline data from the Phase 2 trial in early 2020. With this updated development strategy, we believe we are strengthening the clinical program in paving the way for a broader commercial opportunity and potential benefit to more patients with hypoparathyroidism. Finally, we continue to communicate the potential of TransCon PTH through our ongoing communications to the medical community. We intend to present data at the American Society of Bone and Mineral Research Conference in late September.

This will include a poster presentation on the final results of the Phase 1 trial, summarizing data from the full set of MAD cohorts, as well as a second poster on bone turnover markers from the Phase 1 trial. Our TransCon CNP program is also progressing, and recruiting continues for the ongoing Phase 1 trial. We are now dosing the second to last cohort, and we are on target with our plan to complete the trial during the fourth quarter of 2018. As a reminder, this trial is evaluating safety, tolerability and pharmacokinetics of TransCon CNP in healthy volunteers.

Our goal is to demonstrate that we can achieve continuous exposure to CNP at levels designed to optimize efficacy without adverse cardiovascular effects with a convenient once-weekly dose. In particular, we are looking to evaluate the cardiovascular risk profile. Our planning for initiation of a natural history study in achondroplasia is also well under way with a goal of trial initiation this year. We believe, this trial, which will take place both in the U.S.

and Europe, could help to enhance enrollment of future proof-of-concept studies in subjects with achondroplasia. We are excited about all three of our wholly owned product candidates for rare endocrine diseases. Each one continues to advance as we move forward with our clinical programs, paving the way to offer patients and physicians new and differentiated therapies. Now Scott will provide a financial update.

Scott Smith -- Chief Financial Officer

Thank you, Jonathan. Turning to our financial results for the three months ended June 30, 2018, let me review some highlights. For the second quarter, we reported a net loss of EUR 22.8 million or EUR 0.55 per basic and diluted share compared to a net loss of EUR 30.7 million or EUR 0.94 per basic and diluted share during the same period in 2017. The second-quarter 2018 results financial -- results reflect financial income of EUR 22.6 million due to foreign currency exchange rate fluctuations of our cash holdings.

Research and development costs for the second quarter were EUR 40.2 million compared to EUR 21.9 million during the 2017 quarter. The higher costs were primarily attributable to our TransCon Growth Hormone; continued execution and expansion of our Phase 3 clinical program, including the heiGHt, fliGHt and enliGHten trials and the ongoing development of the auto-injector; costs associated with our Phase 3 program clinical supply; and ongoing preparation of the manufacturing of TransCon Growth Hormone validation batches. These batches are required as part of the regulatory approval process and will be recognized as R&D costs when incurred. However, they go into inventory and may be used for either clinical trial supply or, upon approval, for commercial sale.

For TransCon PTH, costs related to the Phase 1 clinical trial and Phase 3 enabling activities, including manufacturing and device development. And for TransCon CNP, costs associated with the execution of the Phase 1 trial and ongoing Phase 2 enabling activities. General and administrative expenses for the second quarter of 2018 were EUR 5.2 million compared to EUR 3.2 million during the second quarter of 2017. We ended the second quarter with cash and cash equivalents of EUR 352.6 million and 41,841,590 ordinary shares outstanding.

We expect the increase in R&D costs to continue throughout the remainder of 2018 as we advance our wholly owned internal pipeline programs and invest in the TransCon technology platforms. R&D is expected to include, for TransCon Growth Hormone, costs associated with our Phase 3 program in manufacturing of validation batches as well as development and manufacturing of the auto-injector which will be used for administration. For TransCon PTH, ongoing IND-enabling activities, including nonclinical talks, manufacturing of clinical supply in validation batches, regulatory and device development activities as well as preparation for the initiation of our Phase 2 clinical trial. And finally, for TransCon CNP, costs associated with the ongoing Phase 1 trial and Phase 2 enabling activities, including nonclinical talks and manufacturing.

Our pipeline continues to advance with three wholly owned independent rare disease endocrinology product candidates in clinical development, each representing a potential worldwide market opportunity greater than $1 billion. We plan to continue to create long-term sustainable growth as we apply our innovative TransCon technology and product development algorithm in other therapeutic areas. Operator, we are now ready to take questions.

Questions and Answers:

Operator

Thank you. [Operator instructions] And our first question comes from the line of Jessica Fye with JPMorgan. Your line is now open.

Jessica Fye -- J.P. Morgan -- Analyst

Hey, guys, good afternoon and thanks for taking my questions. A couple from me. First, with respect to the new therapeutic area that'll be disclosed at the beginning of next year, can you provide a bit of a framework about what that disclosure might look like and how many preclinical programs we might hear about with that initial disclosure? I'm also wondering if you could elaborate on your comments around leveraging the TransCon platform for localized delivery. And lastly, can you talk about the status of completing the manufacturing of validation batches for TransCon GH?

Jan Mikkelsen -- President and Chief Executive Officer

Thanks, Jess. Some really good questions. I hope I can answer most of them. One of the question has been, how do we really select a new therapeutic area? And one of the element of Ascendis Pharma, always to have a strong focus on the patient.

So we start with really looking on where do we have a major unmet medical need as for the fundamentals. Then we see how can we build up a pipeline of multiple product opportunities where we can balance the risk profile high risk, low risk, meaning that we also like to use parent drugs already with established proven efficacy and safety. Then we integrate these elements together and see if we can make a highly differentiated product opportunity with a basic and nearly impossible for anyone else to develop. And what is the uniqueness we have now is that you have seen how we have enabled the soluble products.

This is what we call a product like TransCon Growth Hormone, TransCon PTH and CNP. And now, I'll be adding one more arm of our technology platform where we can make localized delivery of protein peptide small molecule, and we actually have now starting to establish data up to even more than a half a year, where we can see all these profile of active blocks. And by doing that, we actually have been through lot of different therapeutic areas, and we have now selected one, where we're starting to execute and making what I call proof of concept of the entire use of TransCon technology to this specific area. And what we would like to disclose at this time when we come to the early part of next year, the rationale for why we selected this area, how we see a huge opportunity to address major unmet medical need and how we at Ascendis can really develop a pipeline of highly differentiated product opportunities will be nearly impossible for anyone else to develop.

That is the data we would like to show you from the beginning. That was one question. The other question you asked me was related to the validation batches from growth hormone, and the validation batches from growth hormone is progressing according to our plan. Nothing is basic more to say that.

It's an activity that we initiated for 18 months ago now, so we're really just progressing through the entire supply chains of really doing the right in each single step for every process control. Beyond this, any questions?

Jessica Fye -- J.P. Morgan -- Analyst

Thanks, Jan. So just to clarify, are the -- is the new therapeutic area that you'll disclose going to be using this localized delivery approach? Or are those two kind of distinct priorities?

Jan Mikkelsen -- President and Chief Executive Officer

I think it will be likely that we're building up a pipeline where we apply the two arms of our TransCon technology potentially both in synergy but also in a position that it just give us a unique opportunity certainly to apply and develop completely from profiles of product opportunities that we didn't have an opportunity before.

Jessica Fye -- J.P. Morgan -- Analyst

OK. So is that to say that for some products within the new therapeutic vertical, they might use the local delivery and some might use systemic delivery?

Jan Mikkelsen -- President and Chief Executive Officer

Yes, that will be potentially the case.

Jessica Fye -- J.P. Morgan -- Analyst

OK. Thank you.

Operator

Thank you. And our next question comes from the line of Michelle Gilson with Canaccord Genuity. Your line is now open.

Michelle Gilson -- Canaccord Genuity Inc. -- Analyst

Hi, thanks for taking my question. I review the data that we're going to see in fourth quarter for TransCon CNP. Can you talk a little bit about the biomarker data that you'll be reporting in fourth quarter? And specifically, on cGMP, should we expect a growth response? And then what data are you looking for that would help you select the next -- the dosage for the next study in achondroplasia patients? And is there like a cutoff in pre-CNP or cGMP that you're looking for?

Jonathan Leff -- Chief Medical Officer

OK. Thanks. This is Jonathan. Thanks for the question, Michelle.

So in order -- the CNP Phase 1 trial will tell us a lot. Remember, this is in healthy volunteers. So first and foremost, it will evaluate the safety of the drug, which we assume is going to be very safe. And to date, it's been very safe.

But in particular, we're going to evaluate the cardiovascular risk profile, so paying attention to hypotension and tachycardia, since a major tenet of the target product profile is that we can give a once-weekly drug that is safe, that has elevated levels of CNP throughout the dosing intervals for the possibility of enhanced efficacy. So it all begins with the cardiovascular risk profile, which we're carefully evaluating. Secondly, we're evaluating whether the PK profile, in fact, supports the once-weekly dosing that we anticipate that it will and that it has in animals, and I'll remind you that our animal data has always been exquisitely predictive of human data. And then finally, we'll evaluate the three CNP levels, so not just the prodrug but how much CNP, the active moiety, is actually available, free during 24 hours at levels that we think can lead to appropriate efficacy.

So that's the main deliverables for the Phase 1 study. We will be looking at some other biomarkers, cyclic GMP and -- but those are not really the critical factors. Since these are healthy volunteers, we, of course, do not expect to see any growth in these subjects and its short-term single dosing. And in terms of the dose, we will -- and they're adults so they've finished growing.

And in -- the dose ranges that we are evaluating will be very broad and which will provide enough support for us to choose our initial dose selection for our Phase 2 proof-of-concept study.

Michelle Gilson -- Canaccord Genuity Inc. -- Analyst

OK. And then could you maybe talk about maybe some of your hypothesis for resistance mechanisms in achondroplasia patients to CNP therapy? And how an increased therapeutic window and ability to dose higher with TransCon CNP might overcome some of those challenges?

Jonathan Leff -- Chief Medical Officer

Sure. So we don't believe in the hypothesis of resistance, and we believe that the scientific data that's been generated in preclinical models argues strongly against that. So you can take mice, for example, that are replete in CNP and give them more CNP and cause growth. And the more CNP you give them, the more growth that you see.

So we think that you can overcome that there is no evidence of resistance actually. That remains purely a theoretical concern.

Jan Mikkelsen -- President and Chief Executive Officer

And if you actually believe in what we -- how we're treating diabetic people specific Type 2 diabetes, people saying you have insulin resistant there. But basic, the main therapy for Type 2 diabetes is still insulin. And I think it's well known, you have some kind of low level of persistence. You can get that, as what people have talked about.

But what the basic treatment we have seen is to overcome this resistance with a higher level. And why you have a level of diabetic resistance is because the organ is in some way trying to respond with a lack of efficacy, and this is why you suddenly all compensate the dishormone, and therefore, you just keep more and then you get the right effect.

Michelle Gilson -- Canaccord Genuity Inc. -- Analyst

OK. Thank you.

Operator

Thank you. And our next question comes from the line of Adam Walsh with Stifel. Your line is now open.

Neil Carnahan -- Stifel Financial Corp. -- Analyst

Hi, guys. This is Neil Carnahan on for Adam. On TransCon PTH, can you share some of the feedback from the post-Phase 1 meeting with the FDA? What's changed? And then can you discuss the rationale behind running a Phase 2 study now instead of going from Phase 1 directly into Phase 3?

Jan Mikkelsen -- President and Chief Executive Officer

I do think that if you go back to what we explained before, we actually came from the acceleration that we integrated a lot of different elements in change of the development plan, and this is the change of the development plan, and we made this change of development plan because we feel that we can get a much stronger product. We can be in a position we can really ensuring that this product would come up to many more patients. So it's done out from the assumption that we're going from something to something that is much better. This is the reason for our change.

The feedback from FDA was what I call extremely positive feedback, and Jonathan can comment further on that. We came into a position where the basic have no comes to our preclinical safety to our CMC packet or device development. And they also gave us some kind of opportunities, potentially to have possibility to strengthen the product profile with potential at data label. And this is some of the thing we're now exploring, and we're feeling really, really strongly supported by FDA.

And you can also just go back to see if there is understanding of this disease area, which are really, really high from the NATPARA. I actually thought where the -- one of the first thing really came with and proposed better product profile to really treat patients with hypoparathyroidism, and I think they recognize that we have a profile that really potentially can fulfill this criteria from an optimal target profile for a product for this patient group. So we're feeling pretty confident what we're doing. It's really for the benefit of the product opportunities, and we're feeling that we will have a much, much stronger product opportunity now with this -- our current development plan than we had before.

Neil Carnahan -- Stifel Financial Corp. -- Analyst

OK. Then I just have one follow-up on the same topic. Just on study design, any details on how many patients you plan to enroll, whether it will be a global study -- you said, I understand, maybe a placebo-controlled study? Would the control arm be supplemented with Calcium and Vitamin D?

Jonathan Leff -- Chief Medical Officer

So we will evaluate patients with hypopara who are on Calcium and Vitamin D, as essentially all of them are. It will be placebo. There'll probably be 3 different arms of fixed dosing, and not a large study, I mean, probably in the 40 range. Is your question Phase 2 or Phase 3? My response is about...

Neil Carnahan -- Stifel Financial Corp. -- Analyst

Yes, the Phase 2.

Jonathan Leff -- Chief Medical Officer

Yes, OK. Yes, so probably in the 40 to 50 size range. Does that answer your question?

Neil Carnahan -- Stifel Financial Corp. -- Analyst

Yes. Thank you, guys.

Jonathan Leff -- Chief Medical Officer

Sure.

Operator

Thank you. [Operator instructions] And your next question comes from the line of Jim Birchenough with Wells Fargo Securities. Your line is now open.

Unknown Speaker

Good afternoon. It's Nick on for Jim this afternoon. Thanks for taking our questions. First, a couple on the Growth Hormone program.

I''m wondering if you have patient reported outcomes or quality-of-life tools in the heiGHt and fliGHt studies, if there is a validated tool. And you also mentioned a pro for hypoparathyroidism, so similar question there in terms of what's available and validated.

Jonathan Leff -- Chief Medical Officer

Sure. So in heiGHt, we do not. But in fliGHt, we do. So we have some preference in satisfaction questionnaires in the fliGHt trial, specifically comparing their experience to the daily growth hormone they're coming off of to the new weekly TransCon Growth Hormone they're going onto.

Unknown Speaker

Thank you. And then as a follow-up from that. So if you see improved compliance and persistence driven by this increased level of satisfaction, how much bigger do you think the Growth Hormone market can become?

Jonathan Leff -- Chief Medical Officer

Well, just any increase in compliance rates, even one percentage point is increasing the market, so it's proportional to the amount of increase that we'll see. So we won't know what their previous compliance was going into the fliGHt Trial. We'll, of course, know what it is in the fliGHt Trial. But you also asked about the PTH trial.

So we are developing our own patient reported outcome symptom score for the PTH program, and having the Phase 2 trial now to test that then will allow us to hopefully validate that in the Phase 2 trial and utilize it in its full form in the Phase 3 program, which could, of course, potentially lead to inclusion in the label, theoretically.

Unknown Speaker

OK. And I think that's a segue to my next question, which is, so is there a recognized strategy for down titration of Calcium and Vitamin D that's acceptable to regulators that could also result in a label claim?

Jonathan Leff -- Chief Medical Officer

So there's some experience from the recent trials that have gone on, and I don't think anyone really cares specifically how you do it, how fast you do it. What matters is that you do it safely in where they end up. So if you end up off Calcium and Vitamin D, maybe you could talk about that. And we will be guided by previous experience in this area.

But no one is really too picky about exactly how you do it as long as it's done safely and you lower the treatment burden.

Unknown Speaker

And do you think you need to be off Calcium and Vitamin D for three months, six months? What do you think is the time line without taking those supplements...

Jonathan Leff -- Chief Medical Officer

So there's no -- for numbers of patients being off, it will be what it is at the end. We feel that a large proportion of patients will ultimately be free of Calcium and Vitamin D because the PTH will appropriately manage them. But what exactly that number is, we'll determine in the Phase 3 trial.

Unknown Speaker

[Inaudible] duration.

Jan Mikkelsen -- President and Chief Executive Officer

Yes. We have a strong belief that potentially most of the patients can get up because if you look to the continuous infusion studies that have been conducted both in the pediatric and adult patient population, you are eliminating all supplement, meaning activated Vitamin D and Calcium supplement in this patient group when you start the infusion or pump studies. So we -- from that perspective, it makes sense that we should end in the same situation, where it should be possible to basically eliminate the activated Vitamin D and Calcium supplement compared to a standard population at that stage.

Unknown Speaker

OK. Thank you. And then on the Phase 3, would that -- do you think that would need to be an active controlled study, say, with NATPARA, for example?

Jonathan Leff -- Chief Medical Officer

Background, Calcium and Vitamin D, the standard of care. It's in control.

Unknown Speaker

And then just answer the -- I know you're going to wait until next year to elaborate on the new therapeutic area, but it seems as if you have the possibility of localized delivery, which might be good for maintenance therapy. Systemic delivery might be very good for acute therapy. Is oncology something that might fit the bill?

Jan Mikkelsen -- President and Chief Executive Officer

I think I know you're extremely excited. We're really excited ourselves, but you need to wait until we disclose it.

Unknown Speaker

Fair enough. Thanks for taking the questions.

Operator

Thank you. And I am not showing any further questions at this time.

Scott Smith -- Chief Financial Officer

Thanks, everybody. Have a great day. Bye.

Operator

[Operator signoff]

Duration: 41 minutes

Call Participants:

Scott Smith -- Chief Financial Officer

Jan Mikkelsen -- President and Chief Executive Officer

Jonathan Leff -- Chief Medical Officer

Jessica Fye -- J.P. Morgan -- Analyst

Michelle Gilson -- Canaccord Genuity Inc. -- Analyst

Neil Carnahan -- Stifel Financial Corp. -- Analyst

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