Tim Van Hauwermeiren - CEO Eric Castaldi - CFO.

Yatin Suneja - SunTrust Jason Butler - JMP Securities Boris Peaker - Cowen Ted Tenthoff - Piper Jaffray Chris Parrish - Nomura Sandra Cauwenberghs - KBC Securities.

[Abrupt Start] A press release with our second quarter business update and half year 2018 financial results became available earlier today and can be found on the News and Events section of the company's website at www.argenx.com.

Before we start, I'd like to go to Slide 2 to remind you that forward-looking statements may be prevented during this call. This may include statements about our future expectations, clinical development and regulatory timelines, the potential success of our product candidates, financial projections and upcoming milestones.

Actual results may differ materially from those indicated by these statements. argenx is not under any obligation to update statements regarding the future or to conform these statements in relation to actual results, unless this is required by law. I'm joined on the call today by Tim Van Hauwermeiren, CEO of argenx; and Eric Castaldi, CFO.

On Slide 3, you'll see a brief agenda for the call.

Tim will highlight recent updates from our efgartigimod ARGX-113 program, including the full data set we presented at the American Academy of Neurology Annual Meeting from our Phase II clinical trial in myasthenia gravis, feedback from the FDA around our upcoming planned Phase III trial in myasthenia gravis, initial data for our subcutaneous formulation of our ARGX-113 product candidate and the first cohort of patients in our Phase II proof of concept trial in pemphigus vulgaris.

We will then move on to provide update from our other clinical programs, including ARGX-110, our collaborations and our productive Innovative Access Program that continues to feed our antibody pipeline. Eric will then provide financial results for the half year before we start the question-and-answer portion of the call.

With that, I would now like to turn the call over to Tim..

the same dose level of 10 milligram per kilogram, the subcu formulation, was comparable to the IV formulation that we have used in our clinical trials to date across several measures, including half-life, pharmacodynamics and tolerability.

With the pharmacodynamics measures, we saw a similar reduction curve of total IgGs to the IV formulation, which you can see on Slide 16. Additionally, we observed with our subcu formulation that we can maintain a steady state IgG reduction, which could translate into a subcu maintenance dose for patients.

We simulated 1 dosing schedule in the study shown on the right side of Slide 16, which was an IV loading dose followed by weekly subcu infusions where we were able to maintain a steady state IgG reduction.

We used a 300-milligram fixed dose, which translated to keeping the IgG reduction at 50%, but with various doses or dosing schedules, we have been able to simulate steady state IgG reductions anywhere between 30% and 75%. Overall, the data show that we have a subcu product candidate that is ready to move forward.

The subcu formulation would utilize a patient-friendly needle size of 27 gauge and demonstrates some key manufacturing features, including a high product concentration, low viscosity and optimal stability.

We intend to launch our Phase III MG trial using the IV dose as our overall strategy here speed to market, but we will continue to expose subcu dosing schedules to advance the product candidate forward.

As you can see, we've had a very busy quarter around our efgartigimod product candidate and now are awaiting Phase II proof of concept data from third beachhead indication, immune thrombocytopenia or ITP. We held a breakfast event in June to outline the opportunity of efgartigimod within the current ITP landscape and to invited Dr.

Catherine Broome from MedStar Georgetown University Hospital to present. As part of the event, Dr. Broome presented an overview of current therapies and discussed the struggle as a physician to manage ITP patients, since each patient responds differently to therapy.

The current treatment paradigm for ITP patients is not linear and patients cycle on and off various drugs throughout the life-cycle of the disorder, including corticosteroids, TPOs, rituximab and IVIG, which is most commonly used in a rescue setting.

Even with all of these available therapies, many patients are still under-treated, poorly managed or long responding to therapy so there is a real need for better options. The differences in how patients react to therapy may be due to the many pathways that lead to ITP.

At argenx, we are building our understanding of how pathogenic autoantibodies in ITP play such a central role in the disease and the detrimental ways in which they affect platelets, including accelerating platelet clearance, inhibiting platelet production, inducing platelet killing and interfering with platelet function. This is shown on Slide 17.

By eliminating and degrading those pathogenic autoantibodies, efgartigimod also takes a multimodal approach. This may be a key differentiator for efgartigimod compared to current therapeutic options, which can address just one of these modes of action.

Our belief is that efgartigimod could play across the patient population as an add-on therapy to the existing treatment modalities. The top line data from the Phase II proof of concept ITP trial are on track to read out by the end of the third quarter. The study design is shown on Slide 18.

The aim was to enroll 36 patients who will receive 4 weekly doses of either 5 or 10 milligram per kilogram efgartigimod or placebo and then be monitored during a 21-week follow-up period. You'll also recall that we amended the trial earlier this year to include an auto-enable retreatment arm for 1 year at the higher dose of 10 milligram per kilogram.

The data we expect to provide this quarter will be from all patients through the 21-week follow-up and will include safety and tolerability results, the primary endpoint, and data on platelet counts, the need for rescue therapy, and number of bleeding events. Similarly, we aim to correlate clinical response with the pharmacodynamic effect.

The complete data set will be presented during our annual workshop around the American Society of Hematology or ASH Annual Meeting in December.

Before turning the call over to Eric for financials, I'd like to briefly touch on our argenx long-term program, our current collaborations and our ongoing Innovative Access Program, which has proven to be very productive in creating new valuable assets in our pipeline.

On Slide 19, you'll see the development plan for ARGX-110, which is our lead oncology asset against the novel target, CD70. In B and T-cell malignancies, the CD70, CD27 pathway is permanently activated, causing the proliferation and survival of tumor cells.

By blocking the CD70 and CD27 interaction, we have shown an ability to block the tumor growth signal, enhance ADCC-mediated cell killing and restore immune surveillance.

We had encouraging data from our Phase I/II in CTCL and early data last year at ASH in AML showed that when you block the CD70, CD27 path, leukemic stem cells revert to normal myeloid differentiation.

With this strong data set and given the current therapeutic landscape, we decided to prioritize the AML program, which we transitioned into Phase II earlier this year.

With regards to next steps, we expect to present data from the full Phase I/II dose escalation of ARGX-110 in AML at the ASH conference this year and will include response rate and duration of responses from all 4 dose cohorts.

Additionally, this quarter, we have success milestones from all 3 of our ongoing collaborations, triggering payments to argenx. We can see these highlighted on Slide 20. The first from LEO Pharma following the approval of a CTA for ARGX-112.

And the second from AbbVie, after crossing the second and final pre-clinical hurdle for ARGX-115, which is further explored on Slide 21. AbbVie will not have the opportunity to exercise its option to in-license and the development and commercial rights to the compound.

Finally, we also have reached a preclinical milestone in our strategic collaboration with Shire. This milestone was triggered by Shire exercising its exclusive option to in-license an antibody discovered and developed using the company's proprietary SIMPLE Antibody platform and Fc engineering technologies.

ARGX-112 and ARGX-115 were identified through our Innovative Access Program, a productive engine through which we continue to combine our growing leadership as antibody specialists with leading disease biology experts namely academic labs or small biopharma companies that have deep research expertise on a specific target.

In case of ARGX-112, that expertise involves IL-22 receptors and skin inflammation disorders from the Ludwig Institute. In case of ARGX-115, the expertise from the de Duve Institute involves the novel immune checkpoints targets called GARP.

Our pipeline also consist of ARGX-109, which we partnered with Genor Pharma in China and ARGX-116, which we partnered with Staten Bio to develop an anti-APOC3 for dyslipidemia. We expect our Innovative Access Program to be a key driver behind our pipeline growth.

We have a range of pre-clinical assets that may involve into future partnerships or collaborations or may evolve to become wholly owned argenx assets that we will take forward ourselves. We have announced the early development of ARGX-117 which is a novel target in the complement cascades, and expect to announce details on ARGX-118 later this year.

I'd now like to turn up the call over to our CFO, Eric Castaldi, for him to walk through the financials..

Thank you, Tim. So let's move to Slide 23. Our half year operating results are detailed in this morning's press release and filed with the requisite exchange agencies. Total operating income was €20.5 million for the 6 months ended June 30, 2018, compared to $23.9 million for the same period in 2017.

The difference in operating income between the 2 period was driven primarily by reduced revenues in relation with the completion of the pre-clinical activities under our ongoing collaboration with LEO Pharma.

Research and development expenses amounted to €34.4 million for the 6 months ended June 30, 2018, compared to €25.6 million for the same period in 2017.

The increase in R&D expenses in 2018 was principally due to an increase of €4.4 million in share-based compensation expense linked to the grant of stock options to our R&D employees, an increase of €4 million in costs related to the advancement of the clinical equipment and manufacturing activities of ARGX-113 and ARGX-110.

And also costs associated with the planned increase in research and development headcount. SG&A expenses totaled $11.5 million for the 6 months period ended June 30, 2018, compared to $5 million for the same period in 2017.

The increase in 2018 is mainly due to an increase of $4.5 million in share-based compensation expense linked to the grant of stock options to our SG&A employees and total equipment of additional employees not only in our U.S. office to further strengthen our SG&A activities in order to support the growth as next stage clinical company.

The company generated a total comprehensive loss of €20.1 million in the first half of 2018 compared to a loss of $8.2 million during the same period last year. Our cash position, including our cash, cash equivalents and current financial assets as of June 30, 2018, was €338.9 million compared to €173.4 million on June 30, 2017.

The significant increase in our cash position resulted from our public offering in December 2017. Moving to the Slide 24. This slide shows that so far, we have been highly efficient in managing our capital.

Since inception, we have raised a total of €475 million of capital, including the proceeds from our NASDAQ IPO in May 2017 and our follow-on offering in December 2017. At the end of June, we have employed 108 people of which 80 were in R&D and 28 in SG&A.

With our cash position, we continue to believe that we are well capitalized to execute on our strategic plan. Our burn rate is expected to increase significantly as we advance our clinical development pipeline. In parallel, we will also advance and expand our pre-clinical product pipeline looking to access novel targets and technologies.

To complete on this financial slide, you can see the fully diluted shareholding structure of argenx as of June 30, 2018. Through our 2 public offerings in 2017, we have now a free float of almost 87%, with U.S. institutional investors comprising over 70% of our shareholder base. And now, I will turn the call back to Tim..

Thank you, Erik. Look, we're very excited by all of our focus this past quarter highlighting the broad potential of our lead asset, efgartigimod, as a pipeline of product opportunity.

This includes Phase II data in 2 indications, myasthenia gravis and pemphigus vulgaris, showcasing the breadth of inhibiting FcRn in severe autoimmune diseases; the productive meeting we held with the FDA and feedback on our planned pivotal Phase III program; and the viability of the subcutaneous formulation of efgartigimod.

We are moving forward across the efgartigimod program and have the following upcoming milestones. We expect to report Phase II proof of concept data in ITP before the end of the third quarter, and then the full data set around ASH in December. We expect to launch the Phase III pivotal trial in MG before the end of this year.

We expect to report data from the second and third cohorts in PV during the first half of 2019. We expect to continue to explore potential dosing schedules with our subcu product candidates and determine how to best move forward into clinical trials and ultimately, commercial use if approved.

We remain focused on our data pipeline and expect to report the dose escalation data of ARGX-110 from our Phase I AML cohorts around ASH and continue enrolling the Phase II parts.

We are confident in our ability to advance and grow our pipeline, taking assets against novel targets that stem from our SIMPLE Antibody platform and collaborations with leading researchers and moving them swiftly forward to the clinics to expand our leadership as antibody specialists.

And with that, we'd now like to open the call for questions and answers.

Operator?.

[Operator Instructions] We will now take our first question from Yatin Suneja from SunTrust. Please go ahead..

Maybe I'll start with the AA-MG trial, the planned Phase III.

Could you tell us what the dosing frequency might be? Have you disclosed the powering assumption or how have you used the Phase II to come to the powering assumption, specifically with regard to the placebo arm? And finally, on that trial, can you confirm the autoantibody negative patient that you will be enrolling in the trial, they are not part of the statistical plan.

And then I have a question on ITP afterwards..

It is true that specific details of the trial design like the dosing, the powering, et cetera, has not been disclosed yet, and I would like to hold off addressing that question until the details have been made public. We're likely going to make details public when we launch the Phase III clinical trial.

I can confirm to you that although we are including patients with autoantibodies against different components of the neuromuscular junction than the acetylcholine receptors, that we will not be dependent on these patients to achieve statistical significance in this clinical trial..

Now with regard to the ITP trial, can you help us understand what the bar there is for success? I mean, obviously, there is a competitor that has shown response rate in the 30-plus percent range? So what data set are you looking at that would compel you to move forward? So that's just one part of the question.

And then just a broader question on the ITP, if you can maybe help us understand the positioning of your drug a little better relative to IVIG, maybe talk about the importance of fast onset of action, how critical that is, and/or is it durability that drives physicians' interest?.

So in ITP, if you want to compare, of course, data across clinical trials, we have to make sure we compare apples with apples. So I think the devil is in the detail of how people define response, and you see the different players have defined response in slightly different ways. In our breakfast symposium with Dr.

Broome, actually we have presented a slide with 2 accepted definitions on what a platelet response constitutes. Now just for the sake of clarity, we will be releasing the full platelet count data on our top line data so that everybody can look at these curves and decide for him or her what type of definition you would like to apply.

Now where is that the bar for success? If you look at the products today, you will see anything between, roughly speaking, 18% and 50%, and we have seen very recently an approval for sunitinib with an 18% response, very broad label.

And we have seen in the past, the TPO receptor agonist with short-term response of, let's say, 15% to 50%, but long-term response, we all know that it's around 40%. So I would say, that the bar of success is between 18% and 50%. The real question is also, of course, durability of response. And that goes to your second question, specifically in ITP.

IVIG is really niched into rescue therapy. The onset of action of IVIG is fast. I think it's one of the fastest therapies out there. It's a matter of days to restore platelet counts. But we also know that IVIG is losing its effect really fast. So IVIG can only be used as kind of rescue therapy in an ITP setting.

It's not really used in a maintenance setting. I think there, we need to look more at the TPO receptor agonist. So speed of onset of action is important. But I think what we hear from physicians and patients is that in the first place, response is important and durability of response.

That is what people are really waiting for, and let's also not forget that the safety profile of the current medication is pretty brutal. So people are looking for safe, efficacious medication..

I have a question for Eric on the P&L side. Maybe can you help us model the R&D on your data going forward? We saw an uptick in Q2. Is that a good proxy for rest of the year? And could you also tell us what was the weighted number of share outstanding, either for the quarter or for the first half of the year, so that we can calculate the EPS..

I mean, we're going to see a significant increase in our R&D expenses as we move forward. And that will be when we're going to enter into Phase III, obviously, this year. So we expect our cost rate to increase moving forward.

We had even a guideline and now that we have received the payment from AbbVie, the $10 million, so the new guidelines for development is between $70 million to €75 million for the year. And regarding the number of shares, just one sec, I can't tell you immediately, so it is 32,442,864 average.

So it's the weighted average, yes, for the Q2 2018, 32,442,864..

We will now take the next question from Jason Butler from JMP Securities. Please go ahead..

I have two.

First of all, just thinking about the open label retreatment P trial versus the changes you made in the maintenance phase now on the PV trial, do you think that you're coming to a convergence of long-term repeat duration or thinking to roll this? Is this something you're going to continue to meet with the traditional and functionally, you look at.

And then second question, could you maybe talk a little bit more about how you see the integration of the subcu formulation into the development program? Could we start to see this built into the ongoing trials or the label extensions? Or a new set of trials we should be thinking about in the future?.

Yes, so regarding your first question, Jason, this is an excellent question. I think it's too early to say whether we see convergence between different disease indications. We would need to look at the ITP data when they become available in September. We need to learn more about PV. But as a general rule, I would be very careful doing that.

Myasthenia gravis is a disease in the muscle, at the neuromuscular junction. ITP is a disease, which plays in the blood compartment and the bone morrow compartment and pemphigus is a disease which plays in the skin compartment. And therefore, I believe that the longer-term dosing considerations for all 3 indications could be different.

So we're learning across different indications, we need more data. But today, I would shy away from just blindly extrapolating from one indication to the other indication. Concerning your question in the subcu product, we're very excited about the subcu opportunity. We're certainly going to push it forward into later clinical development.

What we have said today is that it's unlikely that we're going to do that in myasthenia gravis first. Myasthenia gravis, we believe, is an indication where we can go-to-market with an IV product first. But for sure, we will want to flank the IV product to the subcu product going forward.

So expect in the future announcements on further clinical work where we will actually advance subcu to market..

We will now take our next question from Boris Peaker from Cowen. Please go ahead..

I'll start the move for the MG pivotal study, I'm just curious, how long do you anticipate the enrollment to take?.

This is an excellent question. We don't know, of course. The only thing we can do is we can look at precedents. And I would say that the REGAIN trial is an interesting proxy. The REGAIN trial performed by Alexion, where they enrolled 125 patients, took them about 22 months.

I think we are enrolling in a broader patient population, not just the refractory patients, but we're enrolling more patients, 150. So based on everything we know today, I think the 22 months would be a good proxy for the duration of the study..

And before you commence the study, are you waiting on any competitor data to inform your thoughts or decision or is it fully developed and irrespective of any competitor data that might come to market?.

Correct. So we believe that we're ahead of the pack in MG, so we'll be not waiting for anybody else's data. Our strategy is speed to market, so basically, the time line is driven by internal clinical operation considerations..

So a quick question on the subcu formulation.

What's the injection volume?.

So the 300 milligram, which we have been applying in this Phase I study is sitting in a volume of 2 milliliters, that is pretty exciting because you have off-the-shelf systems with good patient acceptance in that order of magnitude, 2 milliliters, 2.5 milliliters.

For example, ipilimumab from Sanofi-Regeneron, is an antibody with a very well accepted user profile. It's a subcu product, which is sitting at 2.5-milliliter volume, dosed in a subcu injection. So the 300 milligram nicely fits into a 2 ml volume..

And my last question, on 110, can you comment specifically how many patients worth of data we should we be expecting at ASH?.

We would get 12 patients worth of data because we have not seen any dose-limiting toxicity, so we follow the classical 3 plus 3 design, that means you have 3 patients for each of the 4 dose cohorts..

We will now take our next question from Ted Tenthoff of Piper Jaffray. Please go ahead..

So a lot of questions answered here looking for the ITP data in the Phase III trial side. I wanted to come back to PV and sort of get a better sense of what next steps are there and how you'll kind of figure out past towards a registration trial..

Ted. I think we need to continue enrolling cohort II and cohort III and learn. So we need to learn what the performance profile is of this drug in this specific indication. What we learned is that we can knock down the pathogenic IgGs in exactly the expected fashion.

The IgG follow down a curve -- follows exactly the IgG fall and down curve from the healthy volunteers in the MG patients. The big surprise in the study so far has been the fast onset of action. Experts find it intriguing that within 1 week we achieved disease control in 3 other sick patients and in 4 -- in the 4 patients within the first month.

Now that is something which is very valuable in this indication because PV, of course, is a barrier defecet. I mean, you have a massive barrier defect exposing you to a higher rate of infection and also high mortality due to infection.

So stopping formation of new lesions and closing existing lesions is very valuable, especially knowing that today rituximab has a very slow onset of action. It takes about 3 to 4 months for rituximab to start to show activity. And still, the relapse rates on rituximab continues to be high.

So I think we're unraveling and learning about the strengths of the molecule and we should be patient and wait for these data until we can craft then the Phase III design in function of the proper positioning in these compelling markets..

Right. That makes a lot of sense.

And then just I know a lot of people are asking about this, but when could we expect to hear more about the target and sort of development plan for 117?.

There is a plan to organize an R&D Day in the first half of next year, and I think the purpose of the R&D Day amongst all this will be to give a deeper view or a more thorough view into the upstream part of the pipeline.

So you can expect during that R&D day that we will be disclosing quite a few data on the more upstream assets, including ARGX-117, but probably also ARGX-118. We said today that we will communicate about ARGX-118 later this year..

We will now take our next question from Chris Parrish from Nomura. Please go ahead..

I was wondering if you could take a look at -- or could help understand your path forward at MG. AbbVie is enrolling MG or most patients, and those patients might be expected to benefit disproportionately from your drug. And have you looked at perhaps stratifying enrollment and perhaps your path to approval in some populations of MG.

And then I've got a follow-up..

So I think the expected thing about the global registration trial which we're about to roll out is that we are going to enroll all generalized MG patients regardless of the type of autoantibody.

So the study is really designed and powered around the acetylcholine receptor-positive patients that we had a constructive discussion with the FDA how we would go about the other patients which are, by the way, in even bigger medical need because nobody developing a drug for these patients.

So I think we will try to test them all in 1 trial and then enter the discussion again with the FDA once we have the submission file in hand. So the idea would be to go for broad label in generalized MG patients. Basically, those patients, which are inadequately controlled by the standard of care. So it's a pretty ambitious target..

Understood. So it sounds to me like there might be a possibility based on your trial design to also win in-construct populations if the broad -- if the efficacy in the broad population doesn't hold up to what our expectations currently are.

Is that a correct assumption?.

This is what I said, Chris. What I said is that the heart of the study consist of the acetylcholine receptor autoantibody positive patients and we're kind of adding on the other patients as an extra, as a bonus. But the study will basically pivot on success in the acetylcholine receptor-positive patients.

Is that sufficient for you?.

And then, just - yes, no, that's clear.

And then just with respect to, I guess, the other indications for the drug, any possibility that this -- that this drug, 113, could be approved on other indications here or ITP or others to the MG Phase III readout?.

We will be concentrating in our strategy. What we always said is that success in the beachhead indication means that we can now start to open up that space and start to add indications and try to build a franchise. We have strong data in myasthenia gravis.

So we are currently examining additional possible indications in the neuromuscular space, just like we will do that in the heme space in case we have positive ITP data. So the 3 beachhead indications are just the start. We are actively exploring possible additional indications..

[Operator Instructions] We will now take our next question from Sandra Cauwenberghs from KBC Securities. Please go ahead..

I have four small questions left on ARGX-117. So I understand we'll get more information on the R&D Update Day.

But is it possible to give us a bit more with regard to when a possible Phase III could -- sorry, a Phase I could start? So is that possible early next year? With regard to ARGX-110, I had understood that this could be up for partnering at the end of the Phase II.

So is this possible by year-end '19? A quick update on potential milestone payment that we could still expect in the second half of this year would be interesting and into 2019.

And then with regard to the headcount increase with regard to R&D and administrative staff, so we got an update on the amount of staff that was hired, but could you elaborate on how many people you foresee to hire in the second half of '18 and the first half of '19?.

So with regard to ARGX-117, when we launched the program, we said we were about 18 months away from clinic. So that means that an IND filing would rather happen towards the end of 2019, not towards the beginning. For ARGX-110, yes, it is true that we said that we would continue to execute the Phase II study as fast as we can on a stand-alone scenario.

We also need to aim for an interaction with FDA on the regulatory path going forward in a registration file. And I think the Phase II data and the FDA interaction will guide us as a company in our decision-making whether we embark on a Phase III alone or whether we would look for strategic partnership on the molecules.

I would say, stay with us whilst we navigate through data and FDA interaction, and we will certainly be happy to give updates during the course of the next years. With regard to milestone payments expected, I have to be short. We only allow them at our deals to talk about milestone payments if and when they happen.

So we will certainly actively communicate about them. We have explained in the past what expected payments could be under the LEO collaboration, under an AbbVie collaboration, under a Shire collaboration. So any of these payments actually are possible, but we can only communicate if and when they happen.

And with regard to headcount increase, it is clear, of course, that this company needs to scale. We have created quite a bit of optionality in our programs and in our pipeline.

It turns out, of course, that most of the options continue to yield outstanding data and that means that if we want to credibly develop, then we will need to grow as an organization. As Eric explained, we're currently with a headcount of 108 people.

With this type of pipeline, I can tell you that most of our peers are actually running with headcounts, which are double or triple of our headcount. So we will need to invest in capacity and bandwidth, and you will see a rather aggressive move on the recruitment front in the next year.

So I don't think it's unrealistic, that this company will add 50% to 75% extra headcount in the next year to come..

We will now take our next question from [indiscernible]. Please go ahead..

I wanted to go further on the AML trial with 110. You mentioned in the press release and a couple of times before that you expect to go forward there with the 10 milligram dose.

As you've seen no dose-limiting toxicity in the different cohorts, do you expect that you could even go to the 20 milligrams? Is that a possibility still at this time?.

So doses have been a key question in this Phase I because we saw efficacy across the doses. We didn't see any dose-limiting toxicity, so how did we pick the 10 milligram per kilogram dose for the Phase II? Well, we did it based on the bone marrow PK assay.

So we do know that distribution of therapeutic antibodies in the bone marrow compartment can differ fundamentally from the distribution in the circulation. And therefore, we collected bone marrow data, convincing us that at 10 milligram per kilogram, we achieve full saturation of the target at bone marrow level.

So the target saturation in the bone marrow has been our guiding factor to determine to go for a 10 milligram per kilogram dose in the ongoing Phase II study. [Abrupt end].