Half Year 2020 argenx SE Earnings Call

July 30, 2020

[music].

Operator: Welcome to argenx H1 2020 financial results and Q2 business update conference call. At this time, all participants are in listen-only mode. To follow the presentation, we ask that you navigate the slides as directed by argenx management. There will be a question and answer session to follow. I would now like to hand the conference over to Ms. Beth DelGiacco, Vice President of Investor Relations at argenx. Thank you.

Bump you all Jonah field.

She let's say 20 financial results I Buck imports of business update conference call.

All participants are in listen only mode before the production base, we ask that you navigate this like after I guess like our Jamex management.

Bill Washington, It onto sessions to follow all of them back partner conference over to that so Jack on Vice President Gulf Investor Relations targets. Thank you.

Thank you a press release was issued earlier today with our half year 2020 financial results in second quarter business update.

Beth DelGiacco: Thank you. A press release was issued earlier today with our H1 2020 financial results and Q2 business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, 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 those statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer, Keith Woods, Chief Operating Officer, and Eric Castaldi, Chief Financial Officer. On slide three, you can see our agenda.

Operator: , Arjen Arjen Arjen Arjen Arjen Arjen Arjen Arjen Arjen Arjen Arjen Arjen Arjen Arjen At this time, all participants are in listen-only mode. To follow the presentation, we ask that you navigate the slides as directed by ArgenX. There will be a question and answer session to follow. I would like to have a conference over. Beth DelGiacco, Vice President of Investor Relations at ArgenX. Thank you.

This can be found on our website along with the presentation for today's webcast before we begin I'd like to remind you on slide two that forward looking statements may be presented during this call. These may include statements about our future expectations clinical development 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 are Josh is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law.

Beth DelGiacco: A press release was issued earlier today with our half-year 2020 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you, on slide 2, that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timelines, potential success of our product candidates, financial projections, and upcoming milestones. However, 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 those statements in relation to actual results unless required by law.

I'm joined on the call today by to embed Howard Chief Executive Officer, Keith Woods, Chief operating Officer, and Air consolidate Chief Financial Officer.

On slide three you can see our agenda, Tim will be highlighting recent milestones, including the positive phase <unk> adapt data.

Beth DelGiacco: Tim will be highlighting recent milestones, including the positive Phase 3 ADAPT data we reported in May and the progress we've made in our ongoing efgartigimod programs and additional indications. We announced a change in our development plan for cusatuzumab this morning, and Tim will update you on the reasons for that shift in strategy. He will close with an update on our earlier stage programs, including those that are wholly owned and partnered. Keith will then provide an update on our commercial preparation, and Eric will share our financial results. We'll then close with a Q&A session. I will now turn the call over to Tim.

Imported in Bay and the progress we've made our ongoing ask or kick them off programs and additional indications we announced a change in our development plans, which was the to have this morning, and Tim will update you on the reason for that shift in strategy and he will close with an update on our earlier stage programs, including those that are wholly owned and partner piece will then provide an update on our commercial preparation and Eric.

Beth DelGiacco: I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer, Keith Woods, Chief Operating Officer, and Erica Salde, Chief Financial Officer. On slide 3, you can see our agenda. Tim will be highlighting recent milestones, including the positive results in the ADAPT data we reported in May, and the progress we've made in our ongoing ESCR TIGMOD programs and additional indications. We announced a change in our development plan for Kusutuznov this morning, and Tim will update you on the reasons for that shift in strategy. And he will close with an update on our earlier stage programs, including those that are wholly owned and partnered. Keith will then provide an update on our commercial preparation, and Eric will share our financial results. We will then close with a Q&A session. I will now turn the call over to Tim.

Sure our financial results I'll, then close with acuity session.

I'll now turn the call over to Tim.

Thank you Beth and welcome everyone. We appreciate you joining the call today.

Tim Van Hauwermeiren: Thank you, Beth, and welcome everyone. We appreciate you joining the call today. We're now almost six months into what we can only continue to describe as unprecedented times. I hope you and your families are staying safe and healthy. At argenx, we have been opening our Ghent offices on a restricted basis as we watch the data on the number of coronavirus cases in Belgium. We continue to keep our work from home mandate in the US and Japan. Throughout this virtual work environment, our team has kept to its high work standards to minimize disruptions to our business as best as possible. For this, I must share my gratitude to the entire team in navigating this new normal.

We now almost six smoke into what would be kind of oil and continued to describe as opposed to the problems I hope you and your families have seen safe and healthy.

Electronics, we hope in opening I would guess offices only to stick to the basis.

As we watch the data on the number of grown up artists cases in Belgium.

Continued to keep up her work from home mandate in the U.S. in Japan.

Tim Van Hauwermeiren: Thank you, Beth, and welcome, everyone. We appreciate you joining us on the call today. We're now almost six months into what we can only continue to describe as unprecedented times. I hope you and your families are staying safe and healthy. At ArgenX, we have been opening our GAN offices on a restricted basis as we watch the data on the number of coronavirus cases in Belgium. Meanwhile, we continue to keep our work from home mandate in the US and Japan.

Throughout this virtual work environments.

Our team has got to its hard work standards to minimize disruptions to our business as best as possible.

For this I must share my gratitude to the buyer team in navigating this new enrollment.

On slide four.

Tim Van Hauwermeiren: On slide four, I would like to highlight some of the significant milestones we have achieved virtually as a team, all of which will be covered in more detail later in the call. We executed a key Phase 3 data disclosure with a top-line readout of our ADAPT trial, including a subsequent financing to support our first commercial launch and the advancement of our differentiated pipelines. The data from ADAPT showed that efgartigimod has a promising therapeutic profile with robust efficacy, and tolerability, and the potential to offer individualized dosing to patients. These results, along with our having enrolled ADAPT ahead of schedule, have further strengthened our leadership position among FcRn antagonists. We have also worked hard to stay on track with the filing of our BLA to the FDA, expected by the end of the year, and our filing in Japan in early 2021.

I would like to highlight some of that significant milestones we have achieved Conversely, as a team all of which will be called in more detail later in the call.

We executed a PC because its closure.

Tim Van Hauwermeiren: Throughout this virtual work environment, our team has kept to its high work standards to minimize disruptions to our business as best as possible. For this, I must share my gratitude to the entire team for navigating this new normal. On slide four, I would like to highlight some of the significant milestones we have achieved virtually as a team, all of which will be covered in more detail later in the call. We executed a key phase 3 data disclosure with the top-line readout of our ADAPT trial, including subsequent financing to support our first commercial launch and the advancement of our differentiated pipeline. The data from ADAPT showed that Avgab Digimod has a promising therapeutic profile with robust efficacy and tolerability and the potential to offer individualized dosing to patients. D'souza, along with our having enrolled Adept ahead of schedule, has further strengthened our leadership position among SGRN antagonists. We have also worked hard to stay on track with the filing of our BLA to the FDA expected by the end of the year and our filing in Japan in early 2021. Is that a plus?

With the bulk buys read out of our adapt trial, including is such a good financing to support our first commercial launch and the advancement of our differentiated pipeline.

The data from a data showed that I've got pick them up has a promising therapeutic profile with robust efficacy and tolerability and the potential to offer individualized dosing to patients.

These results along with Albert having enrolled but that's the head of space.

Further strengthens our leadership position among at CIT antagonists.

We have also wrote hard to stay on track with the filing or proverbial late to the 78 expected by the end over to you and other filing in Japan in early Twentytwenty wall.

Tim Van Hauwermeiren: The ADAPT Plus, our long-term open label extension study, has had a high retention rate and continues to provide us the safety data we need for our regulatory filings. Our clinical operations team has been able to open new trial sites at an impressive pace during the last few months, including those for our ITP and CIDP trials. We have implemented important measures into these trials to adapt to social distancing requirements and the challenges patients face in visiting sites in person. We quickly enabled our ARGX-117 complement inhibitors to be studied in COVID patients. We will continue to be nimble should a second wave of the virus come to Belgium. We are also ready to start our planned phase I trial of our ARGX-117 in healthy volunteers any day.

But the close our long term open label extension study has had a high retention rate.

And continues to provide us the safety data, we need for all the regulatory filing.

Our clinical operations team has been able to open new trials sites as an impressive space during the last few months, including goals for our IP B and C IBP trial.

We have implemented important measures.

These trials to adapt to social distancing requirements.

Tim Van Hauwermeiren: Our long-term open-label extension study has had a high retention rate and continues to provide us with the safety data we need for our regulatory filing. Additionally, our clinical operations team has been able to open new trial sites at an impressive pace during the last few months, including those for our ITP and CIDP trials. We have implemented important measures into these trials to adapt to social distancing requirements and the challenges patients face in visiting sites in person. We quickly enabled our argenix-117 complement inhibitors to be studied in COVID patients and will continue to be nimble should a second wave of the virus come to Belgium. We are also ready to start our planned phase 1 trial of ArgenX 117 in healthy volunteers any time. Throughout the last six months, we have been able to maintain all lab activities by creating a safe work environment for these essential employees. This has allowed us to keep our discovery efforts on track. And finally...

And the challenges patients face.

The thing sites in person.

We quickly enables our Jennings from 17 complement inhibitors to be studied in corporate patients and we'll continue to to be nimble should a second wave over the prior to scope to Belgium.

We are also ready to stop our planned phase one trial of objects from 17 in healthy volunteers any day.

Throughout the last six months, we have been able to maintain all other activities by creating a safe broken environment for these essential employees.

Tim Van Hauwermeiren: Throughout the last six months, we have been able to maintain all lab activities by creating a safe work environment for these essential employees. This has allowed us to keep discovery efforts on track. Finally, the positive Phase 3 ADAPT data readout was a key gating event for us to accelerate our transformation into a commercial organization. This includes the ongoing expansion of our team to prepare for the anticipated US and Japan launches of efgartigimod. We have been fortunate to make a lot of excellent hires recently. Of course, our increasing commitment to the physician and patient communities has remained a top priority during this time through virtual engagement. Slide 5.

This has allowed us to keep discovery efforts on track.

And finally.

The positive phase to get that data readout was a key gating event for us to accelerate our transformation into a commercial organization.

This includes the ongoing expansion of our team to prepare for the anticipated the U.S. in Japan launches of I've got picked them up.

We have been fortunate to make a lot of excellent highest recently.

And of course are increasing commitment to the physician and patient community has remained his top priority. During this time through virtual engagement.

Tim Van Hauwermeiren: The positive Phase 3 ADAPT data readout was a key gating event for us to accelerate our transformation into a commercial organization. This includes the ongoing expansion of our team to prepare for the anticipated U.S. and Japan launches of AVGAR TIGEMOM. We have been fortunate to make a lot of excellent hires recently.

Slide five.

Before I transition to the rest of our business update I'd like to say that while corporate my team has presented a multitude of new challenges over the past pmone.

Tim Van Hauwermeiren: Before I transition to the rest of our business update, I'd like to say that while COVID-19 has presented a multitude of new challenges over the past few months, we continue to demonstrate our functional agility to adapt as needed. We will not be a company that accepts delays without finding ways to think and work differently and to combat the unforeseen obstacles we are facing. We remain sharply focused on executing our 2021 vision to be a fully integrated immunology company. This is driven by preparing for the successful launch of our first product, executing on our differentiated pipeline of early and late-stage development programs, and building out our pipeline through our immunology innovation program, which is on track to yield our ARGX-119 later this year. This will be our 10th pipeline asset that is either wholly owned or in the hands of a partner.

We continue to demonstrate our functional agility to adapt as needed.

We will not be a company that accepts delays without finding ways to think and work differently and to combat the unforeseen obstacles we are facing.

Tim Van Hauwermeiren: And, of course, our increasing commitment to the physician and patient communities has remained a top priority during this time through virtual engagement, slide 5 Before I transition to the rest of our business update, I'd like to say that while COVID-19 has presented a multitude of new challenges over the past few months, we continue to demonstrate our functional agility to adapt as needed. We will not be a company that accepts delays without finding ways to think and work differently and to combat the unforeseen obstacles we are facing. We remain sharply focused on executing our 2021 vision to be a fully integrated immunology company. This is driven by preparing for the successful launch of our first product, executing on our differentiated pipeline of early and late stage development programs, and building out our pipeline through our Immunology Innovation Program, which is on track to yield ArgenX-119 later this year. This will be our 10th pipeline asset that is either wholly owned or in the hands of a partner. Let's first talk about Afgha Tigemat, our first-in-class Afghan antagonist.

We remain choppy focused on executing our 2021 vision to be a fully integrated immunology company.

Tim Van Hauwermeiren: Slide 6. In May, we were thrilled to report positive top-line data from the Phase 3 ADAPT trial, which showed that abgartigamot was well-tolerated and able to drive deep responses that support our plan to offer individualized dosing to MG patients. We plan to show the full ADAPT data set later this year at a medical meeting. These meetings are all shifting to virtual and adjusting their programs as necessary, but as soon as we have our confirmed plan, we will share it.

This is driven by prepared and put a successful launch of our first product.

Executing on our differentiated pipeline early or late stage development programs and building out our pipeline through our immunology innovation program, which is on track to use objects from 19 later this year.

This will be our 10th pipeline assets that if either wholly owned or in the hands of Apollo.

Let's first talk about adopting them off our first in class I've said on antagonist.

Tim Van Hauwermeiren: Let's first talk about efgartigimod, our first-in-class FcRn antagonist on slide six. In May, we were thrilled to report positive top-line data from the phase 3 ADAPT trial, which showed that efgartigimod was well-tolerated and able to drive deep responses that support our plan to offer individualized dosing to MG patients. We plan to show the full ADAPT data set later this year at a medical meeting. These meetings are all shifting to virtual and adjusting their programs as necessary, but as soon as we have our confirmed plan, we will share it. To quickly summarize the top-line results on slide seven, ADAPT met its primary endpoint with 67.7% of acetylcholine receptor antibody positive gMG patients, which were responders on the MG ADL score compared with 29.7% on placebo with a P value of less than 0.0001.

On slide six.

In May we were close to report positive topline data from the face the adapt trial, which show that uptick in multiple spoke tolerated and able to drive deeper responses to support our plan to offer individualized those into energy patients.

We plan to show the fullest update us at later this year at a medical meeting.

This meetings are all shifting to virtual and adjusting that programs if necessary, but the soonest, we hit our confirmed plan we will share that.

Quickly summarize the topline results on slide seven.

But thats met its primary endpoint with 67.7% of after a few clean receptor antibody positive Jim GE patients, which grow this focus on the energy it feels core compared with 29.7% on placebo with a P value of less than <unk> 0.00 to one.

We finally have responded as having at least a two point improvement on the MG Aereo score for at least four weeks, we'll for five consecutive measurements.

Tim Van Hauwermeiren: We define a responder as having at least a 2-point improvement on the MG ADL score for at least 4 weeks over 5 consecutive measurements. This was a pretty high bar for the primary endpoint since we included this durability component. We confirmed this efficacy response on the QMG score as well, with 63.1% of antibody-positive patients responding to efgartigimod compared to the 14.1% on placebo on the QMG score, with again a P value of less than 0.0001. To be a responder, patients needed again a 3-point improvement for 5 consecutive measurements. On slide 8, we saw depth of response as measured by minimal symptom expression or reaching an MG ADL of 0 or 1. This is an important measurement for patients and physicians because it means that patients are generally symptom-free.

Tim Van Hauwermeiren: We will quickly summarize the top line results on slide 7. The DAPT met its primary endpoints with 67.7% of acetylcholine receptor antibody-positive GMG patients who were responders on the MG-ADL score compared to 29.7% on placebo with a p-value of less than 0.0001%. We define a responder as having at least a 2-point improvement on the MJ-ARL score for at least 4 weeks or for 5 consecutive measurements. This was a pretty high bar for the primary endpoints since we included this durability component. We confirmed this efficacy response on the QMG score as well, with 63.1% of antibody-positive patients responding to Efgra Trigemats compared to 14.1% on placebo on the QMG score, with again a p-value of less than 0.0001. To be a responder, patients again needed a three-point improvement for five consecutive measurements. On slide eight, we saw depth of response as measured by minimal symptom expression or reaching This is an important measurement for patients and physicians because it means that patients are generally symptom-free.

This was a pretty high bar for the primary endpoint since we included does durability component.

We come from this efficacy of US both on the QFC scored as well with 63.1% of antibody positive patients responding to pick him up compared to the 14.1% on placebo on the Q Mg score with again the P value of less than 0.000 warm.

To be a responder patients speed of began its report improvement for five consecutive measurements.

On slide eight.

We saw best of response as measured by minimal symptom expression or reaching an empty it yell of zero or will.

This is an important measurement for patients and physicians because it means of patients are generally symptom free.

40% of has got seeking a lot fetus antibody positive patients achieved minimum symptom expression compared to 11.1% treated with placebo.

Tim Van Hauwermeiren: 40% of efgartigimod-treated antibody-positive patients achieved minimum symptom expression compared to 11.1% treated with placebo. We also show that patients responded quickly and some for an extended period of time. Of the 44 patients who were efgartigimod responders, 84.1% had a fast response initiated within the first 2 weeks. Additionally, 88.6% of patients who reached the primary endpoint achieved a response for at least 6 weeks, 56.8% for at least 8 weeks, and 34.1% for at least 12 weeks. On slide 9, response rates were consistent during a second treatment cycle of efgartigimod. Remember that 12 patients or 27% who responded in the first cycle never required a second cycle. The start of the second cycle was dependent on the durability of the response in the first cycle.

We also showed that patients responded quickly and some from extended period of time.

Of the 44 patients who were skeptical about responders, 84.1% had a faster response initiated within the first two weeks.

Additionally, 88.6% of patients who reached the primary endpoint achieved the response, but at least six weeks.

Tim Van Hauwermeiren: 40% of adgartigamot-treated antibody-positive patients achieved minimum symptom expression compared to 11.1% treated with placebo. We also show that patients responded quickly and some for an extended period of time in the 44 patients who were Gaptic-Mod Responders. 84.1% had a fast response initiated within the first two weeks. Additionally, 88.6% of patients who reached the primary endpoint achieved a response for at least six weeks. 56.8% for at least 8 weeks and 34.1% for at least 12 weeks on flight nine.

56.8% for at least eight weeks and 34.1% for at least 12 weeks.

On slide nine.

Response rates were consistent joining a second treatment cycle of have got pick them up.

Remember the 12 patients so 27% who responded in the first cycle never required the second cycle.

And the start of the second cycle of dependent on the durability of response in the first cycle.

70.6% of patients who received a second cycle responded.

Tim Van Hauwermeiren: 70.6% of patients who received a second cycle responded, including 36.8% of patients who were not responders in the first cycle. We attribute some of the new responders in the second cycle to the primary endpoint definition. We had several patients that had good responses to efgartigimod in the first cycle but did not meet the high bar of having a clinically meaningful response for five consecutive measurements. We also saw a favorable safety profile that was comparable to placebo, a very high rollover rate from the primary 26-week trial to the long-term open-label extension trial called ADAPT Plus. I would like to contextualize the importance of the ADAPT data readout for our overall efgartigimod strategy. With these strong data, we are looking to disrupt treatment paradigms in autoimmunity.

Including 36.8% of patients who were not responses in the first cycle.

Tim Van Hauwermeiren: Response rates were consistent during a second treatment cycle of Abdapti Gamal. However, remember that 12 patients or 27% who responded in the first cycle never required a second cycle, and the start of the second cycle is dependent on the durability of the response in the first cycle. 70.6% of patients who received a second cycle responded, including 36.8% of patients who did not respond in the first cycle. We attribute some of the new responders in the second cycle to the primary endpoint definition.

We attribute some of the new response in the second cycle to the primary endpoint definition.

We had several patients that had good responses to have got thinking about into first cycle, but did not meet the high bar of having a clinically meaningful response for five consecutive measurements.

We also saw a favorable safety profile that those compatible to placebo.

The very high rollover rate from the primary 26 weeks trial to the long term open label extension trial called plus.

I would like to contextualize the importance of the adept data readouts for our overall have kept thinking about strategy.

Tim Van Hauwermeiren: We had several patients that had good responses to epiglotticum in the first cycle but did not meet the high bar of having a clinically meaningful response for five consecutive measurements. We also saw a favorable safety profile that was comparable to placebo, and a very high rollover rate from the primary 26-week trial to the long-term open-label extension trial, called the plus. I would like to contextualize the importance of the ADAPT data readout for our overall Ad Categorum of Strategy. With these strong data, we are looking to disrupt treatment paradigms in autoimmunity. We know that FCRN is central to IgG regulation.

With these strong data, we're looking to disrupt treatment paradigms in autumn unity.

Tim Van Hauwermeiren: We know that FcRn is central to IgG regulation, so by targeting it, efgartigimod could be a logical new therapeutic option for many patients suffering from autoimmune diseases that are driven by pathogenic autoantibodies. On slide 10, we currently have the broadest FcRn pipeline, evaluating four current indications in three distinct therapeutic areas. We are also planning to announce our fifth indication this year. We expect to have the first FcRn antagonist available to MG patients next year and with this approval, we can start a parallel track of investigator-sponsored trials in indications that may not meet the high bar for a registration program, but where the biology is solidly understood to be driven by pathogenic IgGs.

We noticed FCM is central to our digi regulation, so by targeting it that's cup pick them up could be illogical, new therapeutic option for many patients suffering from auto immune diseases that are driven by pathogenic auto antibodies.

Slide 10.

We currently have the broadest Fcs and pipeline evaluating for current indications in three distinct therapeutic areas.

We're also planning to announce our fixed indication this year.

We expect to have the first FCS and antagonist available to EMG patients next year.

Tim Van Hauwermeiren: So by targeting it, Fgartigamot could be a logical new therapeutic option for many patients suffering from autoimmune diseases that are driven by pathogenic autoantibodies. Slide 10. We currently have the broadest FCNN pipeline, evaluating four current indications in three distinct therapeutic areas. We are also planning to announce our fifth indication this year. We expect to have the first FCNN antagonist available to LG patients next year, and with this approval, we can start a parallel track of investigative sponsored trials in indications that may not meet the high bar for a registration program but where the biology is solidly understood to be driven by pathogenic IgG. The ADAPT readout was a gating event to proceed full steam ahead in the preparation for our first commercial launch, the expansion of our commercial team, With that, I would like to shift to our ongoing EFGATI GAMO trials and those that will start this year. Slide 11.

And with this approval we can stop if parallel track of investigator sponsored trials in indications that may not meet the high bar for registration program, but where the biology solidly understood to be driven by pathogenic IBG.

The adapt to read out was a gating event to proceed full steam ahead in the preparation for our first commercial launch the expansion of our commercial team and in our longer term planning to get picked them up to all the autoimmune patients as quickly as possible.

Tim Van Hauwermeiren: The ADAPT readout was a gating event to proceed full steam ahead in the preparation for our first commercial launch, the expansion of our commercial team, and in our longer-term planning to get efgartigimod to other autoimmune patients as quickly as possible. With that, I would like to shift to our ongoing efgartigimod trials and those that will start this year. Slide 11. It is a top corporate priority to mitigate disruptions from COVID-19, which are now impacting our ongoing trials. To do this, we have focused on several initiatives for the ADAPT+ open-label extension trial in MG and our ADVANCE and ADHERE programs in ITP and CIDP, where we have faced enrollment delays. First, we are integrating telemedicine into clinical trial protocols where possible. We are also implementing home infusion opportunities for patients who do not feel comfortable traveling to infusion centers.

With that I would like to shift our ongoing of caustic them up files and those that can start this year.

Slide 11.

It is a top corporate priority to mitigate disruptions from corporate 19, which are now impacting our ongoing trials.

To do this we have focused on several initiatives for the adept plus open label extension trial LNG.

And our advance and adhere programs in IP and see IDBD, where we have faced enrollment delays.

First we are integrating telemedicine into clinical trial protocols where possible.

Tim Van Hauwermeiren: It is a top corporate priority to mitigate disruptions from COVID-19, which are now impacting our ongoing trials. To do this, we have focused on several initiatives for the ADAPT Plus Open Label Extension Trial in MG and our advance and adhere programs in ITP and CIDP, where we have faced enrollment delays. First, we are integrating telemedicine into clinical trial protocols where possible. We are also implementing home infusion opportunities for patients who do not feel comfortable traveling to infusion centers.

We're also implementing home infusion opportunities for patients, who do not feel comfortable traveling to infusion centers.

Tim Van Hauwermeiren: Finally, we are working to prioritize subcutaneous efgartigimod. We're using the subcutaneous formulation in the ADHERE CIDP trial and will be implementing sub-Q into ITP as well this year. We'd like to update you on our ongoing clinical trials. In the ADAPT Plus open-label extension trial, 133 MG patients remain on study. While we cannot yet quantify the enrollment delays in the ADVANCE or ADHERE programs, we have been pleased with our progress in opening clinical trial sites virtually for both. We have opened ADVANCE 2 for enrollment, but are also in active dialogue with the FDA to assess how best to bring sub-Q to the forefront in the ITP Phase 3 program. With CIDP, we now expect the go/no-go decision to be a 2021 event.

And finally, we are working to prioritize subcutaneous adapting a month.

We are using to subcutaneous formulation in the adhesives, CDP trial, and there will be implementing subcu into IP as well this year.

We'd like to update you on our ongoing clinical trials.

Indeed that plus open label extension trial 133 Mg patients remain on study.

While we cannot yet quantify the enrollment delays in the advance auto key programs. We have been pleased with our progress in opening clinical trial sites virtually.

Tim Van Hauwermeiren: And finally, we are working to prioritize subcutaneous adgartegamol. We're using the subcutaneous formulation in the ADHEAR-CIDP trial, and we'll be implementing SubQ into ITP as well this year. We'd like to update you on our ongoing clinical trials. In the ADAPT Plus Open Label Extension Trial, 133 MG patients remain unstudied. While we cannot yet quantify the enrollment delays in the ADVANCE or ADHEAR programs, we have been pleased with our progress in opening clinical trial sites, virtually, for both. We have open advanced two-front enrollments but are also in active dialogue with the FDA to assess how best to bring sub-Q to the forefront in the ITP-VST program. With CIDP, we now expect the GoNoGo decision to be a 2021 event.

Football.

We have opened advance to for enrollment.

But also an active dialogue with FDA to assess how best to bring sub Q2, the forefront in the Itps T program.

We see I'd Pete we now expect to go no go decision to be Twentytwenty Vantiv and.

Tim Van Hauwermeiren: This will happen after the first 30 patients get through part A in the trial, and we see if they have response to efgartigimod. Remember that in ADHERE, there is a long screening period to ensure we are getting active CIDP patients. We think this disciplined trial design will pay off in getting the right patients to receive efgartigimod and to assess the percent of patients whose disease is antibody-mediated. CIDP is also the first trial in which we are evaluating the sub-Q efgartigimod that emerged from our collaboration with Halozyme. This collaboration has turned out to be a key strategic decision and competitive advantage. Halozyme's enhanced delivery technology is well-validated with a documented safety profile across many biologics. By using this technology, we can achieve at least the same IgG reductions as with the 10 mg per kg IV formulation, and this in a fast, effortless, single sub-Q injection.

This will happen after the first 30 patients get through part eight in the trial and we see if they have a response to of government.

Remember that in a th that is a long screening period to ensure we are getting active share the patients.

We think is disciplined trial design will pay off in getting the right patients to receive uptick in March.

And to assess the percent of patients whose diseases antibody mediated.

Cndp is also the first trial in which we are evaluating the subcu I've got pick him up that emerged from our collaboration with Halozyme.

Tim Van Hauwermeiren: This will happen after the first 30 patients get through part A in the trial and we see if they have a response to Efgatigamot. Remember that in ADHEAR, there is a long screening period to ensure we are getting active CIDP patients. We think this disciplined trial design will pay off in getting the right patients to receive abgartigamoff and to assess the percent of patients whose disease is antibody mediated. CIDP is also the first trial in which we are evaluating the subcute abgartigamot that emerged from our collaboration with Halozyme. This collaboration has turned out to be a key strategic decision and competitive advantage. Herozyme's enhanced delivery technology is well-validated with a documented safety profile across many biologics.

This collaboration has turned out to be a key strategic decision and competitive advantage.

Halozymes enhanced delivery technology, Isabella validated with a document safety profile across many biologics.

By using this technology, we can achieve at least the same RPG deductions as with the 10 make for kick Ivy formulation.

And this in a fast effortless single Subcu injection.

We believe this will be an important offering in each of our indications to get to as many patients as possible.

Tim Van Hauwermeiren: We believe this will be an important offering in each of our indications to get to as many patients as possible. On slide 12, for our pemphigus vulgaris program, we will be launching the Phase 3 trial in H2 2020. We continue to be very excited about this program after the positive results we showed from the adaptive Phase 2 trial. As a quick reminder of the data, we saw that 90% of patients achieved rapid disease control by a median time of 15 and 22 days for monotherapy and combination therapy. Complete clinical remissions were observed in 70% of patients receiving the optimized dosing regimen determined to be efgartigimod dosed at least every two weeks in combination with oral prednisone.

On slide 12.

But our focus for Gaddis program, we will be launching the phase two trial in the second half of Twentytwenty.

Tim Van Hauwermeiren: By using this technology, we can achieve at least the same IgG reductions as with the 10 mg per kg IV formulation, and this in a fast, effortless, single sub-Q injection. We believe this will be an important offering in each of our indications to get to as many patients as possible, as shown on slide 12. For our Pemphigus vulgaris program, we will be launching the phase 3 trial in the second half of 2020. We continue to be very excited about this program after the positive results we showed in the adaptive phase 2 trial. As a quick reminder of the data, we saw that 90% of patients achieved rapid disease control by a median time of 15 and 22 days for monotherapy and combination therapy, respectively. Complete clinical remissions were observed in 70% of patients receiving the optimized dosing regimen, determined to be FGAR-TigaMod dosed at least every two weeks in combination with oral prednisone.

We continue to be very excited about this program. After the positive results. We showed from the adaptive phase two trial.

As a quick reminder of the data we saw that 90% of patients achieved a record disease control by the median time of 15, and 22 days for monotherapy and combination therapy.

Complete clinical remission sort of served in 70% of patients receiving the optimized dosing regimen determined to be I've got picked them up dosed at least every two weeks in combination with oral pragmatism.

70% of patients receiving 25 make the kick up tick them off achieved end of consolidation.

Tim Van Hauwermeiren: 73% of patients receiving 25 mg per kg efgartigimod achieved end of consolidation, including patients who preferred to taper their steroid dose rather than potentially achieving a complete clinical remission. Importantly for PV patients, we also saw a tolerability profile that was favorable and consistent with data from previous efgartigimod studies. Based on these results and on early discussions with physicians, we see how efgartigimod could fit squarely into current treatment practice to address unmet needs. We will be talking more about the Phase 3 program as it gets up and running later this year. Moving on to cusatuzumab on slide 13. Today, we announced a change to the cusatuzumab development strategy, which we believe will best align with a rapidly evolving treatment paradigm in AML. We'd like to first provide a quick reminder of our strategy in partnering this asset.

Including patients who prefer to taper their steroid dose rather than potentially achieving a complete clinical remission.

Importantly for PV patients. We also saw it tolerability profile that was favorable and consistent with data from previous uptick amongst studies.

Based on these results on an early discussions with physicians, we see how I've got pick them up 'cause fits squarely into current treatment practice to address unmet needs.

Tim Van Hauwermeiren: 73% of patients receiving 25 mg per kg of Gartigma achieved end of consolidation, including patients who prefer to taper their steroid dose rather than potentially achieving a complete clinical remission. Importantly, for PV patients, we also saw a tolerability profile that was favorable and consistent with data from previous UpGard Digimod studies. Based on these results and on early discussions with physicians, we see how F-gardigum articles fit squarely into current treatment practice to address unmet needs. We will be talking more about the Phase 3 program as it gets up and running later this year. Moving on to the Q-Solution app on slide 13.

We will be talking more about the 50 program as it gets up and running later this year.

Moving onto cues of fusion I'm on slide 13.

Today, we announced a change to the accused of fusion up development strategy, which we believe will best aligned with rapidly evolving treatment paradigm in ammo.

We'd like to first provide a quick reminder of our strategy in prompting this asset.

She's of Doosan that has a unique mechanism of action targeting cdseventy and leukemic stem cells.

Tim Van Hauwermeiren: Cusatuzumab has a unique mechanism of action, targeting CD70 and leukemic stem cells. We recognize its potential to be broadly used across AML settings and in MDS patients. Janssen is a global oncology player and an ideal partner to accelerate and expand the global development plan we had agreed on together. CULMINATE was the first trial launched under the Janssen collaboration, and we had two primary objectives with it. First was dose selection between 10 and 20 mg/kg cusatuzumab. We achieved this and have selected 20 mg/kg as the go-forward dose. Second was to design a trial that could be registrational in the case of a stellar response rate, clean safety profile, and durable responses. We knew that venetoclax data would be a high bar to beat in accelerating our path to registration.

We recognize this potential to be broadly used across ammo settings and in Mds patients.

Tim Van Hauwermeiren: Today we announce a change to the Q-Zapusumab development strategy which we believe will be best aligned with a rapidly evolving treatment paradigm in AML. We'd like to first provide a quick reminder of our strategy in partnering this asset. Gizartuzumab has a unique mechanism of action targeting CD70 and leukemic stem cells.

Jensen is a global oncology players and an ideal partner to accelerate and expand the global development plan, we had agreed on together.

Culminate was the first try launched the Janssen collaboration and we had two primary objectives for this.

First was dose selection between 10, and 20 milligram per kilogram keys of fusion Matt.

Tim Van Hauwermeiren: We recognize its potential to be broadly used across AML settings and in MDS patients. Jensen is a global oncology player and an ideal partner to accelerate and expand the global development plan we agreed on together. Culminate was the first trial launched of the Jensen collaboration, and we had two primary objectives with it. First, we billed selection between 10 and 20 milligrams per kilogram of quesartuzumab. We achieved this and have selected 20 mg per kilogram as the go-forward dose. Second, we designed a trial that could be registrational in the case of a stellar response, the Clean Safety Profile and Durable Response. We knew that phonetic lag data would be a high bar to beat in accelerating our path to registration.

We achieved this and have selected 20 milligram per kilogram as the go forward dose.

Second was to design a trial that could be registrational indicator of a stellar response rate clean safety profile and durable responses.

We knew that phonetic like data would be high back to beat in accelerating our path to registration.

We plan so that the second trial launched under the collaboration would be a feasible to be trial of Q. So to sum up in combination with Venetoclax and is a fight the dean.

Tim Van Hauwermeiren: We planned so that the second trial launched under the collaboration would be a Phase 1b trial of cusatuzumab in combination with venetoclax and azacitidine. We knew venetoclax had shown early potential in AML and recognized that a combination approach may ultimately be the path forward. Maturing data from CULMINATE suggests that complete response rates are not likely to exceed those from the VIALE-A trial of venetoclax in combination with azacitidine as presented at EHA in June 2020. It is too early to make a judgment on durability of response, and from a tolerability perspective, the profile looks consistent with what we have seen in past trials. We currently think the best path forward for cusatuzumab is to study it in combination with venetoclax to challenge the emerging standard of care.

The new Venetoclax had shown early potential in ml and recognized that a combination approach may ultimately be the path forward.

Maturing data from culminates suggests that complete response rates are not likely to exceed those from the reality eight trial often enter clecs in combination with is a siding as presented that E. In June 2020.

Tim Van Hauwermeiren: We planned so that the second trial launched under the collaboration would be a phase 1b trial of Q-sartuzumab in combination with venetoclax and azacytidine. We knew that venetoclax had shown early potential in AML and recognized that a combination approach may ultimately be the path forward. Maturing data from culmines suggests that complete response rates are not likely to exceed those from the VLA-A trial of venetoclax in combination with azacitidine as presented at IHA in June 2020. It is too early to make a judgment on durability of response, and from a tolerability perspective, the profile looks consistent with what we have seen in past trials.

It is too early to make a judgment on durability of response and from a profitability perspective, the profile looks consistent with what we have seen in past trials.

We currently thing the best path forward for Q Twos map is to study it in combination with phonetic KLAX to challenge the emerging send that off cash.

Tim Van Hauwermeiren: This strategy is supported by positive KOL feedback and by pre-clinical data that were presented at ASH last year, showing synergies between cusatuzumab and venetoclax. We hope to amplify the venetoclax response rates to extend the duration of the responses and to provide a tolerable therapy based on early data we have seen. We expect the registration strategy for cusatuzumab to be determined as we continue to evaluate maturing data across the cusatuzumab program and AML treatment landscape. The CULMINATE trial alone is unlikely to form the basis of a BLA submission. This means that we will not be enrolling more patients into CULMINATE beyond the 103 already enrolled. We will be prioritizing the phase 1b trial of the triple combination of cusa with venetoclax and azacitidine.

This strategy supported by positive by positive cables feedback.

And by preclinical data that were presented at Ash last future showing synergies between cues of fusion map and venetoclax.

We hope to amplify the Venetoclax response rates to extended duration for the sponsors and two provided tolerable therapy based on early data we have seen.

Tim Van Hauwermeiren: We currently think the best path forward for Q-SATUSIMAP is to study it in combination with Venetoclax to challenge the emerging standard of care. This strategy is supported by positive KOL feedback and by preclinical data that were presented at ASH last year showing synergies between Cusartuzumab and Venetoclax. We hope to amplify the venetoclax response rates, to extend the duration of the responses, and to provide a tolerable therapy based on early data we have seen. We expect the registration strategy for Q-SATUSIMAP to be determined as we continue to evaluate maturing data across the Q-SATUSIMAP program and EML treatment landscape. The culminate trial alone is unlikely to form the basis of a BLA submission.

We expect to registration strategy for cues of to sum up to be determined as we continue to evaluate maturing data across accused of choosing a program and AML treatment landscape.

The culminate trial alone is unlikely to form the basis of a BLE submission.

This means that we will not be enrolling more patients into promenade beyond the 100 on the already enrolled.

We will be privatizing the phase Oneb trial of the Triple combination of cues up with Venetoclax and is a cited in.

Tim Van Hauwermeiren: The trial had been on hold due to COVID-19, but is enrolling again at initial sites as well as new sites. You can see on the slide that the MDS trial remains paused and the ongoing trial in Japan, which was not paused due to COVID-19, continues to enroll. We cannot provide detailed data today since they are still maturing, but we have committed to show top-line results from CULMINATE in early 2021, including our rationale for the 20 mg/kg dose selection. We know this is important to you as shareholders, and we're working with Janssen to make this possible. We, of course, would want the fastest path to registration for cusa, but we also want to remain disciplined in our development strategies to ensure we are running trials that make sense within the current treatment environment.

The trial had been on Holt due to covert 19, but isn't rolling again as initial sites as well as new sites.

You can see on the slide that the Mds trial remains Paul.

And the ongoing trial in Japan, which was not cost due to Corbett continues to enroll.

Tim Van Hauwermeiren: This means that we will not be enrolling more patients into culmine beyond the 103 already enrolled. Instead, we will be prioritizing the Phase 1b trial of the triple combination of QSA with venetoclax and azacitidine. The trial had been on hold due to COVID-19 but is enrolling again at initial sites as well as new sites. You can see on the slide that the MDS trial remains open, and the ongoing trial in Japan, which was not stopped due to COVID, continues to enroll. We cannot provide detailed data today since they are still maturing, but we have committed to show top-line results from Cimzia in early 2021, including our rationale for the 20 milligram per kilogram dose selection. We know this is important to you as shareholders, and we are working with Janssen to make this possible.

We cannot provide detailed data today since they are still maturing, but we have committed to show topline results from culminate in early 2021.

Including our rationale for the 20 milligram per kilogram dose selection.

We know this is important to you a shareholders and we had working with janssen to make as possible.

We of course was launched the fastest path registration for cues up but we also want to remain disciplined in our development strategies to ensure we are running trials that make sense within the current treatment environment.

Tim Van Hauwermeiren: We believe that by taking a combination approach, we are moving forward in the best possible way to disrupt the AML treatment paradigm. We would now like to shift quickly to our other development programs, including our wholly owned assets, argenx one seventeen and argenx one eighteen, and those fully in the hands of partners. On slide 14, as I mentioned earlier, we are ready to dose the first healthy volunteers in the Phase 1 trial of argenx one seventeen. This trial was delayed due to COVID, but will now be starting imminently. We believe that by targeting C2, argenx one seventeen could be a pipeline in a product against severe autoimmune diseases in the neuromuscular space and possibly in kidney or heme as well. With the Phase 1 trial, we will assess PK, PD, free C2 levels for dose selection, bioavailability, and ADA.

We believe that by taking a combination approach we are moving forward and the best possible way to disrupt the ammo treatment paradigm.

We would now like to shift quickly to our other development programs, including our wholly owned assets are genex on 17, and our Jennings from 18 and dose fully in the hands of partners.

Tim Van Hauwermeiren: We, of course, would want the fastest possible path to registration for CUSA, but we also want to remain disciplined in our development strategies to ensure we are running trials that make sense within the current treatment environment. We believe that by taking a combination approach, we are moving forward in the best possible way to disrupt the AML treatment paradigm. We would now like to shift quickly to our other development programs, including our wholly owned assets, ArgenX Fond 17 and ArgenX Fond 18, and those fully in the hands of partners, on slide 14. As I mentioned earlier, we are ready to dose the first healthy volunteers in the phase 1 trial of ArgenX 117. This trial was delayed due to COVID but will now be starting imminently.

On slide 14.

As I mentioned earlier, we are ready to dosed the first healthy volunteers in the phase one trial of our Genex on 17.

This trial was delayed due to corbett, but will not be starting imminently.

We believe that by targeting C are getting some 17 could be a pipeline in the product against Soviet autoimmune diseases in the neuromuscular space and possibly in kidney or here as well.

With the phase one trial, we will assess PK PD.

We see two levels for dose selection bio availability and 80.

We will also look at safety and Tolerability.

Tim Van Hauwermeiren: We will also look at safety and tolerability. Our plan is that once we identified a dose from the phase 1 trial, we can launch parallel trials in autoimmune indications. We have already identified an initial indication, multifocal motor neuropathy, which is a rare, typically progressive neuromuscular disease that can greatly impact the quality of patients' life. We also know that complement plays a key role in acute respiratory distress syndrome associated with COVID-19. This has been shown to be a deadly complication of the infection. We are working with our immunology innovation program collaborator, Bart Lambrecht, to make ARGX-117 available to COVID patients at the Ghent University Hospital. This is currently the only site for the trial, and thankfully, there are no longer many available COVID patients in this region. We will continue to move forward with ARGX-117 development plan in healthy volunteers.

Our plan is that once we identified a dose from the phase one trial, we can launch parallel trials in autoimmune indications.

Tim Van Hauwermeiren: We believe that by targeting C2, ArgenX 117 could be a pipeline product against severe autoimmune diseases in the neuromuscular space and possibly in kidney or heme as well. With the phase one trial, we will assess PK, and PD. 3C2 levels for dose selection, bioavailability, and AD. We will also look at safety and tolerability. Our plan is that once we identify a dose from the phase 1 trial, we can launch parallel trials in autoimmune indications. We have already identified an initial indication, multifocal motor neuropathy, which is a rare, typically progressive, neuromuscular disease that can greatly impact the quality of patients.

We have already identified an initial indication multi focal multiple neuropathy, which is a rare typically progressive neuromuscular disease that can greatly impact the quality of patients life.

Also note that complement plays a key role in acute respiratory distress syndrome associated with corporate 19.

This has shown to be a deadly complication of infection.

We are working with our immunology innovation program collaborated bulk lump direct to make our genex on 17 available to open patients at the tenants academic hospital.

This is currently the only sites for the trial and thankfully that are no longer many available cold patients in this region.

Tim Van Hauwermeiren: Also note that complement plays a key role in the acute respiratory distress syndrome associated with COVID-19. This has shown to be a deadly complication of the infection. We are working with our Immunology Innovation Program collaborator Bart Lombrecht to make ArgenX 117 available to COVID patients at the Ghent Academic Hospital. This is currently the only site for the trial, and fortunately, there are no longer many available COVID patients in this region. We will continue to move forward with ArgenX RON17's development plan in healthy volunteers, and should there be a second wave of COVID in Belgium, we will make the drug available, possibly with more in-human data at that point. We are also making progress in selecting a lead for ArgenX FON 18 and are preparing to announce ArgenX FON 19 this year, slide 15. As you know, our Immunology Innovation Program has also been a productive engine for assets with which we have partnered.

We will continue to move forward with our Gentex on 17 development plan in healthy volunteers and should there be a second wave of covered in Belgium, we will make the drug available, possibly but more in human data at that point.

Tim Van Hauwermeiren: Should there be a second wave of COVID in Belgium, we will make the drug available, possibly with more in-human data at that point. We are also making progress in selecting a lead for ARGX-118 and are preparing to announce ARGX-119 this year. On slide 15, as you know, our immunology innovation program has also been a productive engine for assets which we have partnered. ARGX-112, which is now LP0145 in the hands of LEO Pharma. They had paused a Phase 1 trial in atopic dermatitis due to COVID, but are preparing to reopen sites later this summer. ARGX-114 is now AGMB-101 in the hands of AgomAb, and ARGX-115 is now ABBV-151 in the hands of AbbVie.

We're also making progress in selecting elite Progenics from 18 and are preparing to announce our Jennings from 19 this year.

On slide 15.

As you know our immunology innovation program has also been a productive engine for assets, which we have pilots.

Our Jennings from 12, which is now LP 0145 in the hands of Leo pharma.

The head post a phase one trial in it up in dermatitis due to Corbett, but are preparing to reopen sites later this summer.

Our Jennings from 14 is now ATM be one along in the hands of I come up.

And our Jennings from 15 is now ABDC won five warm in the hands of Abbvie.

Tim Van Hauwermeiren: We do not have any update on these molecules today, but you will recall that AbbVie did not pass their trial in solid tumors due to COVID, so this study remains ongoing. We also recently learned from Staten that they initiated dosing in the first in-human trial of STT-5058, targeting APOC3 for the potential treatment of dyslipidemia. This was formerly ARGX-116. Our commitment as part of our argenx 2021 vision is that we will continue to prioritize our immunology innovation program even as we become a commercial organization. In being a fully integrated immunology company, we want to be as much a commercial organization as an R&D engine. With that overview, I will now turn the call over to Keith for a discussion of our commercial readiness.

We do not have any update on these molecules today, but you will recall that abbvie did not passed that trial in solid tumors due to Corbett. So this study remains ongoing.

Tim Van Hauwermeiren: ArgenX 112, which is now LP0145 in the hands of Leo Pharma. They had paused a phase 1 trial in atopic dermatitis due to COVID, but are preparing to reopen sites later this summer. ArgenX 1.14 is now AGMB 1.0.1 in the hands of Agomap, and ArgenX 1.15 is now ABBV 1.5.1 in the hands of AbbVie. We do not have any update on these molecules today, but you will recall that AbbVie did not pass that trial in solid tumors due to COVID. So this study remains ongoing. We also recently learned from Staten that they initiated dosing in the first in-human trial of STT 5058 targeting ApoC3 for the potential treatment of dyslipidemia. This was formerly ArgenX 116. Our commitment as part of our ArgenX21 vision is that we will continue to prioritize our immunology innovation program even as we become a commercial organization. In being a fully integrated immunology company, we want to be as much a commercial organization as an R&D engine. With that overview, I will now turn the call over to Keith for a discussion of our commercial readiness.

We also recently learned from staton that they initiated dosing in the first in human trial of STT 50, 58 targeting April C for the potential treatment of Dyslipidemia dispose formally our genex on 16.

Our commitment as part of our Allergenic 20 wrong vision.

Is that we will continue to prioritize our immunology innovation program, even as we become a commercial organization.

In being a fully integrated immunology company, we want to be as much in commercial organization as an R&D engine.

With that overview I will now turn the call over two key for a discussion of our commercial readiness.

Thank you, Tim and good morning, everyone.

Keith Woods: Thank you, Tim, and good morning, everyone. Please see slide 16. Today, I want to give you an update on some of the ways in which we are preparing for a successful launch of efgartigimod in the US in 2021 and in Japan following the US launch. We've been providing you updates on our commercial preparation for over a year now, but following the positive Phase 3 data readout, we have felt a dynamic shift in the work we are doing to get efgartigimod to patients as quickly as possible. I can tell you today that all commercial preparation activities are on track across each of the key work streams. As a first step, we are right on track with our BLA filing to the FDA and with our JNDA filing to the PMDA in Japan.

Please see slide 16.

Today I want to give you an update on some of the ways in which we are preparing for a successful launch about garnered some odd in the U.S. in 2021 and in Japan. Following the U.S. launch we've been providing you updates on our commercial preparation for over a year now.

But following the positive phase three data read out we have felt that dynamic shift and the work we're doing to get garlic them on to patients as quickly as possible.

Keith Woods: Thank you, Tim. And good morning, everyone. Please see slide 16. Today, I want to give you an update on some of the ways in which we are preparing for a successful launch of Afghar-e-Gamad in the US in 2021 and in Japan following the US launch. We've been providing you updates on our commercial preparation for over a year now, but following the positive phase three data readout, we have felt a dynamic shift in the work we are doing to get Epgardigumab to patients as quickly as possible. I can tell you today that all commercial preparation activities are on track across each of the key work streams. As a first step, we are right on track with our BLA filing to the FDA and with our JMAA filing to the PMDA in Japan. The BLA will be filed by the end of 2020, and the JMAA in the first half of 2021.

I can tell you today that all commercial preparation activities are on track across each of the key work streams.

The first step we're right on track with our de La filing to the FDA and with our J M. A filing to the PMDA in Japan.

Keith Woods: The BLA will be filed by the end of 2020 and the J-NDA in H1 2021. This will be a rolling submission, allowing for us to include longer-term safety data from the ADAPT Plus trial as we have it. We additionally are planning to meet with the FDA in Q4 of this year to talk about our subcutaneous formulation of efgartigimod and how we can initiate a bridging strategy to get it into MG patients as soon as possible. This is a top corporate priority. We are right where we need to be in terms of supply chain preparation. We have a long-established alliance with Lonza, and manufacturing for efgartigimod is currently out of two different locations, one in the UK, and one in Singapore. We will be ready with our commercial inventory in time for both our US and our Japan launches.

The BLE will be filed by the end of 2020 and the J M. A in the first half of 2021.

This will be a rolling submission, allowing for us to include longer term safety data from the adapt flush trial as we have it.

We addition, they're planning to meet with the FDA and the fourth quarter of this year to talk about our subcutaneous formulation of the garlic.

And how we can initiate a bridging strategy to get into EMG patients as soon as possible.

This is a top corporate priority.

We're right, where we need to be in terms of supply chain preparation.

We have a long established alliance with Lonza and manufacturing for F. Garlic Ahmad is currently out of two different locations one in the UK and one in Singapore.

Keith Woods: This will be a rolling submission allowing for us to include longer-term safety data from the ADAPT Plus trial as we have it. We are additionally planning to meet with the FDA in the fourth quarter of this year to talk about our subcutaneous formulation of FGARDIGMOD and how we can initiate a bridging strategy to get it into MG patients as soon as possible. This is a top corporate priority. We are right where we need to be in terms of supply chain preparation. We have a long-established alliance with Lanza, and manufacturing for AfgardigaMod is currently out of two different locations, one in the UK and one in Singapore.

We will be ready with our commercial inventory and time for both our us and our Japan launches.

Keith Woods: We also have the scale-up potential to expand our manufacturing capacity to a third location in the US as we reach even more patients and more geographies. We have entered into collaboration with Cardinal Health as our US third-party logistics partner and in the process of building a strategic and patient-centric network of specialty pharmacy and specialty distribution partners to ensure broad access. Additionally, we're in the early phases of engaging with US payers and will continue these conversations as we progress to launch. Our interactions with physicians continue to be a top priority, and we have been able to engage with them virtually over the last several months.

We also have the scale of potential to expand our manufacturing capacity to a third location in the U.S.

As we reach even more patients and more geographies.

We have entered into collaboration with Cardinal health as our use third party logistics partner and in the process of building strategic and patient centric network of specialty pharmacy, and specialty distribution partners to ensure broad access.

Keith Woods: We will be ready with our commercial inventory in time for both our U.S. and our Japan launches. We also have the scale-up potential to expand our manufacturing capacity to a third location in the U.S. as we reach even more patients and more geography. We have entered into collaboration with Cardinal Health as our U.S. third-party logistics partner and are in the process of building a strategic and patient-centric network of specialty pharmacy and specialty distribution partners to ensure broad access. Additionally, we're in the early phases of engaging with U.S. payers and will continue these conversations as we progress to launch. Our interactions with physicians continue to be a top priority, and we have been able to engage with them virtually over the last several months.

Additionally, we are in the early phases of engaging with us payers and we'll continue these conversations as we progress to launch.

Our interactions with physicians continue to be a top priority.

And we have been able to engage with them virtually over the last several months.

Keith Woods: In sharing our ADAPT data with the physicians, we've heard positive feedback on the potential for an individualized dosing approach, since patients with myasthenia gravis have different courses of disease and would benefit from a treatment option that is purpose-fit to this variability. On slide 17, we know that in the US there are 16,000 neurologists who actively treat 65,000 adult MG patients. Of those 65,000 patients, 20,000 with generalized MG, 20,000 of them will likely need treatment beyond steroids and other current options. This is what we see as the target addressable market for efgartigimod in the US. In Japan, there are about 20,000 total MG patients that suffer from MG and are treated by 200 to 300 neurologists.

And sharing our adapt data with the physicians, we've heard positive feedback on the potential for an individualized dosing approach since patients with my Affinia gravis have different courses of disease and would benefit from a treatment option that is purpose fit to this variability.

On slide 17.

We know that in the U.S. There are 16000, neurologists, who actively treat 65000 adult EMG patients.

65000 patients 20000 with generalized EMG.

Keith Woods: In sharing our ADAPT data with physicians, we've heard positive feedback on the potential for individualized dosing. Patients with myasthenia gravis have different courses of disease and would benefit from a treatment option that is purpose-fit to this variability, on slide 17. We know that in the U.S., there are 16,000 neurologists who actively treat 65,000 adult M.G. patients, of those 65,000 patients, 20,000 with generalized MG. Jim.

Mm Hmm.

20000.

We'll likely need treatment beyond steroids and other current options.

This is what we see it the target addressable market for F guard to come out in the U.S.

In Japan, they're about 20000 total mg patients that suffer from Mg and are treated by 200 to 300 neurologists.

For physicians, we can't underestimate the importance of education when it comes to launching a first in class drug with a new therapeutic modality.

Keith Woods: For physicians, we can't underestimate the importance of education when it comes to launching a first-in-class drug with a new therapeutic modality. We will be educating on the crucial role of the antibody in MG, but also on the central role of FcRn in modulating IgG homeostasis. Our field force will be instrumental in reaching our target physicians. We have already hired an expansive team of medical research liaisons that specialize in the neuromuscular space. This team was crucial during our phase 3 trial to be a resource for investigators. As we approach launch, they will continue to be a resource for an even broader community of neurologists. We additionally have a growing team of thought leader liaisons who will build relationships with the top MG physicians and support our marketing efforts.

We will be educating on the crucial role of the antibody and EMG, but also on the central role of Fcr and and modulating IBG homeostasis.

Keith Woods: 20,000 of them will likely need treatment beyond steroids and other current options. This is what we see as the target addressable market for Efgardagamad in the U.S. In Japan, there are about 20,000 total M.G. patients.

Our field force will be instrumental in reaching our target physicians, we have already hired an expansive team of medical research Liaised liaison that specialize in the neuromuscular space.

Keith Woods: patients that suffer from M.G. and are treated by 200 to 300 neurologists. For physicians, we can't underestimate the importance of education when it comes to launching a first-in-class drug with a new therapeutic modality. We will be educating physicians on the crucial role of the antibody in MG but also on the central role of FCRN in modulating IgG homeostasis.

This team was crucial during our phase three trial to be a resource for investigators.

As we approach launch they will continue to be a resource for an even broader community of neurologists.

Additionally have a growing team of thought leader liaisons, who will build relationships with the top EMG positions and support our marketing efforts.

Keith Woods: Our field force will be instrumental in reaching our target physicians. We have already hired an expansive team of medical research liaisons that specialize in the neuromuscular space. This team was crucial during our Phase 3 trial as a resource for investigators. As we approach launch, they will continue to be a resource for an even broader community of neurologists. We additionally have a growing team of thought leader liaisons who will build relationships with the top M.G. physicians and support our marketing efforts. We'll start to hire our sales force during the third quarter of this year and expect to have 70 to 80 representatives for our commercial launch, on slide 18.

Keith Woods: We'll start to hire our sales force during Q3 of this year and expect to have 70 to 80 representatives for our commercial launch. On slide 18, all of our preparatory work to successfully launch efgartigimod is ultimately about reaching patients who continue to suffer the effects of MG. We hear from patients about the severe and sometimes life-threatening symptoms of MG. As argenx continues to grow its presence within the MG community, we want to build awareness of the key unmet need that still exists. To accomplish this, we have launched a digital disease awareness platform in June called MG United, offering personalized information and resources for those affected by MG. This is the first of many initiatives that will be available to the MG community.

We will start to hire our salesforce during the third quarter of this year and expect to have 70 to 80 representatives for our commercial launch.

On slide 18.

All of our preparatory work to successfully launched zipcar to come up is ultimately about reaching patients who continue to suffer the effects of EMG.

We hear from patients about this severe and sometimes life threatening symptoms of Mg.

As our Genex continues to grow its presence within the EMG community. We went to build awareness of the key unmet need it's still exists.

To accomplish this we have launched a digital disease awareness platform in June called Mg, United offering personalized information and resources. So those affected by Mg.

Keith Woods: All of our preparatory work, and the successfully launched f-cardiogamab is ultimately about reaching patients who continue to suffer the effects of MG. We hear from patients about the severe and sometimes life-threatening symptoms of MG. As ArgenX continues to grow its presence within the MG community, we want to build awareness of the key unmet need that still exists. To accomplish this, we launched a digital disease awareness platform in June called MG United, offering personalized information and resources for those affected by MG. This is the first of many initiatives that will be available to the MG community. We have also been working closely with the Myasthenia Gravis Foundation of America to be available to patients during the COVID-19 pandemic. People living with MG already experience feelings of isolation, and the social distancing requirements only amplifies this.

This is the first of many initiatives that will be available to the EMG community.

We have also been working closely with demised stimulus Gravis Foundation of America could be available to patients during the cobot 19 pandemic.

Keith Woods: We have also been working closely with the Myasthenia Gravis Foundation of America to be available to patients during the COVID-19 pandemic. People living with MG already experience feelings of isolation, and the social distancing requirements only amplifies this. Given the number of those COVID cases we continue to see, we are planning for a fully virtual launch if necessary. We are grateful that we have had time to acclimate and learn from virtual interactions with each of our key stakeholders and think that this will help us prepare for a successful launch in any setting. With that, I'd like to hand the call over to Eric for a review of our financial results.

People living with EMG already experienced feelings of isolation and the social distance and requirements only amplifies. This.

Given the number of coast Cobot cases, we continue to see.

We are planning for a fully virtual launch if necessary. We are grateful that we have had time to acclimate and learned from virtual interactions with each of our key stakeholders and think that this will help us prepare for sex successful launch in any setting.

With that I'd like to hand, the call over to Eric for review of our financial results.

Thank you Keith.

Eric Castaldi: Thank you, Keith. Slide 19 covers our H1 2020 operating results, which are detailed in today's press release and regulatory filings. Total operating income for the six months ended 30 June 2020 was EUR 31.1 million, a decrease of EUR 20.2 million from the same period in 2019 due to milestone payments we received last year under the AbbVie collaboration agreement and partially offset by the revenue recognition of the transaction price related to the Janssen collaboration and an increase in other income driven by higher payroll tax rebates. R&D expenses for the six months ended 30 June 2020 were EUR 171.7 million compared to EUR 78.3 million for the same period in 2019.

Slide 19 co deals over 100 here Twentytwenty operating results, which are detailed in today's press could easily collectively finals.

Keith Woods: Given the number of COVID cases we continue to see, we are planning for a fully virtual launch if necessary. We are grateful that we have had time to acclimate and learn from virtual interactions with each of our key stakeholders and think that this will help us prepare for a successful launch in any setting. With that, I'd like to hand the call over to Eric for a review of our financial results.

Total operating income for the six months ended June Phil just Twentytwenty was 61.1 million you a decrease of 20.2 million euros from December period in 2019.

Due to a nice to payments, we received last year under the of the collaboration agreements.

Erica Salde: Thank you, Keith. Slide 19 covers our half-year 2020 operating results, which are detailed in today's press release and regulatory filing. Total operating income for the 6 months ended June 30, 2020 was €31.1 million, a decrease of €20.2 million from the same period in 2019. Due to the milestone payments we received last year under the AVI collaboration agreement, I'm partially upset by the revenue recognition of the transaction price related to the Janssen collaboration and an increase in other income driven by higher payroll tax rebates. R&D expenses for the six months ended June 30, 2020 were €171.7 million, compared to €78.3 million for the same period in 2019. Selling general and administrative expenses were 61.6 million euros for the six months ended June 30, 2020, compared to 27.5 million euros for the same period in 2009.

Actually upset by the look when you look admission of the collection price related to the unsaid collaborations.

And an increase in those other income driven by higher payroll tax rebates.

R&D expenses for the six months ended June searches Twentytwenty were 171.7 million euros compared to 78.3 million euros for the same period in 2019.

Selling general and administrative expenses were 61.6 million euros for the six months ended June so just twentytwenty compared to 27.5%, sorry, 27.5 million euros for the same period in 2018.

Eric Castaldi: Selling, general, and administrative expenses were EUR 61.6 million for the six months ended 30 June 2020, compared to EUR 27.5 million for the same period in 2019. These increases in R&D and SG&A expenditures over the prior year have been driven by the progress made within our late stage pipeline, including higher consulting and personnel expenses, higher clinical trial costs, and manufacturing expenses, and also the recruitment of additional employees to support ongoing activities. We expect operating expenses to continue to increase this year as we further advance our pipeline and prepare for future commercialization.

These increases in R&D and SGN expenditures over the prior year I've been driven by the progress made within our late stage pipeline, including higher consulting and personal expenses.

Your clinical trial cost and manufacturing expenses and also the recruitment of additional employees to support ongoing activities.

We expect operating expenses to continue to increase this year as we further advancing our pipeline and prepare for future commercialization.

Erica Salde: These increases in R&D and SG&A expenditures over the prior year have been driven by the progress made within our late-stage pipeline, including higher consulting and personal expenses, higher clinical trial costs, and manufacturing expenses, and also the recruitment of additional employees to support ongoing activities. We expect operating expenses to continue to increase this year as we further advance our pipeline and prepare for future commercials. For the 6 months ended June 30, 2020, financial expenses, which primarily relate to interest received and changes in fair value of current financial assets, amounted to 2.2 million euros, compared to a financial income of 7.2 million euros for the same period in 2019, exchange gains totaled 0.2 million euros for the six-month period and on June 30th, 2020, compared to 2.5 million for the same period in 2009.

For the six months ended June still just Twentytwenty financial expenses, which primarily relates to interest received and changes in fair value of current sanish and assets amounted to 2.2 million euros compared to a financial income of 7.2 million euros for the same period in 2000.

Eric Castaldi: For the six months ended 30 June 2020, financial expenses, which primarily relate to interest received and changes in fair value of current financial assets, amounted to EUR 2.2 million compared to a financial income of EUR 7.2 million for the same period in 2019. Exchange gains totaled EUR 0.2 million for the six months period ended 30 June 2020, compared to EUR 2.5 million for the same period in 2019. The total net loss for the six months ended 30 June 2020 was EUR 205.6 million compared to a net loss of EUR 45.1 million and an operating loss of EUR 54.5 million for the same period in 2019.

90.

Exchange gains.

Two told 0.2 million euros for the six month period.

Periods ended June still CIS twentytwenty compared to 2.5, he unfold the same give you in 2019.

The total net loss for the six months ended June. So just Twentytwenty was 205.6 million euros compared to a net loss of 45.1 million euros and local the team loss of 54.5 million euros for the same period in 2019.

We ended the first ALS or Twentytwenty leaves 1.9 billion euros in cash cash equivalents and current assets compared to 1.3 billion euros on December 31st 2019.

Eric Castaldi: We ended H1 2020 with EUR 1.9 billion in cash equivalents, and current assets, compared to EUR 1.3 billion on 31 December 2019. The increase was primarily due to the closing of a global equity offering, including a US offering and a European private placement, resulting in the receipt of EUR 730.7 million net proceeds in June 2020. I will now turn the call back to Tim.

Erica Salde: The total net loss for the six months ended June 30th, 2020, was 205.6 million euros, compared to a net loss of 45.1 million euros and an operating loss of 54.5 million euros for the same period in 2019. We ended the first half of 2020 with 1.9 billion euros in cash, cash equivalents, and current assets, compared to 1.3 billion euros on December 31st, 2019. The increase was primarily due to the closing of a global offering, including a US offering and a European private placement, resulting in the receipt of 733.7 million euros in net proceeds in June 2020.

The increase was primarily due to the closing of the global offering, including the us offering and a European private placements. He's looking in the receipt of 750.7 million euros net proceeds in June 2020.

I'll now turn the call back to team.

Keith Woods: Thank you, Eric. Before we open up the call for questions, I would like to turn to slide 20. We are very excited by what is ahead at argenx. We are focused across the company on the filing of our first BLA and the launch of our first drug in the United States. As we shift to be a commercial organization, we are committed to further building out our differentiated pipeline of antibody therapies.

Tim Van Hauwermeiren: Thank you, Eric. Before we open up the call for questions, I would like to turn to slide 20. We are very excited by what is ahead at argenx. We are focused across the company on the filing of our first BLA and the launch of our first drug in the United States. As we shift to be a commercial organization, we are committed to further building out our differentiated pipeline of antibody therapies. Both by advancing our ongoing clinical trials as quickly as possible and by identifying new value creation opportunities through our immunology innovation program.

Thank you Eric.

Before we open up the call for questions.

I would like to turn to slide 20.

We're very excited by what is ahead of our Genex, we're focused across the company on the filing of our first Bailey and the launch of our first drug in the United States.

As we shift to be a commercial organization. We are committed to further building out our differentiated pipeline of antibodies therapies, both by advancing our ongoing clinical trials as quickly as possible and by identifying new value creation opportunities through our immunology innovate.

Eric: I will now turn the call back to Tim.

Tim Van Hauwermeiren: Thank you, Eric. Before we open up the call for questions, I would like to turn to slide 20.

Tim Van Hauwermeiren: Both by advancing our ongoing clinical trials as quickly as possible and by identifying new value creation opportunities through our immunology innovation program. With a cash position of EUR 1.9 billion and a strong and rapidly expanding team, we know we are in pole position to execute our business plan to generate value for our shareholders in the long term. We continue to be inspired by the resilience and hope of our patients and believe we are closer than ever to reaching them through our commitment to immunology innovation. With that, I will now ask the operator to open the call for your questions.

Tim Van Hauwermeiren: We are very excited by what is ahead at ArgenX. We are focused across the company on the filing of our first BLA and the launch of our first drug in the United States. As we shift to be a commercial organization, we are committed to further building out our differentiated pipeline of antibody therapies, both by advancing our ongoing clinical trials as quickly as possible and by identifying new value creation opportunities through our Immunology Innovation Program. With a cash position of 1.9 billion euros and a strong and rapidly expanding team, we know we are in a prime position to execute our business plan to generate value for our shareholders in the long term. We continue to be inspired by the resilience and hope of our patients and believe we are closer than ever to reaching them through our commitment to immunology innovation. With that, I will now ask the operator to open the call for your questions.

Asian program.

With a cash position of 1.9 billion euros and is strong and rapidly expanding team. We know we are in position to execute our business plan to generate value for our shareholders in the long term.

Tim Van Hauwermeiren: With a cash position of EUR 1.9 billion and a strong and rapidly expanding team, we know we are in pole position to execute our business plan to generate value for our shareholders in the long term. We continue to be inspired by the resilience and hope of our patients and believe we are closer than ever to reaching them through our commitment to immunology innovation. With that, I will now ask the operator to open the call for your questions.

We continue to be inspired by the resilience and hope of our patients and believe we are closer than ever to reaching them through our commitment to immunology innovation.

With that I will now as the operator to open the call for your questions.

Thank you for deeper disciplines. If you have any questions can you press star one on your telephone keypad and rates remain to be announced the passenger IEC lots that depressed the Ashton.

Operator: Thank you. For the participants, if you have any questions, kindly press star one on your telephone keypad and wait for your name to be announced. To cancel your request, kindly press the hash key. Once again, star one if you have any questions. Question. It's from the line of Derek Archila from Stifel. You may ask your question.

Against bottom line, if you have any question.

Question, it's from the line of Bevec Archie loan from by phone ask your question.

Hi, Bill on for Derek Thanks for the update and taking the questions.

Bill: Hi, Bill on for Derek. Thanks for the update and taking the questions. So just on cusatuzumab, can you just remind us whether or not the update has any impact on the terms of the deal with J&J? Then sort of on the Phase 1b, can you talk a little bit about how, you know, in the evolving landscape of AML, you know, you sort of think the bar will be in the, you know, in the combination study with Aza and venetoclax? Thanks.

Bill Maughan: Hi, Bill on for Derek. Thanks for the update and taking the questions. So just on cusatuzumab, can you just remind us whether or not the update has any impact on the terms of the deal with J&J? Then sort of on the Phase 1b, can you talk a little bit about how, you know, in the evolving landscape of AML, you know, you sort of think the bar will be in the, you know, in the combination study with Aza and venetoclax? Thanks.

Operator: Thank you. For the participants, if you have any questions, kindly press star 1 on your telephone keypad and wait for your name to be announced. To cancel your request, kindly press the hash against R1. If he has a Next question, it's from the line of Derek Archila from Spifle. He asks... Hi, Bill, on behalf of Derek.

So just on the tourism as.

Can you just remind us whether or not the update has any impact on the terms of the deal with Jane Jay.

And then sort of on the phase one be can you talk a little bit about how you know India evolving landscape of and now you sort of think the bar will be in the in the combination study with Ace Internet <unk>. Thanks.

Derek Christian Archila: Thanks for the update and taking the questions. So just one quiz or two is a matter of... Can you just remind us whether or not the update has any impact on the terms of the deal with J&J? And then sort of on phase 1b, can you talk a little bit about how, you know, in the evolving landscape of AML, you know, you sort of think the bar will be in the combination study with AZA and venetoclax? Thanks.

No. Thank you for the question I. Thank you for being with US today, So the and strategy change, which we announced today is not affecting by any means the terms of the deal.

Tim Van Hauwermeiren: No, thank you for the question, and thank you for being with us today. The strategy change which we announced today is not affecting by any means the terms of the deal. Actually, the way you have to look at the global development plan, which is an intrinsic part of the contract, is that there's nothing else than a decision tree which we can navigate based on data. With this new data point from VIALE-A coming in, we know that in our strategy we have to give a priority to the Phase 1b study, where we combine with what is now likely gonna be the future standard of care. Where is the bar?

Actually the way you have to look at the global development plan, which is an intrinsic part of the contract is that this nothing has done a decision tree, which we can navigate based on data. So with this new data points from reality a coming in we know that in our strategy, we have to give priority to the phase from this study.

Tim Van Hauwermeiren: Now, thank you for the question and thank you for being with us today. So the strategy change which we announced today is not affecting, by any means, the terms of the deal. Actually, the way you have to look at the global development plan, which is an intrinsic part of the contract, is that there's nothing else but a decision tree which we can navigate based on data. So with this new data point from VIALI-A coming in, we know that in our strategy, we have to give priority to the Phase 1B study, where we combine it with what is now likely going to be the future standard of care. So where is the bar?

Where we combined with what is now likely going to be the future standard of cash.

So where does the bar.

Tim Van Hauwermeiren: Well, we know that VIALE-A had a 37% CR rate and a 15-month overall survival, which is a benefit of about five months compared to Vidaza alone. While venetoclax Vidaza has shown strong data to induce CRs, the question remains, you know, how you can keep people in a stable remission. The bar to be beaten will not just be in terms of CR rates, but also in the durability of these CRs and the safety of the combination.

Well, we know that the Ali a had a 37% CR rate and a 15 months overall survival, which is a benefit of about 55 months compared to five days a alone.

And while Venetoclax CLI data has shown strong data to induce see us. The question remains you know how you can keep people in a stable remission. So the back to beat and will not just be in terms of CR rates, but also in the durability of DCR and the safety of the combination.

Tim Van Hauwermeiren: Well, we know that VLA-A had a 37% CR rate and a 15 months overall survival, which is a benefit of about five months compared to Vydesa alone, and while venetoclax videsa has shown strong data to induce CRs the question remains you know how you can keep people in a stable remission, So the bar to be beaten will not just be in terms of CR rate, but also in the durability of these CRs and the safety of the combination.

That makes sense. Thanks.

Bill: That makes sense. Thanks.

Bill Maughan: That makes sense. Thanks.

Tim Van Hauwermeiren: Thank you.

Thank you.

Next question that's front the lineup Yaron werber from called in the massive question.

Operator: Next question is from the line of Yaron Werber from Cowen. You may ask your question.

Thanks for taking the question. So maybe a couple of questions on the Subcu bridging study and the strategy I mean.

Yaron Werber: Thanks for taking the question. Maybe a couple of questions on the sub-Q bridging study and the strategy. I mean, as you noted, you're gonna be meeting with FDA in Q4 and both to advance it sort of in ITP, but also importantly obviously in MG. The MG landscape is, you know, as expected, it's gonna be a big market. There's a few competitors coming in, talking about sub-Q dosing. In those cases, some potentially are gonna be looking at sort of fixed interval sub-Q doses chronically. Thoughts about that and how do you bridge from your intermittent dosing to sub-Q, and is there a chance sub-Q is gonna be fixed or is that gonna be intermittent still? Thank you.

Noted you're gonna be meeting with FDA in Q4 and both too.

Advance it sort of an IP, but also importantly, obviously and then GE and DMG landscape is expected to be big market. Those few competitors coming in are talking about subcu dosing in those cases, some potential they're going to be looking at sort of fixed interval subcu dosage chronically, so thoughts about that and how.

Derek Christian Archila: That makes sense. Thanks. Thank you.

Yaron Benjamin Werber: Next question, it's from the line of Yaron Werber from Colburn. You may ask. Thanks for taking the question. So maybe a couple of questions on the sub-Q bridging study and the strategy. I mean, as you noted, you're going to be meeting with FDA in Q4, both to advance it sort of in ITP, but also importantly, obviously, in MG. And the MG landscape is, you know, as expected, it's going to be a big market. There are a few competitors coming in talking about sub-Q dosing. In those cases, some are potentially going to be looking at sort of fixed interval sub-Q doses chronically. So thoughts about that, and how do you bridge from your intermittent dosing to sub-Q? And is there a chance sub-Q is going to be fixed, or is that going to be intermittent? Sure. Thank you.

Do you bridge from your intermittent dosing to Subcu and is there a chance up she was going to be fixture is not going to be inter making sure. Thank you.

Thank you gentlemen, thank you for being with US today, Keith would you like to take this question. Please.

Tim Van Hauwermeiren: Thank you, Yaron. Thank you for being with us today. Keith, would you like to take this question, please?

Sure. Thank you.

Keith Woods: Sure. Thank you. As we noted, we will go meet with the FDA and discuss the bridging strategy for MG. We also are bringing sub-Q forward in ITP, and additionally, it's the preferred route of administration in CIDP. In regard to the exact treatment regimen that we will use in MG, we'll comment more on this after we have had our meeting with the FDA, but as you know from the ADAPT study, we do have individualized dosing, and it varies among our various patients. I do see the possibility with our sub-Q of not only being able to use it on an individualized treatment basis, but some might be on a more fixed dose.

As we noted that we will go meet with the FDA and discuss the bridging strategy for AMG. We also are bringing Subcu board.

In ITD.

Additionally, it's the preferred and see I'd peak route of administration.

In regard to the exact.

Treatment regimen that we will use and EMG will comment more on this after we've had our meeting with the FDA, but as you know from the adapt study, we do have individualize dosing and it varies amongst our our various patients. So I do see the possibility with our subcu of not only being able to.

Yaron Benjamin Werber: Thank you, Yaron. Thank you for being with us today. Akit, would you like to take this question, please?

Keith Woods: Sure, thank you. As we noted, we will go meet with the FDA and discuss the bridging strategy for MG. We are also bringing sub-2 forward in ITP. And additionally, it's the preferred route of administration in CIDP. In regard to the exact treatment regimen that we will use in MG, we'll comment more on this after we have had our meeting with the FDA. But as you know, from the ADAPT study, we do have individualized dosing, and it varies amongst our various patients. So I do see the possibility with our sub-2 of not only being able to use it on an individualized treatment basis, but some might be on a more fixed dose.

You use it on an individualized treatment basis, but some might be on a more fixed a fixed dose.

And your defense, yet with on the energy strategy.

Yaron Werber: Do you have a sense yet with on the MG strategy what the FDA might require? You know, obviously they're gonna looking at PK, but they're gonna wanna look at some PD efficacy. Is it possible to do a bridging study that's got a primary endpoint at 8 weeks and maybe run a 24-week study and that's sufficient for approval? Thanks so much.

What the FDA might require is obviously, they're going to looking at PK, but they're going to want to look at some pediatric I'd say is it possible could do a bridging study that's got a primary endpoint. It eight weeks and maybe run a 24 week study and thats sufficient for approval. Thanks, so much.

Yeah, I still think it's too early for us to comment on exactly what they did what they are going to require but I think it's fair to say that we will need some exposure in EMG patients, but let's wait and see till we hear back from the FDA.

Keith Woods: Yeah, I still think it's too early for us to comment on exactly what they are going to require, but I think it's fair to say that we will need some exposure in MG patients. Let's wait and see till we hear back from the FDA.

Yaron Benjamin Werber: And do you have a sense yet about what the FDA might require for the MG strategy? Obviously, they're going to look at PK, but they're going to want to look at some PD efficacy. Is it possible to do a bridging study that's got a primary endpoint at eight weeks and maybe run a 24 week study and that's sufficient for approval? Thanks so much.

Great. Thank you.

Yaron Werber: Great. Thank you.

Thank you next question that's from the line up.

Operator: Thank you. Next question is from the line of Yatin Suneja from Jefferies.

And that young from Guggenheim.

That's all the progress I'm just on the CIA DP trial.

Yatin Suneja: Congrats on all the progress. Just on the CIDP trial, number one, could you just comment on your expectation given that I think the data might be coming hopefully sometime next year? How much disclosure will you make when you make the decision to expand it? If you can comment on the relative size of CIDP, the current use of IVIG in MG versus CIDP, just to give a sense of how big that opportunity might be. Thank you.

One because you just comment on the or expectations given that.

Hopefully sometime next year, how much disclosure will you make when you made the decision to expand that.

Yaron Benjamin Werber: Great, thank you. Thank you. The next question is from the line of Yatin Suneja from Yogi 9.

And then also to can comment on the relative size of see I'd be decline to use of ideology.

Just to give a sense of how big that opportunity.

Thank you, yes, and thanks for being with US today. So we realize that the go no go decision point to and expands the phase two study into a Registrational study is a very significant data point for our shareholders and investors. So we plan to make that decision probably.

Yatin Suneja: Thank you for all the progress. Just on the CIDP trial, number one, could you just comment on your expectations given that I think the data might be coming, hopefully, sometime next year. How much disclosure will you make when you make the decision to expand it? And then also, if you can comment on the relative size of CIDP, the current use of IVIG and MG versus CIDP just to give a sense of how big that opportunity might be. Thank you.

Tim Van Hauwermeiren: Thank you, Yatin. Thanks for being with us today. We realize that the go/no-go decision point to expand the phase 2 study into a registrational study is a very significant data point for our shareholders and investors. We plan to make that decision public and also give some view on the data. We now guide that, you know, this data point is going to come in 2021. This study is enrolling, and actually, we're opening sites at a pretty high pace, but, you know, it's a demanding protocol. In terms of relative size, we think that CIDP is likely representing one of the bigger markets for efgartigimod.

And also give some view on the data.

We now see guidance you know the data point is going to come in in 2021.

Tim Van Hauwermeiren: Thank you Yatin, thanks for being with us today. We realize that the GoNoGo decision point to expand the Phase 2 study into a registrational study is a very significant data point for our shareholders and investors. So we plan to make that decision public and also give some views on the data, um, we now guide that you know this data point is going to come in in 2021. This study is enrolling, and actually we're opening sites at a pretty high pace, that you know it's a demanding protocol, in terms of relative size.

This study is enrolling.

And actually the opening sites at a pretty high pace, but you know, it's a demanding protocol and in terms of relative size, we think that C or D. P is likely representing one of the Bacon markets for Africa pick them up if you simply look at the chronic nature of the disease and the lifelong nature of the disease, Andy and reliance.

Tim Van Hauwermeiren: If we simply look at the chronic nature of the disease and the lifelong nature of the disease and the reliance mainly on IVIG, CIDP is basically a lifelong sentence to IVIG. Then we think that this is gonna be one of the more substantial markets. Remember that the IVIG sales in CIDP just in the United States on an annual basis is exceeding $1.5 billion.

Mainly on Ivy our G. CDP is basically a lifelong sentence to Ivy ajai than we think that this is going to be above the more substantial markets remember that the and Ivy EDG sales instead, if he just in the United States on an annual basis is exceeding 1.5 billion.

Tim Van Hauwermeiren: We think that CIDP is likely to represent one of the bigger markets for Epcraft-Tegelmods. If we simply look at the chronic nature of the disease and the lifelong nature of the disease and the reliance mainly on IVIG, CIDP is basically a lifelong sentence to IVIG, then we think that this is going to be one of the more substantial markets. Remember that the IVIG sales in CIDP just in the United States on an annual basis are exceeding 1.5 billion.

Well just let me quickly on the financial side can you just help us would be and would be spend going forward I saw the I'd be coming down a little bit in the quarter just help us understand how should we model gets from says.

Yatin Suneja: Great. Can you just maybe quickly on the financial side, can you just help us with the, with the spend going forward? I saw the R&D coming down a little bit in the quarter. Just help us understand how should we model the expenses, because I think G&A is picking up. Thank you.

Yes. Thank you.

Tim Van Hauwermeiren: Eric, would you like to take this question, please?

It it would you like to take this question. Please.

Tim Van Hauwermeiren: Eric, would you like to take this question, please?

Eric Castaldi: Sure. Absolutely, yeah. Indeed, there is a significant increase in our operating costs, as I said. Basically, we are not giving any guidelines on the cash burn, but what we can say is that we expect, as we continue to advance our late-stage pipeline, that the costs continue to go up quarter-over-quarter.

Absolutely.

So indeed, there is a significant increase in Oh operating cost as I said.

And the digitally.

Well, let giving any guidelines on the cash build but what we can see that so we expect.

Tim Van Hauwermeiren: Thank you very much.

As we continue to advance on late stage pipeline.

Not the costs continue to go.

So over the quarter.

Okay.

Erica Salde: Eric, would you like to take this question please? Sure, absolutely yes.

Yatin Suneja: Thank you.

Okay. The next question.

Erica Salde: So indeed, there is a significant increase in our operating costs, as I said, and basically, we are not giving any guidelines on the cash burn, but what we can say is that we expect, as we continue to advance our late-stage pipeline, that the costs will continue to go up quarter over quarter. Thank you.

Operator: Okay. The next question is from Jason Butler from JMP Securities.

Jason Butler from JMP Securities.

Hi, Thanks for taking the question just just had another one on who's a can you maybe talk about the or any of the safety data you have from culminate and I guess that in addition to from mechanistic perspective, how you think about the the safety and Tolerability in context of a triple combo with an eye.

Jason Butler: Hi. Thanks for taking the question. Just had another one on Cusa. Can you maybe talk about any of the safety data you have from CULMINATE? I guess that, in addition to from a mechanistic perspective, how you think about the safety and tolerability in context of a triple combo with venetoclax. Then, again, in terms of CULMINATE, is there enough data there to look at molecular subgroups or other biomarkers, or do biomarkers play into your strategy at all at this point? Thanks.

KLAX and then again in terms of culminate is there enough data there to look at molecular sub groups or other biomarkers or the biomarkers play into your strategy at all at this point. Thanks.

Jason Butler: Okay, the next question. It's from Jason Butler from JMP Security. Hi, thanks for taking the question.

Jason Butler: Just had another one on Kooza. Can you maybe talk about any of the safety data you have from Culminate, and I guess, in addition to from a mechanistic perspective, how you think about the safety and tolerability in the context of a triple combo with Venetoclax. And then again, in terms of Culminate, is there enough data there to look at molecular subgroups or other biomarkers, or do biomarkers play into your strategy at all at this point? Thanks.

Thank you Jason is two great question. So on the safety side, what we say today that whilst we going to disclose of course, a more detailed data early twentytwenty alone and we can say that the safety profile, we observe and culminates is consistent and in line with the earliest safety data so the safety profile.

Tim Van Hauwermeiren: Thanks to Jason. These are two great questions. On the safety side, what we say today is that while we're going to disclose, of course, more detailed data early 2021, we can say that the safety profile we observe in CULMINATE is consistent and in line with the earlier safety data. The safety profile of Cusa continues to look very promising. This is important because you're absolutely right. The Venclexta combination comes with some toxicity. While it's very potent in inducing CRs, the question is, how do you keep patients in CR? Safety is going to be a key aspect in any future combination going forward with what we think could be the future standard of care, which is venetoclax Venclexta. With regards to subset analysis, it's too early to comment on it, but it is possible.

Airlift Cusack continues to look very promising.

And this is important because you're absolutely right. The venessa combination and comes with some toxicity.

Tim Van Hauwermeiren: Thanks to Jason. These are two great questions.

And while it's very important and inducing CR. The question is how do you keep patients NCR. So safety is going to be a key aspect in any future combination going forward with what we think could be the fuchsia standard of care, which is the Venetoclax Fridays.

And with regards to subset analysis, it's too early to comment on it but it is possible of course within MLB have a very clear view on risk classification Sutter genetics.

Tim Van Hauwermeiren: So on the safety side, what we say today is that, whilst we're going to disclose, of course, more detailed data early in 2021, we can say that the safety profile we observe in culmines is consistent and in line with the earlier safety data. So the safety profile of CUSA continues to look very promising. And this is important because you're absolutely right.

Tim Van Hauwermeiren: Of course, within AML, we have a very clear view on risk classification, cytogenetics, some biomarkers. We will for sure try to further stratify the datasets coming out of CULMINATE, but we will have to be a little bit patient here because these data are of course still maturing.

Tim Van Hauwermeiren: The Venetha combination comes with some toxicity, and while it's very potent in inducing CRs, the question is, how do you keep patients in CRs? So safety is going to be a key aspect in any future combination going forward with what we think could be the future standard of care, which is Venetha-galactoside-Desa. And with regard to substance analysis. It's too early to comment on it, but it is possible. Of course, within AML, we have a very clear view on risk classification, cytogenetics, and some biomarkers. So we will definitely try to further stratify the data sets coming out of culmine, but we will have to be a little bit patient here because these data are, of course, still maturing.

Some biomarker so we will for sure tried to further satisfied the data sets are coming out of culminates.

But we will have to be little bit station team. Because these data are of course to the maturing.

Okay, Great. That's helpful. Thanks for taking my questions. Thanks, Jason.

Jason Butler: Okay, great. That's helpful. Thanks for taking the questions.

Tim Van Hauwermeiren: Thanks, Jason.

Thank you our next question.

Operator: Thank you. Our next question is from Akash Tewari from Wolfe Research.

Gosh, why do you from Wolfe research.

Right right not just had a question there wont be appeal allow you to run a basket trials for indications that are predominantly driven by pathogenic I keep but may have low prevalence for example.

Akash Tewari: First, the efgartigimod. Just had a question there. Would the FDA allow you to run a basket trial for indications that are predominantly driven by pathogenic IgG, but may have low prevalence, for example, Miller Fisher syndrome or Goodpasture syndrome? And could you possibly do this in larger indications as well? Thank you.

Those are some gemma good Patterson gems in could you, possibly do this larger indication the cloud. Thank you.

Jason Butler: Okay, great. That's helpful.

Akash Tewari: Thanks for taking the questions. Thanks, Jason. Thank you. Our next question is from Akash Tewari from World Food Search.

And this is this is a good question and it's a question, which we entertain internally in the company and we believe that after having proven the concept.

Tim Van Hauwermeiren: Yeah, this is a good question, and it's a question which we entertain internally in the company. We believe that after having proven the concept a number of times in the current indications where we're playing, we will be in a position to turn around and have that conversation with the FDA. I think especially for indications which are very high unmet need, clearly mediated by pathogenic IgGs, and probably too small or unethical to do a placebo-controlled or controlled randomized study. This is something which we have on our regulatory to-do list, but we believe that the time is only right to do that if and when we have established proof of concept a number of times.

Akash Tewari: Would the FDA allow you to run a basket trial for indications that are predominantly driven by pathogenic IgG but may have a low prevalence, for example, Miller-Fisher syndrome or Goodpasture syndrome? And could you possibly do this in larger indications as well? Thank you.

A number of times in the current indications will be playing we will be in a position to turnarounds and have that conversation with the FDA I think especially for indications, which are very high unmet need.

Clearly mediated by pathogenic hydrogenase, and probably too small or an ethical to do a placebo controlled or controlled randomized studies. So this is something which we have on our regulated to do this but to be believed at the time is only arrived to do that if and when we have established proof of concept in number of times.

Tim Van Hauwermeiren: This is a good question, and it's a question that we entertain internally in the company. We believe that after having proven the concept a number of times in the current indications where we're playing, we will be in a position to turn around and have that conversation with the FDA. I think especially for indications which are very high in need, are clearly mediated by pathogenic IgGs, and are probably too small or unethical to do a placebo-controlled or controlled randomized study. So this is something which we have on our regularly to-do list. But we believe that the time is only right to do that, even when we have established proof of concept a number of times.

Thank you. Thank you.

Akash Tewari: Great. Thank you.

Tim Van Hauwermeiren: Thank you.

Thank you next question would be Matthew Harrison from Oregon.

Operator: Thank you. Next question will be Matthew Harrison from Morgan Stanley.

Hi, This is Mac score on for Matthew Harrison I'm, just a quick question regarding the CIA DP delayed do you view this primarily as related to cope with 19 or a lot of these patients hesitant to complete a washout period and also could you talk about how you think.

Max Goral: Hi. This is Max Goral for Matthew Harrison. Just a quick question regarding the CIDP delay. Do you view this primarily as related to COVID-19, or are a lot of these patients hesitant to complete a washout period? Could you talk about how you're thinking about the timing around the European application for efgartigimod? Thank you very much.

Max Skor: Hi. This is Max Goral for Matthew Harrison. Just a quick question regarding the CIDP delay. Do you view this primarily as related to COVID-19, or are a lot of these patients hesitant to complete a washout period? Could you talk about how you're thinking about the timing around the European application for efgartigimod? Thank you very much.

Akash Tewari: Great, thank you. Thank you.

Operator: Thank you.

About the timing around the European application for F. Kartik month, Thank you very much.

Matthew Harrison: Thank you. The next question will be Matthew Harrison from Arkansas. Hi, this is Max Skoron from Matthew Harrison's University.

I will take the first question will share. The PM, then I will hand over to keep on the European registration, but this is a good question mex. Thank you the shared the P. timeline is totally driven by corporate 19. So.

Tim Van Hauwermeiren: I will take the first question on CIDP, and then I will hand over to Keith on the European registration. This is a good question, Max. Thank you. The CIDP timeline is totally driven by COVID-19. The level of enthusiasm we see for the drug candidates, its mode of action, and for the protocol remains high. We do not see any issues in getting sites enthusiastic about the clinical trial or physicians. I think the sites which are open actually are successful in identifying and screening patients. That does not seem to be the problem. I think the protocol is a workable protocol. It's mainly the COVID-19 situation which is in play in this delay. Keith, would you mind addressing the European registration path question?

Matthew Harrison: Just a quick question regarding the CIDP delay. Do you view this primarily as related to COVID-19? Or are a lot of these patients hesitant to complete a washout period? And also, could you talk about how you think about the timing around the European application for EPCARD-Tigamod? Thank you very much.

The level of at this Hasnt received for the drug candidates its mode of action and for the protocol remains high as we do not see any issues in getting five cents a skeptic about de clinical trial of physicians and I think the as sites, which are open actually have successful in identifying and screen.

Tim Van Hauwermeiren: I will take the first question on CIDP, and then I will hand over to Keith on European registration. But this is a good question, Max, thank you.

An inpatient so that does not seem to be the problem I think the protocol.

Tim Van Hauwermeiren: The CIDP timeline is totally driven by COVID-19, so the level of enthusiasm we see for the drug candidates, their mode of action, and for the protocol remains high. We do not see any issues in getting sites enthusiastic about the clinical trial of physicians, and I think the sites which are open actually are successful in identifying and screening patients. So that does not seem to be the problem. I think the protocol is a workable protocol. It's mainly the COVID-19 situation which is in play in this delay. Keith, would you mind addressing the European registration path question?

A workable protocol, it's mainly to covert 19 situation, which is in play individually.

It would you mind addressing the European registration path question.

Sure happy to Tim.

Keith Woods: Sure. Happy to, Tim. Well, first of all, our priority, as you know, is the US and then Japan. We currently are in the process, in the final stages of hiring a European GM, and we are outlining our strategy in Europe. This will likely be a staged approach, as we determine the process of approaching the EU big five, but also how we will expand beyond there. We have the opportunity to expand our supply chain to accommodate the additional geographies. The bottom line is internally, we are working towards an EMA submission.

Well first of all our priority as you know is the U.S. and then Japan.

We currently are in the process in the final stages of hiring a European GM.

And we are outlining our strategy in Europe. This will likely be a staged approach as we determine the process of.

Approaching the big five but also how we will expand beyond there.

We have the opportunity to expand our supply chain to accommodate the additional geographies.

Keith Woods: First of all, our priority, as you know, is the U.S. and then Japan. We are currently in the process, in the final stages, of hiring a European GM, and we are outlining our strategy in Europe. This will likely be a staged approach as we determine the process of approaching the EU Big Five but also how we will expand beyond there. We have the opportunity to expand our supply chain to accommodate the additional geography. The bottom line is that internally, we are working towards an EMA submission.

The bottom line is internally, we're working for we're working towards an M. A submission.

Great. Thank you.

Tim Van Hauwermeiren: Great. Thank you.

Yeah.

Operator: Thank you. Our next question is from the line of June Lee from Santander. If so, when can we expect an update there? And I have a follow-up.

Operator: Thank you. Our next question is from the line of June Lee from Santander.

Thank you. Our next question, it's wrong, but I know joon Lee from Suntrust.

Yeah.

Okay.

Yes.

Matthew Harrison: Great. Thank you. Thank you. Our next question is from the line of Joon Lee from SunTrust. [inaudible] And if so, when can we expect an update there? And we'll have a follow-up.

If so internally, but they're not big bear and I've a follow.

June Lee: If so, when can we expect an update there? And I have a follow-up.

Hey, good could be repeated question because we missed the first part of the question you were probably still on mute.

Tim Van Hauwermeiren: Hey, June, could we repeat the question because we missed the first part of the question. You were probably still on mute.

Oh, okay. So.

Operator: Oh, okay. You know, cusatuzumab, CD70 is becoming a very popular target, and others are targeting CD70 for solid tumors and T-cell malignancies. Do you or J&J have plans to expand beyond AML, and if so, when can we expect an update there?

June Lee: Oh, okay. You know, cusatuzumab, CD70 is becoming a very popular target, and others are targeting CD70 for solid tumors and T-cell malignancies. Do you or J&J have plans to expand beyond AML, and if so, when can we expect an update there?

To the to snap Cseven is becoming a very popular target and others are targeting 60, 70 for solid tumors and T cell malignancies. So do you or changes may have plans to expand beyond email and if so they can we expect an upbeat there.

I think you're absolutely right than ineffective Cdseventy is on the radar screen and in solid tumors. We do know that Cdseventy and is often the heavily over express, but we don't understand the disease biology, which is involved in that that is the big difference with the leukemias and which caught out interest because.

Tim Van Hauwermeiren: I think you're absolutely right in the fact that CD70 is on the radar screen. In solid tumors, we do know that CD70 is often heavily overexpressed, but we don't understand the disease biology which is involved in that. That is the big difference with the leukemias which caught our interest because, thanks to the work of Professor Ossenkoppele from the Bern University Hospital. We do understand the involvement of the CD70, CD27 pathway in the survival and proliferation of leukemic stem cells. Remember that we also ventured into T-cell lymphoma at the start of the program, and we did dose escalation in phase I. We did see some pretty spectacular responses in T-cell lymphoma, and we did do an expansion cohort in T-cell lymphoma.

Joon So Lee: Hey Joon, could we repeat the question? Because we missed the first part of the question; you were probably still on mute.

Joon So Lee: Oh, okay. So, you know, Kuva Tuzumab, CD70 is becoming a very popular target, and others are targeting CD70 for solid tumors and T cell malignancies. So do you or J&J have plans to expand beyond AML? And if so, when can we expect an update there?

There thanks to the work of Professor Ochsenbine from the Burn University Hospital, we do understand the involvement of the Cdseventy Cdtwenty seven pathway in the survival and proliferation of leukemic stem cells.

Tim Van Hauwermeiren: Yeah, I think you're absolutely right about the fact that CD70 is on the radar screen. In solid tumors, we do know that CD70 is often heavily overexpressed, but we don't understand the disease biology which is involved in that. That is the big difference with the leukemias, which caught our interest because there, thanks to the work of Professor Oxenbein from the Bern University Hospital, we do understand the involvement of the CD70, CD27 pathway in the survival and proliferation of leukemic stem cells. Remember that we also ventured into T-cell lymphoma at the start of the program, and we did escalation in phase one. We did see some pretty spectacular responses in T-cell lymphoma, and we did do an expansion cohort in T-cell lymphoma.

Remember that we also ventured into T cell lymphoma and at the start of the program and we did dose escalation phase one we did see some pretty spectacular responses in T cell lymphoma, and we didn't do an expansion scored in T cell lymphoma, we achieved about a 30% overall response rate so very long responses.

Tim Van Hauwermeiren: We achieved about a 30% overall response rate with some very long responses in T-cell lymphoma. Basically, we were judging at that point in time that this was insufficient to take the molecule forward in T-cell lymphoma. In general, lymphomas are part of the Janssen global development plan, but they will clearly follow in sequence after the work we plan to do in AML and high-risk MDS. These two indications are prioritized in their global development plan.

T cell lymphoma, basically be but judging at that point in time, but this was insufficient to take the molecule forward and T cell lymphoma.

In general inform us are part of the Janssen Global development plan, but they will clearly following sequence after and to work we plan to do in AML and high risk Mds. So these two indications are prioritized in that global development plan.

Tim Van Hauwermeiren: We achieved about a 30% overall response rate with some very long responses in T-cell lymphoma, but basically, we were judging at that point in time that this was insufficient to take the molecule forward in T-cell lymphoma. In general, the formats are part of the Janssen Global Development Plan, but they will clearly follow in sequence after the work we plan to do in AML and high-risk MDS. Hence, these two indications are prioritized in the Global Development Plan.

Operator: Okay. Your indications outside of lymphoma and AML are yours to control?

June Lee: Okay. Your indications outside of lymphoma and AML are yours to control?

Okay.

But but so you indicated outside of lymphoma, and ammo are yours to control.

We have nothing specific on that in the global development plan I think what we said in public is first and Mylan high risk. Mds, then is the potential to ventured into lymphoma.

Tim Van Hauwermeiren: We have not been specific on that in the global development plan. I think what we said in public is first is AML and high-risk MDS. Then is the potential to venture into lymphomas and other indications, but we have not said anything specific about solid tumors.

Well the indications, but we have not sell anything specific about a solid tumors.

Operator: Great. Okay, so just another question. For your 117 study in COVID-19, how many patients do you need to treat to get comfortable around efficacy? Because others have treated as little as 10 patients with COVID-19 ARDS and got sufficient conviction to move into a pivotal trial. What's your bar for advancing in COVID-19 ARDS?

June Lee: Great. Okay, so just another question. For your 117 study in COVID-19, how many patients do you need to treat to get comfortable around efficacy? Because others have treated as little as 10 patients with COVID-19 ARDS and got sufficient conviction to move into a pivotal trial. What's your bar for advancing in COVID-19 ARDS?

Great. Okay. So just another question for you or 1.7 studying Colgate 19, how many patients do you need to treat to get comfortable around efficacy because others have treated as littlest pet patients I would coping 19, argenta and got sufficient condition to move into a pivotal trial. So what's your Bart for advancing in Cold 19 Arts.

Joon So Lee: But so your indications outside of lymphoma and AML are yours to control?

Tim Van Hauwermeiren: We have not been specific on that in the global development plan, but I think what we said in public is.

Tim Van Hauwermeiren: First, AML and highly scanned DS have the potential to venture into lymphomas and other indications, but we have not said anything specific about solid tumors.

Remember that the this is a phase one studies. So we have never been in human subjects with 117 before so actually we need to do two things in this phase form the first thing we need to do is dose escalate.

Tim Van Hauwermeiren: Remember that this is a phase I study. Actually we have never been in human subjects with one seventeen before. We need to do two things in this phase I. The first thing we need to do is dose escalate and establish the right dose. That means the dose which is completely knocking out C2, and then we need to establish signs of efficacy. I think of a number of patients which would be typical for a classical dose escalation, although the regulator allows us to test to dose escalate in somewhat bigger steps given the urgency of the situation. Then you're right. I mean, in order to establish activity or an evidence of activity, you're talking about a similar number of patients, you know, around 10.

Joon So Lee: For your 117 study in COVID-19, how many patients do you need to treat to get comfortable around efficacy? Because others have treated as few as 10 patients with COVID-19Rs and got sufficient conviction to move into a pivotal trial.

And the suddenly the right dose that means the dose which is completely and looking out to two and then we need to establish the signs of efficacy. So I think think of a number of patients which would be typical for a classical dose escalation.

Although the regulator allows us to test to dose escalating so were bigger steps given the urgency of the situation, but then you're right I mean in order to establish an activity or an evidence of activity you're talking about a similar number of patients you know around 10.

Tim Van Hauwermeiren: Remember that this is a phase 1 study, so we have never been in human subjects with 117 before.

Tim Van Hauwermeiren: So actually, we need to do two things in phase 1. The first thing we need to do is dose escalate and establish the right dose. That means the dose which is completely knocking out C2. And then we need to establish signs of efficacy. So think of a number of patients which would be typical for a classical dose escalation, although the regulator allows us to dose escalate in somewhat bigger steps given the urgency of the situation. But then you're right. I mean, in order to establish activity or evidence of activity, you're talking about a similar number of patients, you know, around 10.

Okay. Thank you.

Operator: Great. Thank you.

June Lee: Great. Thank you.

Tim Van Hauwermeiren: Thank you.

Yeah.

Thank you. Our next question it's from the line up of gene and I've been asked a question.

Operator: Thank you. Our next question, it's from the line of Tazeen Ahmad. You may ask your question.

Dave.

That's already been I, just thought will now cannot leaning on type thing or four and he can you just good job and in outlet general range of what payers are I'm, saying that they would be receptive to at the same kibali that that.

Tazeen Ahmad: That's already been asked, just let me know. Tim, maybe on pricing for MG, can you just and you know a general range of what payers are saying that they would be receptive to at this stage? You've always said that you would be very competitive with the current market and how you wanna price efgartigimod for MG. As a point of comparison, can you give us an idea of how much annually it costs for a patient in the US to take IVIG? Then I have a follow-up on CIDP. Thanks.

Joon So Lee: Thank you. Thank you. Our next question is from the line of Tazeen Ahmad. You may ask your question.

Like E I'm very competitive, but the current market and how you want to price that's gonna take them Oh for Angie and as a point of comparison can you give us an idea of how much annually.

Tazeen Ahmad: That's already been asked; just let me know. Tim, maybe on pricing for MG, can you just suggest an end price, you know, a general range of what payers are, I mean, they would be receptive to at this stage. You've always said that you would be very competitive with the current market and how you want to price Edgar Tiggemont for MG. And as a point of comparison, can you give us an idea of how much annually it costs for a patient in And then I have a follow-up on CIDP. Thanks.

For P sand in the U.S. take ideology, and then I have a follow up on okay.

Thank you I keep why don't you go ahead and you take the question on pricing and the annualized cost of Ivy Igene Mg and then I will probably take on the next question Okay.

Tim Van Hauwermeiren: Thank you. Keith, why don't you go ahead and you take the question on pricing and the annualized cost of IVIG and MG, and then I will probably take on the next question. Okay?

Okay that sounds good as you know we are doing the homework on two fronts first of all as the current market dynamics and also the value that up starting March and bring the Mg patients.

Keith Woods: Okay. That sounds good. As you know, we are doing the homework on two fronts. First of all, is the current market dynamics and also the value that efgartigimod can bring to the MG patients. You know that at the high end of the spectrum in US, we have Soliris with a price tag of about $700,000 a year. We've learned from chronic IVIG patients that the annual therapy for them is around $140,000 a year. There's a lot of flexibility in pricing with MG, but we also wanna make sure that we are responsible as efgartigimod being a pipeline and a product.

You know that at the high end of the spectrum in U.S., we have Solaris, where the price tag of about $700000 a year.

Keith Woods: Thank you. Kiet, why don't you go ahead and take the question on pricing and the annualized cost of IVF gene energy, and then I will probably take on the next question. Okay. Okay.

We've learned from chronic.

Patients that the annual therapy for them is around $140000 a year. So there's a lot of flexibility in pricing with them G. But we also want to make sure that we're responsible as.

Keith Woods: Okay, that sounds good. As you know, we are doing homework on two fronts.

As I've got my being a pipeline on a product.

Keith Woods: First of all, it's the current market dynamics and also the value that the F30 mod can bring to the MG patient. You know that at the high end of the spectrum in the U.S., we have Solaris with a price tag of about $700,000 a year. We've learned from chronic IBIG patients that the annual therapy cost for them is around $140,000 a year. So there's a lot of flexibility in pricing with MG. But we also want to make sure that we are responsible as, as Hefgardigamad is a pipeline and a product.

It.

Tim Van Hauwermeiren: Tazeen, did you have a second question, please?

It does seem to have a second question. Please.

Oh I'm sorry, I wanted to just also asked you about HM.

Tazeen Ahmad: Oh, I'm sorry. I wanted to just also ask you about CIDP. How is this indication potentially different in terms of the heterogeneity of the patient population, let's say, relative to MG? How does that make the challenge of determining if it's worth moving forward in this indication viable or not? Secondly, let's say another, you know, company is able to get to market before you for CIDP, if you do choose to move forward, how much is where you would be in the competitive landscape in terms of when you would enter the market gonna be a decision in deciding whether to move forward in this indication or not?

Hello.

Jason potentially their friends in times of the heterogeneity in prison population that they relative to engineered how does that make the challenge and determining it at work moving forward on listen Dickinson viable or not.

And then separately, let's say another company they bought the they got some market for you for first Yankee P.T.K. to look forward. How much is where you would be the competitive landscape in terms of when you're going after them I don't want to be asked that question on deciding whether to move forward and nothing to kiss.

Keith Woods: Tazeen, did you have a second question, please?

Tazeen Ahmad: Oh, I'm sorry. I wanted to also ask you about CIDP. How is this indication potentially different in terms of the heterogeneity of the patient population, let's say relative to MG, and how does that make the challenge of determining if it's worth moving forward in this indication viable or not? And then secondly, let's say another company is able to get to market before you for CIDP; if you do choose to move forward, how much is where you would be in the competitive landscape in terms of when you would enter the market going to be a decision in deciding whether to move forward in this indication or not?

In or not.

Well, you're noticing that said the piece is a big indication with very limited tools being the therapeutic toolkit. So.

Tim Van Hauwermeiren: Well, you know, Tazeen, that CIDP is a big indication with very limited tools in the therapeutic toolkit. A CIDP patient today would be mainly treated with steroids and IVIG. There's not much other optionality out there. Even if there would be a couple of players entering this space, I think this space is pretty much wide open. You are right in pointing out the heterogeneity for CIDP, which is true by the way, for so many autoimmune indications. I think some of the confusion comes from the fact that certain people which are labeled as a CIDP patient and are being prescribed IVIG as being CIDP patients are maybe not CIDP patients after all. That's something which we learned from the homework we did when we were designing the phase 3 trial.

Yeah, the patient today would be mainly treated with steroids and and Ivy Angie.

There's not much older Optionality out there so even if there would be a couple of place and entering this space I think the space. This is pretty much white oak.

You are right in pointing out the heterogeneity associated D, which is true by the way for so many autoimmune indications and I think some of the confusion comes from the fact that certain people, which are labeled as a C or D. P patients and are being prescribed ideology as being CDP patients or maybe not CRT P based.

Tim Van Hauwermeiren: Well, you know Tazeen that CIDP is a big indication with very limited tools in the therapeutic toolkits, so a CIDP patient today would be mainly treated with steroids and IVIG. There's not much other optionality out there, so even if there would be a couple of players entering this space, I think this space is pretty much wide open. You are right in pointing out the heterogeneity for CIDP, which is true, by the way, for so many autoimmune indications, and I think some of the confusion comes from the fact that certain people who are labeled as CIDP patients and are being prescribed IVIG as being CIDP patients are maybe not really CIDP patients after all. That's something which we learned from the homework we did when we were designing the phase 3 trial, and that's why we also borrowed the concept of having an independent board of CIDP specialists, which validates the diagnosis of CIDP before the patient can actually enroll in the trial.

After all.

That's something that should be learn from the homework, but it wouldn't be we're designing the phase three trial and that's why we also bought off a concept.

Tim Van Hauwermeiren: That's why we also borrowed the concept of having an independent board of CIDP specialists, which validates the diagnosis of CIDP before the patient can actually enroll to the trial. We need to weed out non-CIDP patients from the trial to make sure that we are effectively treating CIDP. Indeed, you see that within CIDP, there are different subsets of patients if you would try to classify them based on the nature and identity of their autoantibody. Now, we believe that all these true CIDP patients do have autoantibodies of the IgG type, as was evidenced in the R&D day by means of the plasma exchange and, more importantly, the immunoadsorption data. That is the beauty of efgartigimod. It does not matter where your autoantibody binds or what it does.

Having an independent.

Boards of said, the P. specialist, which validates the diagnosis of Cndp before the patient can actually enrolled to the trial, so we need to read out.

Non CKD patients from the trial to make sure that we had effectively treating said it'd be.

And then in did you see that within CTP and there are different subsets of patients. If you would try to classify them based on the nature of an identity of that old antibody.

We believe that all these through CDP patients do have also antibodies have the ajai type as was evidenced in the R&D day.

By means of above mix change and more importantly, D imminent swaption data and that is the beauty of adopting them off it does not method, where your auto antibody binds or what it does as long as it is an idea GE molecule, we will clean it with regards mode of action. So I think with the 30 patients.

Tim Van Hauwermeiren: So we need to weed out non-CIDP patients from the trial to make sure that we are effectively treating CIDP. And then, indeed, you see that within CIDP there are different subsets of patients if you try to classify them based on the nature and identity of their autoantibodies. Now we believe that all these true CIDP patients do have autoantibodies of the IgG type, as was evidenced in the R&D day by means of the plasma exchange, and more importantly, the immune adsorption data. And that is the beauty of Avgar-TigaMod. It does not matter where your autoantibody binds or what it does. As long as it is an IgG molecule, we will clear it with Avgar's Motivax. So, I think with the 30 patients go no-go decision point, we will have a pretty clear handle on, you know, what the likely subset of patients in which we can play and whether this heterogeneity is playing a role at all if you try to treat them with an F-card tigma.

Tim Van Hauwermeiren: As long as it is an IgG molecule, we will clear it with efgartigimod's mode of action. I think with the 30 patients go no go decision point, we will have a pretty clear handle on, you know, what is the likely subset of patients in which we can play and whether this heterogeneity is playing a role at all, if you try to treat them with efgartigimod.

Go No go decision point, you will have a clean handle on you know what is the likely subset of patients in which we can play and whether this heterogeneity is playing a role at all if you try to treat them with an effective.

And then shallow and is there anything that makes it difficult to enroll people. So it does that for example, <unk> <unk>. Your competitor and then also said that there are tile it sounds like that's a cold and wet laid up or are there other alison.

Tazeen Ahmad: In general, Tim, is there anything that makes it difficult to enroll CIDP patients? It does seem that, for example, your competitor, UCB, did also say that their trial has been delayed. Is it just COVID-related or are there other issues?

But we cannot speak foot somebody else's trial that will be experiences its really corbett.

Tim Van Hauwermeiren: Well, we cannot speak for somebody else's trial, but what we experience is it's really COVID. We try to enroll patients in Japan, Europe, and United States. This is already global from the get-go. What you see is that really on a country-by-country and even side-by-side basis, COVID has kept the medical community very busy. I think we are now really ramping up the number of sites which we're opening. As I said before in the call, those sites which are open actually don't find it difficult to identify patients and screen patients. We're pretty optimistic that if COVID remains under control, that's a big if, and these sites which we are opening will be successfully enrolling the trial.

We try to enroll patients in Japan, Europe, and the United States. This is this is already global from the get go and what you see that really on the country by country and even side by side basis covert has kept the medical community very busy.

Tazeen Ahmad: And then, in general, Tim, is there anything that makes it difficult to enroll CID patients? It does seem that, for example, your competitor, UCB, did also say that their trial has been delayed. Is it just COVID-related, or are there other issues?

So I think we now really ramping up the number of science, which we are opening and as I said before in the call those sites, which are open actually don't find it difficult to identify patients on screen patients. So we're pretty optimistic that if coolfit remains under control that's a big if and decided to get opening will be successfully enrolling the trial.

Tim Van Hauwermeiren: Well, we cannot speak for somebody else's trial, but what we've experienced is it's really COVID. We try to enroll patients in Japan, Europe, and the United States. This is already global from the get-go.

Tazeen Ahmad: And what you see is that, really, country-by-country and even side-by-side, COVID has kept the medical community very busy. So, I think we are now really ramping up the number of sites which we are opening. And as I said before on the call, those sites which are open actually don't find it difficult to identify patients and screen patients. So, we are pretty optimistic that if COVID remains under control, that's a big if, and these sites which we are opening will be successfully enrolling patients in the trial.

Now.

Okay.

Tazeen Ahmad: Okay. Thank you.

Tim Van Hauwermeiren: Mm-hmm.

Thank you. Our next question is from the line of Servanda Becky.

Operator: Thank you. Our next question is from the line of Greg Svanovich.

Right.

Hi, Good morning, and good afternoon can you hear me okay.

Greg Svanovich: Greg, good morning and good afternoon. Can you hear me okay?

Graig Suvannavejh: Greg, good morning and good afternoon. Can you hear me okay?

Tim Van Hauwermeiren: Yeah, we can.

Yes, we can.

Okay, Great I've got two questions, please and they're all around.

Greg Svanovich: Okay, great. I've got two questions, please, and they're all around efgartigimod. Just first, in the myasthenia gravis Phase 3 study, you talk about 40% minimal symptom expression. I just wanted to ask a question about that. You know, we've done some work with KOLs who said, you know, in their personal opinion, while 40% is good, you know, they might have been hoping that for maybe 50% or 60% would be perhaps something that would be better. Can you put the 40% MSE in context? Just wanted to get some color on that.

Graig Suvannavejh: Okay, great. I've got two questions, please, and they're all around efgartigimod. Just first, in the myasthenia gravis Phase 3 study, you talk about 40% minimal symptom expression. I just wanted to ask a question about that. You know, we've done some work with KOLs who said, you know, in their personal opinion, while 40% is good, you know, they might have been hoping that for maybe 50% or 60% would be perhaps something that would be better. Can you put the 40% MSE in context? Just wanted to get some color on that.

Ask our ticket much just first come.

In the Miocene aground vis a phase three study you talked about.

Tim Van Hauwermeiren: Okay, thank you.

40%, a minimal symptom expression I just wanted to ask a question about that and we've done some worked with Kao wells, who said in their personal opinion, while 40% is good they might have been hoping that for maybe 50 or 60% would be perhaps something.

Shirey Dzivanovic: Thank you. Our next question is from the line of Shirey Dzivanovic. Okay, good morning and good afternoon. Can you hear me okay? Yeah, we can. Okay, great. I've got two questions, please, and they're all around Escartigamad.

Shirey Dzivanovic: Just first, in the myasthenia gravis phase 3 study, you talk about 40% minimal symptom expression. I just wanted to ask a question about that. We've done some work with KOLs who said, you know, in their personal opinion, while 40% is good, they might have been hoping that maybe 50 or 60% would be something that would be better. So can you put the 40% MSC in context? So just wanted to get some color on that. And then the second question I have is, you know, with the phase 3 data behind you, and as we look at next eschar-tigamod data events, given COVID-19, are you able to provide us with at least current expected timelines for your various readouts, whether they be next data sets in ATP, pemphigus, and CIDP? Thank you.

That would be better so can you put a 40% MSC and in context.

So just wanted to get some color on that and then the second question I have is you know with the phase three data behind you and as we look at next Escarcega much.

Greg Svanovich: The second question I have is, you know, with the Phase 3 data behind you, and as we look at next, efgartigimod, data events, given COVID-19, are you able to provide us with at least current expected timelines on your various readouts, whether they be, next data sets in ITP, pemphigus, and CIDP? Thank you.

Graig Suvannavejh: The second question I have is, you know, with the Phase 3 data behind you, and as we look at next, efgartigimod, data events, given COVID-19, are you able to provide us with at least current expected timelines on your various readouts, whether they be, next data sets in ITP, pemphigus, and CIDP? Thank you.

Data events, given covert 19 are you able to provide us with at least current expected timeline on your various read outs, whether they be.

Next datasets and ATP, a 10th I guess and C.I.D. peak. Thank you.

Thanks. Thank you for these two quick questions I will give the first question to keeping the minutes to contextualize, the 40% minimum symptom expression because of course, we have been very busy and learning about our data from the community.

Tim Van Hauwermeiren: Thank you for these two great questions. I will give the first question to Keith in a minute to contextualize the 40% minimum symptom expression because, of course, we have been very busy learning about our data from the community. But on your second question, no matter how much I would like it is not possible yet to give you clear guidance on when exactly these studies are gonna read out for the simple fact that COVID is not gone. I think we're still battling COVID big time in the United States. Let's touch wood, but for the moment in Japan and big parts of Europe, it seems to be under control. Now we're looking at a second wave of COVID, which is approaching us.

But on your second question no matter, how much I would like it it is not possible yet to give you clean guidance on when exactly. These studies are going to read out. So for the simple fact that covert has not gone I think we still battling cool, but a big time in the United States.

Keith Woods: Thank you for these two great questions. I will give the first question to Keith in a minute to contextualize the 40% minimum symptom expression because, of course, we have been very busy learning about our data from the community. But on your second question, no matter how much I would like it, it is not possible yet to give you clear guidance on when exactly these studies are going to be released, for the simple fact that COVID is not gone. I think we're still battling COVID a big time in the United States. Let's touch wood, but for the moment, in Japan and big parts of Europe, it seems to be under control. But now we're looking at a second wave of COVID, which is approaching us.

Lets touch wood, but for the moment in Japan, and big parts of Europe, It seems to be able to control, but now I mean, we're looking at a second wave of corporate which is approaching us. So it's it's split it goes to give you any reliable forecast you know on when executive studies would read out but I hope you agree with me today just.

Tim Van Hauwermeiren: It's pretty difficult to give you any reliable forecast, you know, on when exactly these studies would read out. I hope you agree with me that today, just like we did in the Q1 call, we try to give you a fully transparent look on the studies and where we are. Actually, we will continue to do that in the next quarters so that we can keep you closely abreast of, you know, the COVID situation. With that being said, Keith, would you mind contextualizing the 40% minimum symptom expression, please?

But it into Q1 call. We tried to give you a fully transparent look on the studies, where we are and actually we will continue to do that in the next quarters. So that we can keep you close the breadth of you know the corporate situation with that being said Keith would would you mind contextualizing the at 40% minimum symptom, especially.

Keith Woods: So it's pretty difficult to give you any reliable forecast, you know, on when exactly these studies will read out. But I hope you agree with me that today, just like we did in the Q1 call, we tried to give you a fully transparent look at the studies and where we are. And actually, we will continue to do that in the next courses so that we can keep you closely abreast of, you know, the COVID situation. With that being said, Keith, would you mind contextualizing the 40% minimum symptom expression, please?

And please.

Sure happy to.

Keith Woods: Sure. Happy to. Actually, when we've shared this data with our investigators and with other physicians in market research, they've been impressed with the 40% and found it quite compelling because this is so meaningful to patients. I also wanna remind you that this was a measurement after one cycle. This was four doses of efgartigimod, and we obtained that 40% MSE. We'll continue to look at it in subsequent cycles and see where the numbers go from there. We were quite encouraged that after only four doses to have that type of a MSE number.

Actually it when we've shared this data or with our investigators and with other physicians in market research they've been impressed with the 40% and found it quite compelling because this is so meaningful to patients I also want to remind you that this was a measurement. After one cycle. So this was four doses of F. Garda Mod and.

Keith Woods: Sure, happy to. Actually, when we shared this data with our investigators and with other physicians doing market research, they were impressed with the 40% and found it quite compelling because this is so meaningful to patients. I also want to remind you that this was a measurement after one cycle. So this was four doses of F-cardigomod, and we obtained that 40% MSC. We will continue to look at it in subsequent cycles and see where the numbers go from there. But we were quite encouraged that after only four doses we had that type of MSC number.

We obtained that 40% MSC.

We'll continue to look at it in subsequent cycles and see where the numbers go from there but.

We're quite encouraged that after only four doses to have that type of Oh MFC number.

Okay. Thanks, Keith and just one follow up Tim just on your comments I appreciate that it's very difficult to give guidance on on the timing of that read outs, but.

Greg Svanovich: Okay. Thanks, Keith. Just one follow-up, Tim, just on your comment. I appreciate that it's very difficult to give guidance on the timing of the readouts. Maybe given your visibility into where your studies are, is there perhaps one of those studies that is closer to being fully enrolled, where that might give an indication of kind of what could be next, even though you might not be able to provide exact, you know, timing?

Graig Suvannavejh: Okay. Thanks, Keith. Just one follow-up, Tim, just on your comment. I appreciate that it's very difficult to give guidance on the timing of the readouts. Maybe given your visibility into where your studies are, is there perhaps one of those studies that is closer to being fully enrolled, where that might give an indication of kind of what could be next, even though you might not be able to provide exact, you know, timing?

Maybe given your visibility into where Youre studies are is there perhaps one of those studies that is closer to being fully enrolled.

Where that might give an indication of kind of what could be next.

Even though you might not be able to provide exact.

You know timing.

No we're not in a position to give any common them, that's and I also don't think it would be appropriate.

Tim Van Hauwermeiren: No, we're not in a position to give any comment on that. I also don't think it would be appropriate. I think we need to continue to work hard on enrolling the trials and then look you know for reasonable updates in the next quarters to come.

Shirey Dzivanovic: Okay, thanks, Keith. And just one follow-up, Tim, on your comments: I appreciate that it's very difficult to give guidance on the timing of the readouts. But maybe, given your visibility into where your studies are, is there perhaps one of those studies that is closer to being fully enrolled, where that might give an indication of kind of what could be next, even though you might not be able to provide exact, you know, timing?

I think we need to we need to continue to work hard on a rolling the trials.

And then look you know for reasonable updates in the next quarters to come.

Okay, Alright, thank you very much I too.

Greg Svanovich: Okay. All right. Thank you very much.

Graig Suvannavejh: Okay. All right. Thank you very much.

Tim Van Hauwermeiren: Thank you.

Our next question, it's probably a line of Sandra column.

Operator: Our next question is from the line of Sandra Cauwenberghs from KBC Securities. Thank you.

Can you just thank you.

Tim Van Hauwermeiren: No, we're not in a position to give any comment on that, and I also don't think it would be appropriate. I think we need to continue to work hard on enrolling the trials, and I'm looking out for reasonable updates in the next quarters.

Yes, hi, Thanks, what do you have today types can I have one small question that it's more around takes its for clarification with regard to the 'cause that's isn't my follow up trial.

Sandra Cauwenberghs: Yes. Hi. Thanks for the update. I still have one small question left. It's for clarification with regard to the cusatuzumab follow-up trial. So what I understood is that you will do a triple combination. But I want to understand, will you be able to generate some data on a double combination of cusa and venetoclax in terms of safety data, adverse events popping up on the combination of these two drugs in particular?

<unk>, what I understood is that he will do a triple combination.

But I want to understand where you'll be able to generate some data on the on the double combination of cars and you need to flex a in terms of safety dates out 30 cents popping up on the combination of these two struck since in particular.

Shirey Dzivanovic: All right, thank you very much.

Operator: Thank you.

Unknown Executive: Our next question is from the line of Sandra Collingwood from KBC. Yes, hi, thanks for the update. I still have one small question left. It's more around clarification with regard to the Kuzantzismap follow-up trial. So, what I understand is that you will do a triple combination. But I want to understand, will you be able to generate some data on the double combination of Kuzantz and Itoclax in terms of safety data, adverse events popping up on the combination of these two medicines in particular?

You're right some of that up to two studies going on right. I mean, one is cues of in phonetic lacks the couple of told the doublet as people call. It.

Tim Van Hauwermeiren: You're right, Sandra. There are two studies going on, right? I mean, one is cusa with venetoclax, the couplet or the doublet, as people call it, and then we have the triplet. These two studies are running in parallel. We will actually be able to pick up any differences between the two treatment regimens if they would exist.

And then we have the triplets. So these two studies are running in parallel so we will actually be able to pick up any differences between the two treatment regimens if they would exist.

Sandra Cauwenberghs: Okay, thanks.

Okay. Thanks.

Tim Van Hauwermeiren: Thank you.

Thank you.

Thank you and that includes all the conference for today all disconnect. Thank you Albert participating.

Operator: Thank you. That concludes our conference for today. You may all disconnect. Thank you all for participating.

Tim Van Hauwermeiren: You write somewhere there are two studies going on right now. I mean, one is the cues are with venetoclax, the couplets or the doublet, as people call them. And then we have the triplets. So these two studies are running in parallel. So we will actually be able to pick up any differences between the two treatment regimens if they exist.

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Unknown Executive: Okay, thanks.

Operator: Thank you.

Operator: Thank you. And that concludes our conference for today. You may all disconnect.

Operator: Thank you all. , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,.. , , , , , , , , , , , Transcribed by ESO. Translated by —.

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Half Year 2020 argenx SE Earnings Call

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