Q1 2020 Earnings Call

Welcome to the genetic quoted Twentytwenty financial results.

Operator: Welcome to the ArgenX First Quarter 2020 Financial Results and Business Updates Conference This time, all participants are in a listen-only mode. To follow the presentation, we ask that you navigate the slides as directed by the presenter. There will be a question and answer session to follow. I would now like to introduce Beth DelGiacco, Vice President of Investor Relations at ArgenX. Thank you.

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Do you follow the presentation, we ask that you.

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I would now like to introduce that they've got cool Vice President Investor Relations.

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Thank you a press release with our first quarter 2020 business update and financial results was issued earlier today can be found on our website along with the presentation for today's webcast.

Beth DelGiacco: A press release with our first quarter 2020 business update and financial results was issued earlier today and can be found on our website along with the presentation for today's webcast. I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer, Keith Woods, Chief Operating Officer, and Erica Stalde, Chief Financial Officer. 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. However, actual results may differ materially from those indicated by these statements.

I'm joined on the call today by Tim Howard <unk>, Chief Executive Officer, Keith Woods, Chief operating Officer, and Eric installed <unk> Chief Financial Officer.

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 genex's 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: 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 will now turn the call over to Tim. Thank you, Beth, and welcome, everyone. I first want to wish you and your families well during a time when COVID-19 has affected all of our lives in a myriad of ways. Slide three.

I'll now turn the call over to Tim.

Thank you Beth and welcome everyone.

Our first want to wish you on your family's role during a time when covert 19 has affected.

All of our lives in immediate of ways.

Slide three.

Units, our genomics, we are committed to protecting and supporting our own please and the communities, where we live and work.

Tim Van Hauwermeiren: Here at ArgenX, we are committed to protecting and supporting our employees and the communities where we live and work. We have had a work-from-home mandate in place since March, except for certain essential roles like those in our labs. We continue to have all work-related global and domestic travel suspended.

We have had to work for more mundane in place since March.

Except for certain essential rules like Dalton overlaps.

We continue to have all work related to global and domestic travel suspended.

Even with this travel restrictions we have continued to stay close to all of our stakeholders through virtual conferences and meetings, including the investment community physicians patients patient advocacy organizations and peer groups.

Tim Van Hauwermeiren: Even with this travel restriction, we have continued to stay close to all of our stakeholders through virtual conferences and meetings, including the investment community, physicians, patients, Patient Advocacy Organizations, and Peer Groups. We have also continued to work closely together as one team, despite being in different locations. I'm very proud of the important progress we've been able to make across the company since the start of the year. This is, in large part, due to the investment we've made in IT infrastructure to accommodate our global expansion across three continents, but also due to the hard work, dedication, and flexibility of our teams. Allowing for a seamless transition to conducting business virtually.

We also continued to work closely together as one team despite being in different locations.

I'm very proud of the important progress we've been able to make across the company since the start of the.

This is in large part due to the investments we've made an IP infrastructure to accommodate our global expansion over pretty confidence.

But also due to the hard work dedication and flexibility of our teams.

Allowing for a seamless transition to conducting business virtually.

Even during a time when a lot is uncertain.

Tim Van Hauwermeiren: Even during a time when a lot is uncertain, we are confident in the strong fundamentals of our business, including a differentiated antibody pipeline and a solid financial position that allows us to advance our growth and development strategy and ultimately deliver meaningful immunology innovations to patients who need them. Moving on to the topics of our call, slide four, we have a focused agenda today. The primary goal of the call is to provide you with an overview of the impact of COVID-19 across our business and detail what we're doing to mitigate the situation. We will also update you on the development of argenx-117, our complement inhibitors targeting C2. We have delayed the start of our phase one trial in healthy volunteers but, in the meantime, we have had the opportunity with one of our immunology innovation program collaborators to launch a first in human trial of argenx117 in COVID-19 patients. There is a growing understanding of the role of complement systems in driving severe respiratory symptoms associated with the virus.

Our confidence in the strong fundamentals of our business.

Including a differentiated antibody pipeline and is solid financial position.

That allows us to advance our growth and development strategy.

And ultimately deliver meaningful immunology innovations to patients who need to.

Moving onto the topics of our call slide four we had a focus that the agenda for today.

The primary goal to call is to provide you with an overview of the impact of Corbett 19 across our business and detail what we're doing to mitigate the situation.

We will also update you on the development of our Gen X 117, our complement inhibitors targeting see too.

We have delayed the start of our phase one trial in healthy volunteers, but in the meantime has had the opportunity with one of our immunology innovation program collaborators to launch a first in human trial of our Jennings from 17 covert 19 patients.

There's a growing understanding of the role of complement system in driving severe respiratory symptoms associated with the virus.

Tim Van Hauwermeiren: We feel we are upholding our social contract to help tackle this global health crisis while also gaining critical information about ArgenX 117 during a time when it is difficult to enroll trials in healthy volunteers. We also want to use this call to talk about the updated data presented this week on Afgha Tijamat in our third beachhead indication, Pemphigus. Professor Matthias Goebbler presented detailed Phase II data at the Society for Investigative Dermatology annual meeting that is being held virtually. The data show the promising tolerability profile and speed at which Avogadro-Tikkimor can push patients into disease control and complete remission when combined with suboptimal doses of prednisone. Legend of Khalf, Keith is going to cover our ongoing preparations for our planned 2021 U.S. commercial launch. The last few months have encouraged us to look at our launch preparations with a new lens, and we are scenario planning around the unknown and potentially longer-term effects of coronavirus infection. Eric will then walk through our financial results for the quarter.

Few be upholding our social contract to help cycle. This global health crisis, while also gaining critical information about our generics on 17.

During a time when it is difficult to enroll trials in healthy volunteers.

We also plan to use this call to talk about the updated data presented this week and I've got to Jim off in Alberta, beachhead indication and tickets.

Professor Mafias good luck.

Presented the detailed phase two data at the society for investigative dermatology annual meeting that is being held virtually.

The data showed a promising tolerability profile and speed at which I've got taken most can push patients into disease control and complete remission when combined with sub optimal doses of Britain is on.

Let's turn the call.

This is going to cover our ongoing preparations for up for our plants Twentytwenty, you've known us commercial launch of Ekati come up in generalized my Stena greatness.

The last few months have encouraged us to look at our launch preparations within new Len.

Envious scenario planning around the unknown and potentially longer term effects have grown up buyers infection.

Yes. It will then walk through our financial results for the quarter.

Tim Van Hauwermeiren: With that, I'd like to update you on our ongoing program. We have not passed any of our ongoing clinical trials and are diligently monitoring that our patients and physicians are taking appropriate measures to stay safe while participating in the studies, to enable patients in Argenx clinical trials to receive study drugs with continuity. We have implemented telehealth and remote monitoring activities and more flexible dosing schedules into protocols where possible. On slide five,

With that I'd like to update you on our ongoing programs.

We have not passed any of our ongoing clinical trials and are diligently monitoring that our patients and physicians are taking appropriate measures to stay safe what participating in the studies.

To enable patients in our genomics clinical trials to receive study drug could continuity.

We have implemented tele health and remote monitoring activities and the more flexible dosing schedules into protocols where possible.

On slide five for that.

Tim Van Hauwermeiren: Our phase 3 trial of F-gut-tig and modern GMG, that study remains on track; I must pay tribute here to the hard work from our MG team. We enrolled this trial faster than anticipated, which turned out to be an incredibly important milestone, particularly in view of the current situation. By the time the shelter-in-place restrictions went into effect, All 167 patients in ADAPT had already passed the eight-week time point for the analysis of the primary endpoint, and the majority of patients had already rolled over into the open-label extension. As an update today, all patients have now completed the 26-week primary trial. We will be reporting top-line data mid this year, which sets us up to file a BLA before the end Additionally, we are on track to fight in Japan in 2021.

Our phase three trials have got taken more than gmg.

Lets study remains on track I must pay tribute to the hard work from Robert EMG team.

We enrolled this trial faster than anticipated, which turned out to be an incredibly important milestone, particularly in view of the current situation.

By the time to shelter in place distinctions went into effect all hundred 67 patients in it that has already passed the each week time points for the analysis of the primary endpoint and the majority of patients had already rolled over into the open label extension.

As an update today all patients has now completed the 26 week private trial.

We will be reporting topline data mid this year, which sets us up to Farleigh BLE before the end of Twentytwenty assuming success.

And to launch in Twentytwenty wrong in the United States.

Additionally, we are on track to fight in Japan in Twentytwenty wrong.

We were very pleased with a high degree of rollover to the open label extension study, which remains firmly on track.

Tim Van Hauwermeiren: We were very pleased with the high degree of rollover to the Open Label Extension study, which remains firmly on track. We are working closely with our CRO and trial sites to facilitate patients staying on study. We are also incorporating some of the measures I mentioned above, including remote monitoring and home infusion. Fortunately, the MG ADL assessment is one that can be accommodated remotely. The primary goal of the OLE is to gather the necessary safety data for our BLA filing, and we remain confident this will happen. Supply chain and manufacturing remain a crucial component of our clinical development and commercial launch planning. We partner with Lonza and Vetters, who have shown their strength through this crisis.

We are working closely with our COO and trial sites to facilitate patients staying on study.

We are also incorporating some of the measures I mentioned, the buff, including remote monitoring and home infusions.

Fortunately the Mg LDL assessments is one of the can be a common data to remotely.

The primary goal of the orally.

To gather the necessary safety data for I would it be late filing and we remain confident this will happen.

Supply chain and manufacturing with me a crucial components of our clinical development and commercial launch planning.

We are proud with Lonza investors, who have shown that strength through this crisis.

Tim Van Hauwermeiren: Our global supply chain of drug substance and drug product remains unaffected and on track to support the launch in 2021. Our pipeline overview slide is on slide 6. Our trials of FGAP-Tikamots that have already initiated remain open, including the Phase 3 advanced trial evaluating IV FGAP-Tikamots in primary ITP, the phase 2 Adhere Trial Evaluating Sub-Q F-graftigamot in CIDP Patients, and the 11 patients still on study in the phase 2 trial evaluating IV at Gartigmont in Pemphigus.

Our global supply chain of drug substance and drug product remains unaffected and on track to support the launch in Twentytwenty wrong.

Our pipeline Overages slide on slide six.

Our trials with uptick in wells that have already initiated remain open.

Including the phase advanced trial evaluating Ivy of Kartik him ups in primary RTP.

The phase two trial evaluating Subcu F. Cup, taking them out in CDP patients and the 11 patients still on study into phase two trial evaluating Ivy I've got to come up in pet figures.

We do expect recruitment rates for the IP and CDP trials to be slowed due to covert 19.

Tim Van Hauwermeiren: We do expect recruitment rates for the ITP and CRDP trials to be slowed due to COVID-19. We will provide an update on any potentially revised timelines as we have greater clarity, but it's currently too early to estimate the real effect. We are fortunate in that we run global trials in North America, Europe, and Japan, so we are not confined to one affected area for patient recruitment. We will use this to our advantage as best as we can in opening new sites.

We will provide an update on any potentially revised timelines as we have greater clarity, but it's currently too early to estimate the real effect.

We are fortunate in that we're going to global trials in North America, Europe, and Japan. So we have not confined to bottom perfected area for patient recruitment.

We will use this to our advantage as best as we can in opening new sites.

Importantly, we do not currently foresee a delayed through the launch of new I've got taken more trials and our guidance remains intact.

Tim Van Hauwermeiren: Importantly, we do not currently foresee a delay in the launch of new IVGAR-Tigma trials, and our guidance remains intact. Two additional ITP Phase 3 trials are on track to start before the end of the year, which we expect, along with advance, will support registration for ergartigamot in primary ITP, assuming positive data. These trials include the ADVANCE II confirmatory trial evaluating IV Fgartigamot in approximately 50 primary ITP patients that is expected to start in the first half of 2020, and the ADVANCE Sub-Q trial, evaluating both IV and Sub-Q maintenance of gartigumab that is expected to start in the second half of 2020. The PV registration trial is on track to start by the end of the year.

Two additional IP phase two trials are on track to stop before the end of the year.

Which we expect along with advance will support registration for I've got to take them up in primary IP assuming positive data.

These trials includes the advance to confirmatory trial evaluating Ivy I've got to come out in approximately 50 primary IP patients that is expected to start into first half of Twentytwenty.

And the advance Subcu trial evaluating both Ivy and Subcu maintenance I've got picking them up that is expected to start in the second half of Twentytwenty.

The PV Registrational trial is on track to start by end of year.

Tim Van Hauwermeiren: Our decision to move to Phase 3 was based on the strength of the data we saw in Phase 2, which I will walk through shortly. And finally, for Avgar Tikamov, we do still plan to announce our fifth indication this year. Before moving on, I'd like to quickly touch on how our partners have handled ongoing clinical trials, slide 7. Jensen has passed many trials globally due to COVID-19. At this time, both trials are coming to a close, and the triple combination trial of Cusatuzumab, Venetoclax, and Azacitidine is both passed for enrollment. Additionally, Janssen has paused the launch of new studies of gizotuzumab. Leupharma has passed this trial of LP0145 for the treatment of atopic dermatitis. This is the compound that was previously known as Argenx 112. We cannot say today when or under what circumstances.

Our decision to move to face Cmos based on the strength of the data we saw in phase II, which I will walk through shortly.

And finally for upcoming pick them up we do still plan to announce our 50 indication this year.

Before moving on now I'd like to quickly touch on how our partners have handled ongoing clinical trials slide seven.

Janssen has passed many trials globally due to cope 19.

At this time, both culminates and the Triple combination trial excuse us Doosan, Matt Veneto, Clecs and is a site the dean or both Pos for enrollment.

Additionally, Janssen has passed the launch of new studies of Jews Autousa map.

Leo Pharma Hispasat. This trial of LPG 0145 for the treatment of topic dermatitis. This into compounds that was previously known as our Jennings from 12.

We cannot say today, when or under what circumstances DQ, so to sum up trials or dose in the hands of Leo will be up and running again.

Tim Van Hauwermeiren: The Cues of Tuzla trials, or those in the hands of Leo, will be up and running again. We will be sure to update our stakeholders once we know more. Enrolment remains open in the ADVIS Phase 1 trial of ABBV151, which was previously ArgenX 115. Now on to ArgenX 1.17. You will note that we did not start the phase 1 trial in healthy volunteers in the first quarter. We felt it was not prudent to initiate this trial in the current environment given the challenges with recruiting healthy volunteers.

We will be sure to update our stakeholders once we know more.

Enrollment remains open in at least phase one trial of ADB, one five wall, which was previously our genomics on 15.

Now onto our genomics on 17.

You will note that we did not stop a phase one trial in healthy volunteers into first quarter.

We felt it was not prudent to initiate this trial in the current environment given challenge us with recruiting healthy volunteers.

We did start to phase one dose escalation trial in corporate 19 patients as I mentioned at the stop if I recall and I'd like to walk you through to brief rationale for this shown on slide eight.

Tim Van Hauwermeiren: We did start a phase one dose escalation trial in COVID-19 patients, as I mentioned at the start of our call, and I'd like to walk you through the brief rationale for this, as shown on slide eight. It has been a difficult few months to watch tragedy strike the healthcare and broader community, when Professor Bart Lombrecht, our collaborator from VIP Ghent University Hospital, and the Belgian National Commissioner for the Pandemic approached us about sponsoring a trial. We felt it was important and our duty to participate. Second, we always base our development decisions on a strong biological rationale, and that is one with ArgenX117 targeting C2. The role of the complement system is known in the activation of an inflammatory response that can lead to acute respiratory distress syndrome in coronavirus infections.

First.

It has been difficult.

Difficult few months to watch tragedy strike, the healthcare and broader communities.

When professor Barnes lung breast.

Collaborator from VIP against University Hospital, and the Belgium National Commissioner for the pandemic approached us about sponsoring a trial, we felt it was important and opportunity to participate.

Second.

We always base our development decisions on a strong biologic rationale and that is one with our Jennings from 17 targeting see too.

The role of complement system is known in the activation often inflammatory response that can lead to acute respiratory distress syndrome in quarter, one off items infections.

C sits at the junction of the classical and lectin pathway, which are both implicated in the downstream inflammatory response.

Tim Van Hauwermeiren: He too sits at the junction of the classical and lectin pathways, which are both implicated in the downstream inflammatory response. We will first conduct a dose escalation study in patients in recovery from the coronavirus and then shift to dosing patients at risk of developing ARDS. Through this first-in-human trial, we will also gain important data points about argenix-117, including PK, PD, Safety, and Tolerability, and possibly an optimal go-forward dose, all of which can be part of our broader development strategy. We still intend to launch a Phase 1 trial of ArgenX 117 in healthy volunteers before the end of 2020. We can then move forward with our Phase II strategy in severe autoimmune disease, including our first planned indication, multifocal motor neuropathy. Moving on to other news items.

We will first conduct a dose escalation study in patients in recovery from the quarter Novartis, and then shift to dosing patients at risk of developing yes.

Through this first in human trial, we will also gained important data points about our Jennings from 17.

Including PK, PD safety, and Tolerability and possibly an optimal go forward dose all of which can be part of our broader development strategy.

We still intend to launch phase one trial of our Gen excellent 17 in healthy volunteers before the end of Twentytwenty.

We then can move forward with our phase two strategy in severe auto immune disease, including our first planned indication multi focal Martin neuropathy.

Moving onto other news.

Tim Van Hauwermeiren: As you saw in the press release from this morning, detailed data were presented this week from the Adaptive Phase II trial of FGATIGIMOD in Pamphigus at the SID annual meeting. The meeting changed to be virtual, and our pre-recorded oral presentation became available online yesterday. We are grateful to Professor Goebbels from the University Hospital of Wurzburg for his flexibility in presenting the data in this less traditional format. Slide nine

As you saw in the press release from this morning detailed data were presented this week from the adaptive phase two trial of I've got Digimarc intensive goods at DS I'd annual meeting.

The meeting change to be virtual and our pre recorded oral presentation became available online yesterday.

We are grateful to professor Gerba.

From University hospital of risk.

For this flexibility in presenting the data in this less traditional format.

Slide nine.

Tim Van Hauwermeiren: Recall, in designing this trial, we took a unique and adaptive approach to evaluate the potential of F-graftage, a modern panthagus, while adjusting in a single variable way the dose between 10 and 25 mg per kg. The Dosing Schedule and The Dosing Paradigm between Monotherapy and Combination Therapy with Corticosteroids. We also assess the ability to taper steroids once patients reach the end of consolidation. The updated data shown this week are from a data cut-off of March 25, 2020 and included the below highlights that are also shown on slide 10. 90% or 28 of 31 patients evaluable for efficacy achieved rapid disease control. The median time to disease control for monotherapy and combination therapy was 15 and 20 days, respectively. The majority of patients reached disease control after one or two infusions. Complete clinical remission was observed in 70%, or 7 of the 10 patients receiving an optimized dosing regimen, determined to be Epgar-Tigemod administered at least every 2 weeks, in combination with oral prednisone at a dose of 0.25 to 0.5 mg per case.

Recall in designing this trial, we took a unique and adaptive approach to evaluate the potential affected your model batsakis, while adjusting in a single valuable way dose between 10, and 25 smucker kick the dosing schedule and the dosing paradigm between model.

At upbeat and combination therapy with corticosteroids.

We also assessed the ability to taper steroids once patients reached end of consolidation.

The updated data showing this week our from a data cut off of March 25, 2020 and included the below highlights that are also shown on slide 10.

90% or 28 of 31 patients evaluable for efficacy achieved rapid disease control.

The median time to disease control for monotherapy and combination therapy was 15 and 20 days respectively.

The majority of patients, which disease control after one or two infusions.

Complete clinical remission was observed in 70% or seven of the 10 patients receiving an optimized dosing regimen determined to be picking them up those at least every two weeks in combination with oral prednisone at the doors of point 25, 2.5 make the cake.

73% or 11 of the 15 patients receiving 25 million kick up kartik them up achieved end of consolidation, including patients who done successfully tapered tested or doors.

Tim Van Hauwermeiren: 73%, or 11 of the 15 patients receiving 25 mg per kg of gartigumab achieved end of consolidation, including patients who then successfully tapered their steroid dose, and 11 patients are currently still on study. We had an independent data monitoring committee that assessed the safety and tolerability profile of Edgar Tiggemart, and they felt it was favorable. This is very consistent with what we have seen across all our EFGATICAMO trials. Patients enrolled in the last cohort of the PAMFGS trial will be receiving Efgartigamot for up to 34 weeks, which is the longest treatment period to date, excluding open-label extension studies. Taking this data together, we are confident that we have shown important proof of concept in our third beachhead indication and have gathered the necessary information to design a robust registration trial in PV.

And 11 patients are currently still on study.

We had an independent data monitoring committee that assist the safety and Tolerability profile of adopting them up and they felt it was favorable.

This is very consistent with what we have seen across all our have got to human trials.

Patients enrolled in the last quarter defense against trial will be receiving Africa take them up for up to 34 weeks, which is the longest treatment period to date, excluding open label extension studies.

Taking these data together.

We are confident that we have shown important proof of concept in our third beachhead indication and have cabinets the necessary information to design a robust registration trial NPV.

With that overview I'll now turn the call over to key.

Keith Woods: With that overview, I'll now turn the call over to Keith for a discussion of our commercial webinar. Thank you, Tim, and good morning, everyone. As Tim noted, we are very excited to be nearing the top-line data readout from our Phase 3 ADAPT study in GMG patients. This is a transformational moment for the company and will mark a shift toward our goal of being an integrated immunology company. We built an innovative trial design for our Phase 3 ADAPT trial that we believe closely mirrors how physicians would use FGAR-TigaMOD in practice. As we scale up our commercial team in Boston and throughout the U.S., these data will provide us with unique insights into patient management and how Efgartigamad could integrate into the current M.G. treatment paradigm. As you look at slide 11. Right now, if you look at the current M.G.

For a discussion of our commercial readiness.

Thank you, Tim and good morning, everyone.

As Tim noted, we're very excited to be nearing the topline data readout from our phase three adapt study EMG patients.

This is a transformational moment for the company and we'll market shifts towards our goal of being an integrated immunology company.

We built an innovative trial design for our phase three adapt trial that we believe closely mirrors, how physicians would use after our ticket Ahmad in practice.

As we scale up our commercial team in Boston and throughout the US. These data will provide us with the unique insights into patient management and how effort ticket to integrate into the current EMG treatment paradigm.

As you look on slide 11.

Right now if you look at the current EMG treatment landscape. We believe we can play across the spectrum of patients.

Keith Woods: In the treatment landscape, we believe we can play across the spectrum of patients, from earlier in the treatment cycle to the more severe refractory patient. MG first presents with ocular symptoms, and patients receive acetylcholine esterase inhibitors, or ACIs, at diagnosis. As symptoms become more generalized, physicians will move to steroids. But in order to taper steroids and reduce the significant side effect burden experienced by patients, physicians will use broad-spectrum immunosuppressants, which can take time to kick in and come with their own set of side effects and risks.

Earlier in the treatment cycle to the more severe refractory patients.

EMG.

First presents with ocular symptoms and patients receive.

I still coleen estrace inhibitors or.

At diagnosis.

As symptoms become more generalized physicians will move to steroids, but in order to taper steroids and reduce the significant side effects burden experienced by the patients physicians will use broad spectrum immunosuppressants.

Which can take time to kick in and come with their own set of side effects and risks.

Keith Woods: Agents like IVIG, Rituximab, and Teleris are used later in the progression of the disease when earlier agents are no longer effective. Our goal for FGAR-Tigamod is to allow for earlier steroid tapering and to delay or even eliminate the need for broad immunosuppressants. Moving to slide 12.

Agents like IBG, Rituximab and Solaris our years later in the progression of disease. When earlier agents are no longer effective.

Our goal for F. Guar Ticketmaster is to allow for earlier steroid tapering and to delay or even eliminate the need for broad immunosuppressants.

Moving to slide 12.

Keith Woods: If we take this positioning and look at the addressable market, we believe we can target about 30% of GMG patients in the U.S., or about 20,000 patients based on a U.S. M.G. patient population of 65,000. This would be all generalized MG patients who require treatment beyond steroids and ACI. To reach these patients and the 16,000 neurologists who treat them, we will start to build a sales force of approximately 70 representatives, assuming positive data scenarios. We've already built a network of medical research liaisons who have been engaging with neurologists across the country for the past 18 months, and we have more recently built our Thought Leader Liaison Network. Moving to Japan.

If we take this positioning and look at the addressable market. We believe we can target about 30% of DMD patients in the us or about 20000 patients based on a U.S. EMG patient population of 65000 in the U.S.

This would be all generalized DMD patients who require treatment beyond steroids and AC eyes.

To reach these patients and the 16000 neurologists, who treat them, we will start to build a salesforce of approximately 70 representatives assuming positive data scenario.

We've already built a network of medical research liaisons, who have been engaging with neurologists across the country for the past 18 months.

More recently built our thought leader liaison network.

Moving to Japan.

Keith Woods: We believe there are about 20,000 patients that suffer from MG being treated by two to three hundred neurologists in Japan. The concentrated nature of the MG market and the universal health care coverage make Japan a very appealing market for our second launch. The COVID-19 pandemic has not slowed our commercial readiness progress, but it has made us stop and consider the environment into which we could be launching our drug next year. Our team is committed to preparing for all scenarios, including a world that generally returns to normal where we can activate our sales force to be present in doctor's offices and hospitals, and a world that is in full shutdown after another outbreak where we have to launch through virtual and digital interactions only. And somewhere in between, where we believe we have to embrace a new normal and rely more heavily on digital and virtual capabilities while still having the option to see customers in person.

We believe there about 20000 patients that suffer from EMG being treated with two by two to 300, neurologists and Japan, the concentrated nature of the EMG market and the Universal healthcare coverage make Japan, a very appealing market for our second launch.

The cobot 19 pandemic has not slowed our commercial readiness progress, but it has made us stop and consider the environment into which we could be launching our drug into next year.

Our team is committed to preparing for all scenarios, including a world that generally returns to normal where we can activate our salesforce to be present in doctors' offices and hospitals.

Or a world that is in full shutdown after another outbreak, where we have to launch through virtual and digital interactions only.

And somewhere in between where we believe we have to embrace a new normal and rely more heavily on digital advertorial capabilities, while still having the option to see customers in person.

Keith Woods: We will be ready for any of these scenarios and have organized work streams across all key launch functions to consider the implications of this new norm. To wrap up, and to reiterate Tim's earlier comments, our global supply chain remains on track for launch. We are grateful to be working with Lanza and Vetter on our global manufacturing and have witnessed the capabilities of both organizations to activate risk mitigation strategies where necessary.

We will be ready for any of these scenarios and have organized work streams across all key launch functions to consider the implications of this new normal.

To wrap up and to reiterate Tim's earlier comments, our global supply chain remains on track for launch we are grateful to be working with Lonza and better for our global manufacturing and have witnessed the capabilities of both organizations to activate risk mitigation strategies where necessary.

Erica Stalde: We also continue to prioritize the development of our subcutaneous F-Guardigmod product in MG to provide optionality for patients, physicians, and payers. We are planning to meet with the FDA this year on a potential bridging strategy and will communicate once we have a clear path forward. With that, I'd like to turn the call over to Eric for a review of our financial results. Thanks, guys. Slide 13 covers our first quarter 2020 operating results, which are detailed in today's press release and regulatory file. As you can see on this slide, total operating income reached 23.4 million euros for the first three months of 2020. Decreased from the same period in 2019 due to a milestone payment we received last year under the AbbE collaboration. R&D expenses for the three months ended March 31st 2020 were 94.9 million euros, compared to 34.8 million euros for the same period in 2019. SG&A expenses were 25 million euros for the first three months of 2020 compared to 11.3 million euros for the same period in 2009.

We also continue to prioritize the development of our subcutaneous F. garden products EMG to provide optionality for patients physicians and payers.

We are planning to meet with the FDA. This year on a potential bridging strategy and we'll communicate once we have a clear path forward.

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

Thanks Keith.

Slide 16, Colleville's I'll first quarter Twentytwenty operating results, which are detailed in today's press release on I think you'd have to lease signings.

So as you can see only slight took volatility income reached 23.4 million euros fall to assist treatments of twentytwenty.

A decrease from the same period in 2019 to license.

Payments, we received last year on building a de collaboration agreements.

R&D expenses for the three months on much selfishness, twentytwenty, well 94.9 million euros.

Compared to 64.8 million euros for the same period in 29.

As Ginny expenses with 25 million euros for the first three months of twinkie compared to 11.3 million euros for the same period in 2000.

The increase in R&D and as Ginny expenditure, although the prior year I've been driven by the progress made.

Erica Stalde: The increases in R&D and SG&A expenditures over the prior year have been driven by the progress made with our late-stage pipeline, including higher consulting and personnel expenses, higher clinical trial costs, and manufacturing expenses, and 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. For the first three months of 2020, financial income amounted to 1.7 million euros compared to 3.5 million euros for the same period in 2019. Exchange gains totaled 20.8 million euros for the three months ended March 31st 2020 compared to 9.5 million euros for the same period in 2000. The total net loss for the three months ended March 31st, 2020, was 80 million euros, compared to a total comprehensive profit of 6.7 million euros for the same period last year.

Stage pipeline, including higher consulting until somebody expenses higher clinical trial cost on manufacturing expenses and development of additional employees to support ongoing activities.

We expect operating expenses to continue to increase this year as we saw the advance pipeline.

Future commercialization.

For the first three months of 2025.

Financial income amounted to 1.7 million euros compared to 3.5 billion euros for the same period 2000 miles.

Exchange gains totaled 20.8 million euros for three months.

Last Dusty feels twentytwenty compared to 9.5 million euros fill the same period in 2009.

The total net loss for the three months and each must still feels twentytwenty was 80 million euros.

To a total comprehensive proceeds of 6.7 million euros for the same period last year.

You will recall this profits was an outlier again to the milestone payment we received last year from.

Erica Stalde: You will recall this profit was an outlier due again to the milestone payment we received last year from AVI as mentioned previously. So we ended the first quarter of 2020 with 1.3 billion euros in cash, cash equivalents, and current financial assets, compared to 961.6 million euros for the same period in 2009. And I will now turn back the call to... Thank you, Eric, slide 14. 2020 is off to a strong start, and we expect to have an especially exciting year as we need to readout top-line data from our ADAPT trial and advance EFGAR TIGERMOD toward commercialization. We continue to have strong fundamentals across our business, including our pipeline of late-stage product candidates with EPCRA TigaMod being evaluated in four indications and Qsatusumab in EML and high-risk MDS, as well as our growing pipeline of early stage candidates with ArgenX 1.17, ArgenX 1.18, and ArgenX 1.19 this year.

As mentioned previously.

So we ended the first quarter of Twentytwenty with 1.3 billion euros in cash cash equivalents current financial assets compared to 961.6 million euros for the same period in 2000 miles.

And then we'll now turn back to the call touching.

Thank you Eric Slide 14.

20 trend is off to a strong stuff and we expect to have a especially exciting year as we need a topline data readouts from our that trial and advance I've got picked them up toward commercialization.

We continue to have strong fundamentals across our business, including our pipeline of late stage product candidates with thinking about being evaluated in four indications and use of to sum up and ml and high risk Mds as well as our growing pipeline of early stage candidates with Agenuss onset.

And team not any swung 18, and Thats Index fund like in this year.

We continue to expect up to 550 trials and seven earlier stage clinical trials to be ongoing this year indications that are synergistic to our growing commercial infrastructure.

Erica Stalde: We continue to expect up to five VC trials and seven earlier stage clinical trials to be ongoing this year in indications that are synergistic to our growing commercial infrastructure. We are very enthusiastic about the prospects for F.G.T. in NG and are preparing for success by growing our commercial team. And, as Eric mentioned, we are grateful to have a strong cash position during this time of uncertainty, thanks to the ongoing support of our shareholder partners. Before turning the call over to your question...

We are very antiseptic about the prospects for accepting them up in LNG.

And are preparing for success by growing our commercial team.

And as Eric mentioned, we are grateful to have a strong cash position. During this time of uncertainty thanks to the ongoing support of our shareholders.

Before turning the call over to your questions I would really like to take the time to acknowledge and applause dose on the frontline fighting this global pandemic.

Tim Van Hauwermeiren: I would really like to take the time to acknowledge and applaud those on the front line fighting this global pandemic. In particular, those nurses and physicians providing direct care for COVID-19 patients, including some of our own employees who have devoted their own time to this cause. With that, I will now turn the call over to the operator for your questions. Ladies and gentlemen, we will now begin the question and answer session.

In particular.

Those nurses and physicians, providing direct and for corporate 19 patients.

Including some of our own employees, who have the afforded that old time to this course.

With that I will now turn the call over to the operator for your questions.

Thank you.

We will now begin to question and answer session.

Operator: As a reminder, if you wish to ask a question, please press star and 1 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A. If you wish to cancel your request, please press the hash- We also request that you limit your questions to make sure everyone has a chance to ask their questions. We will now be taking our first question from the line of Ted Tentosk. Piper Sanders, please go ahead; your line is now open.

Yes.

Good question. Please press Star one Tennessee.

Tibia now.

Please standby coupled with the Q.

Yes, let me take a few moments.

If you will.

Your request. Please go ahead.

We also request that you limit. Your question can you can make sure everyone has its John.

Yes.

We will now be taking questions from the line as Ted Tenthoff from Piper Jaffray. Please go ahead. Your line is now open.

Tim Van Hauwermeiren: Excellent. Thank you so much. And a great update. Glad to hear everyone's doing well. Just with respect to the upcoming Myasthenia gravis study, Keith, I appreciate all the commentary on potential for build-out. How quickly would you guys be able to file the BLA? And what would your plans be for Europe?

Thank you so much and great update glad to hear everyone's doing well.

Just with respect to the upcoming.

But for the Gravis study Keith I appreciate all the commentary or.

Until four build out.

How quickly.

You guys be able to file that be law.

And what would be your plans for Europe. Thank you so much.

Tim Van Hauwermeiren: Thank you so much. Thank you, Ted. And good to hear your voice. Good to hear that apparently everything is fine. And so with the phase three data readouts planned for mid 2020, what we say, Ted, is that we are on track to file the BLA by the end of the year. That basically puts us in position for a launch in 2021.

Yes.

Thank you Ted and good to hear the voice cut to hit that apparently everything is fine.

So with that phase two data Readouts planned for mid 2020 would be say Ted is that we're on track to file the delay by the end of the year that basically puts us in position for launch in Twentytwenty warm.

Tim Van Hauwermeiren: How long exactly the review procedure with the FDA will take, we do not know. But I would like to call out our earlier announcement that actually we did receive a fast track by the FDA. Yep, congratulations on that. And then what are the plans for Europe?

How long executive review procedures with the equity able take we do not know, but I would like to call out our earlier announcement that actually we did receive a fast track.

By the FDA.

Yes, congratulations on that and then what would be plans for Europe is that something you would consider taking on this helps I appreciate the commentary on Japan.

Tim Van Hauwermeiren: Is that something you would consider taking on yourself? I appreciate the commentary on Japan, but would Europe be a potential partnering opportunity?

But would European potential partnering opportunity or would you expect to launch their yourselves as well thanks Alex.

Tim Van Hauwermeiren: Or would you expect to launch it there yourselves as well? Thanks so much. Now, what we said in our public chat is that priority number one is going to be the US, priority number two will be Japan, and then we have declared our intention to be active in Europe as a third priority, where we called out the big five as the countries where we may become active, but that is our third priority. Excellent. Thanks so much, Tim. Be well. Thank you, Pat. We will now be taking our next question from the line of Christopher. Is that right?

Now let me set in public tender that number one is going to be the U.S. players and number two will be Japan, and then we have declared our intention to be active in Europe as a third priority, where we called out the big five.

As the countries, where we may become active but that is our third priority.

Excellent. Thanks, so much can be well.

Thank you Pat.

We will now be taking our next question from the line as Christa.

Please.

Keith Woods: From Nomura, please go ahead; your line is now... Good morning. Thank you for taking the question. You know, I was wondering, you know, first, maybe for Keith, if you could describe your plans for the launch, you know, with respect to potentially launching this drug in a virtual mode, and then secondarily, you know, how ready you are for initiation of home infusions? You know, how experienced, I have a follow-up question, how much experience do the KOL's have with that right now, and how much do And I have a follow-up question. Yeah, Chris, thank you for the question.

Please go ahead. Your line is now open.

Good morning, Thank you for taking the questions.

I was I was wondering first maybe for key if you could describe.

Your plans for the launch.

With respect to potentially.

Launching this drug in a virtual mode, and then secondarily how how.

Ready you are or initiation of home infusions.

Hum experience, which experienced due to the K wells have with that right now.

And how much do you expect dogs to be able to adopt hill infusions at the early part of.

The launch and I've a follow up thank you.

Yes, Chris. Thank you for the question so as I mentioned in the prepared statements were preparing for all scenarios across our launch work streams.

Keith Woods: So, as I mentioned in the prepared statements, we're preparing for all scenarios across our launch work streams. You know, obviously, it's much more difficult to launch when you can't schedule in-person interactions with physicians and patients and payer groups. However, we are managing to work with all three of those groups, even in this current situation. We're not alone in this scenario.

Obviously this it's much more difficult to launch when you can't schedule in person interactions with the physicians and patients in the air group's however, we are managing to work with all three of those groups even in this.

In this current situation.

We're not alone in this scenario.

Keith Woods: As you know, every other company is in this scenario. And what I can say is, maybe we're a little bit lucky that we weren't launching this year when COVID-19 hit us for the first time, and we were in full launch, because we still have time to learn to plan and to adapt. And that's basically what we're doing is looking directly to more virtual and digital approaches while, at the same time, still trying to be innovative in our approach. Okay, and then just with respect to the home infusion, how prepared are you for that, and how much experience do physicians have with your drug and home infusion? So one of the steps that we have taken in clinical trials has been to make the availability of home infusions possible for some of our sites.

As you know many other every other company as in this scenario and what I can say is maybe we're a little bit lucky that were not launching this year when cobot 19 hit us for the first time and we were in full launch because we still have time to learn to plan and to adapt.

And that's basically what we're doing it looking directly to more virtual and digital approaches while at the same time still trying to be innovative and our approach.

Okay, and then just with respect to the home infusion.

How how prepared are you sure out and how much experience do that physicians have with your drug and home infusion.

Dosing so one of the steps that we have taken in clinical trials has been to make the availability of home infusion possible for some of our sites. So we have started to convert over to that in our clinical trials.

Keith Woods: So we have started to switch over to that in our clinical trials. We already know that many GMG patients that receive IVIG will get that from a route of home infusion, so it is something that we were already exploring and speaking with the home infusion companies in preparation for launch. So I think being able to adapt to this as a location for treatment should not be a challenge for us.

We already know that many gmg patients that received Ivy League, we'll get that from a route of home infusion. So it is something that we were already exploring and speaking with the home infusion companies in preparation for launch so I think to be able to adapt to this as that location for treatment.

Should not be a challenge for us.

Okay, and then just one last one with respect to.

Keith Woods: Okay, and then just one last one with respect to, you know, potential for less frequent dosing: argenx NV, Vyvgart, ArgenX NV, Vyvargat, ArgenX NV, Vyvargat, ArgenX NV, Vyvargat, Yeah, well, I guess first of all, in regard to the dosing, I don't want to speculate, I'm looking forward to I do remind you, Chris, as you know, that in the phase two data, 75% of the patients had a response of at least six weeks. And in reality, the majority of those patients were still responding at week 11. So we'll still need to see the data. When it comes to patients being compliant with their medication when they have a customized dosing schedule, this is how many patients are currently being treated. So I would call this example chronic IVIG, whereas if you look at patients with MG that are treated with IVIG, they are not all on an identical dosing schedule.

Potential for less frequent dosing.

You know compliance type issues that could arise whether it's in a trial or otherwise obviously in mg antibodies causal to the disease, but but I was wondering if you could frame and maybe Keith can payments from from a market access perspective or market perspective compliance perspective.

You know how often you expect patients.

Just to be receiving doses and the potential for them to delay doses from what's happened sort of in the trial setting.

How are you thinking about that how or maybe some kalo thinking about that practice. Thank you.

Yes, well I guess first of all in regard to the dosing I don't want to speculate I'm looking forward to seeing the phase three data.

I do remind you Chris as you know that in the phase two data 75% of the patients had a response of at least six weeks and reality. The majority of those patients were still in response at week 11.

So will still need to see the data.

When it comes to patients being compliant with their medication when they have a customized dosing schedule. This is how many patients are currently being treated so I would call. The example to chronic fiveg, whereas if you look at patients with Mg that are treated with IBG, they're not all on an identical dosing scheme.

Joel.

Keith Woods: It's basically these MG patients can feel the beginning of the return to symptoms, and then they are going to want to get their medication. So I believe that how we set this up is going to allow patients to be customized, but at the same time, they will want to be treated because they want to live a symptom-free life. Thank you. We will now be taking questions from Tiago Volf for Credit Suisse.

Basically these EMG patients can field the beginning of the return to symptoms and then they are going to want to get their medication. So I believe that how we set this up is going to allow patients.

To be customized but at the same time, they will want to be treated because they want to live symptom free life.

Thank you.

We will now be taking our next question.

Both from Credit Suisse. Please go ahead your line is.

Hi, guys. Thanks for taking the question I had a follow up and enhance formulation and I'm curious if you generated additional orientation data.

Tim Van Hauwermeiren: Hey guys, thanks for taking the question. I had a follow-up on the enhanced formulation. I'm curious if you generated additional inpatient data to support every other week sub-Q injection. How does that stack up against the model data?

To support the every other week Subcu injection, how does that stack up against that model data and just a quick follow up on sense, because if it just recap the target population positioning for precision model relative to Rituximab and the commercial opportunity that we havent that indication. Thanks, Thanks a lot.

Tim Van Hauwermeiren: And just a quick follow-up on Ben's figures, if you could just recap the target population, positioning for a Cartesian mod relative to rituximab, and the commercial opportunity that we have in that indication. Thanks a lot. Thank you, Thiago, for the question. You know that we did initiate the CIDP study using the Avgard-Digimod sub-Q product. And initially, that is going to be based on the weekly dosing, Thiago, so we haven't made it yet to an every other week dosing schedule that remains to be explored in the future of that trial or other trials. When it comes to pantyhose competitive positioning, you need to know that pancreas is a very bad autoimmune disease with too few tools and too much oxygen.

Thank you see agro for the for the question.

You know that we did initiate this year the study using the uptick in mobs subcu product.

Initially that is going to be based on the weekly dosing Diego. So we havent made it yet to an every other week dosing schedule that remains to be explored and in the future of that trial or other trials.

When it comes to pass the biggest competitive positioning.

Do you need to noted benthic is is a very bad autoimmune disease with too few tools to looks so today people actually have not much more than hydros corticosteroids, maybe some of the eyes piece and then the to sum up and a bust addiction map of course is amazing innovation in this space.

Tim Van Hauwermeiren: So today people actually have not much more than hydroscopic steroids, maybe some of the ISTs, and then Rituximab. And whilst Rituximab, of course, is a major innovation in this space, which is tough for innovation, it's not a solution for all. We basically see a relatively slow onset of action, so patients need to be managed with high doses of corticosteroids until the effect of Rituximab kicks in. And then we also see a pretty high relapse rate.

Which is stuff that innovation.

It's not the solution for for all be basically see it relatively slow onset of action patients need to be managed with high doses of corticosteroids until the effect of reduction that kicks in.

And then we also see it pretty highly lapse rates. So from a competitive positioning point of view you look at doubled in terms of more tools into tool box not less.

Tim Van Hauwermeiren: So from a competitive positioning point of view, if you look at the world in terms of more tools in the toolbox, not fewer, and I think Evgatigamot is hopefully going to build its own unique proposition based on its rapidity of onset of action, and then, secondly, the ability to taper steroids very fast. So I think that's very complementary to, for example, erythrocytoma positioning.

And I think I've got picked them up is hopefully going to both its own unique proposition based on its rapidity of onset of action and then secondly, the ability to update the steroids very fast so I think thats very complimentary.

To for example, it it takes some up position.

Got it. Thank you very much from some of the progress.

Tim Van Hauwermeiren: Thank you very much. Some progress. Thank you. We will now be taking our next question from the line of Craig Souvenir-Jever from Gold. Go ahead, your line is now: Great, thank you. Good morning.

Thank you.

We will now be taking.

From the line of.

Good.

However from Goldman Sachs. Please go ahead. Your line is now open.

Great. Thank you. Good morning, good good afternoon, I've got two questions and thanks for taking them one I'm curious about 117 in the flavor Jenny Kobin thing Cobot 19.

Tim Van Hauwermeiren: Good afternoon. I've got two questions, and thanks for taking them. One, I'm curious about 117 and the way you're doing COVID-19. When might data be initially available? I know it's early days, but what are you thinking about that? And then the quick follow-up question is, what would the plan be if you actually had positive data? And would that be a combined study setting? And just how are you thinking about the potential further development plan there? And then just one on the model.

When might data be initially available I know, it's early days, but what are you thinking about.

With that in a quick follow up there.

Is what would be the plan if you actually had positive data and would that be a combination study setting. It's just how you're thinking about the potential further.

Development plan, there and then just one on the on the model I know that the guidance is on Opex to continue.

Erica Stalde: I know that the guidance is for OPEX to continue growing. I'm just wondering if there's any lumpiness over the balance of the year in terms of SG&A or R&D as we look out throughout the year. Thank you, Craig, and I will give the second question to Eric in a minute. As for ArgenX17 in COVID-19, this team has been pulling the trial together at record speed in very close partnership and collaboration with the regulators, the Belgian FDA, and our academic partners. So the deal, I think, is that when we have positive data, we will embark on a phase two trial to build on this positive data. But when exactly we're going to release the data remains to be seen. Here in Belgium, for the moment, the COVID-19 epidemic has really cooled off.

Growing im just wondering if there's any lumpiness over the balance will be or in terms of.

SGN, a our R&D as we look out throughout the year. Thanks.

Thank you Craig and I will give the second question to Eric in 10 minutes, so concerning identical in 17 and Coolfit 19.

This team has been pulling the trial together at the record speeds.

Very close partnership and collaborations with the regulators the Bojinov da.

And our academic partners. So the deal I think is that when we have positive data we will embark in a phase two trial to build on these positive data when exactly we going to release data remains to be seen here in Belgium for the moment, the covert 19 epidemic really cooled off.

We have coming gradually out of the look down and experts believe that it's going to be a balancing act between relaxing the measures and seeing get an increase of corporate 19 patients. So it will depend a little bit on how this pandemic is going to evolve and how fast how many patients we can actually get.

Tim Van Hauwermeiren: We are coming gradually out of the lockdown, and experts believe that it's going to be a balancing act between relaxing the measures and seeing, again, an increase in COVID-19 patients. So it will depend a little bit on how this pandemic is going to evolve and how fast, how many patients we can actually get on study, and Eric, I would like to refer to you on the second part of the question regarding R&D and sgene expansion. Absolutely not.

On study.

And Eric I would like to refer to you for the second part of the question regarding R&D and as Ginny expenses.

Absolutely. Thank you Tim So Greg you would see just.

Erica Stalde: Thank you, Tim. So Greg, you will continue to see our ambition level going up as we advance the pipeline, the additional registrational trials we have with SPR TIGEMOD as we start the PINCO development with earlier assets also, and don't forget also the funding of 40% of the QIS-HTGMAP development. So all this will come with additional spans, so definitely the burn rate is going to increase substantially. Thank you. We will now be taking... Any questions from the line of Akash Tewari from Voorthuizen? Have a nice day. Hey guys,

Sorry, you would continue to see.

Our ambition levels going up as we advance.

The pipeline de additional Registrational trials, we have these as gifts you mode.

As we start.

Equally goodwill tweezers assets also earned don't forget we saw the shrinking over 40% of the trees.

So all this will come with additional spend so this is either the building which is going to increase substantially.

Thank you.

Next question from denied access.

From Wolfe Research. Please go ahead your line is now.

Hey, guys.

Tim Van Hauwermeiren: So looking at your phase two MG data, it seems like the MGADL drop didn't plateau after four doses. In fact, if you kept dosing, it felt like you may have been able to drop it a few more points. Can you go over biologically what's going on in these symptomatic patients?

So looking at your phase two Mg data.

Like the MGL job Didnt plateau App your for dose in fact, if you kept dosing. It sounds like you may have been able to drop that you more point can you go over biologically what's going on and the symptomatic patients and what does that mean for your ability to maybe based out the dosing in the long term extension or get pacing and so on into a long term rubbish.

Tim Van Hauwermeiren: And what does that mean for your ability to maybe space out the dosing as a long-term extension or get patients into a long-term remission? Additionally, given your enrolling and more moderate to severe population in the phase three study, is there any reason to believe an FTRN wouldn't show similar efficacy to a C5 inhibitor in this type of severe refractory population? Looking back at the C5 studies, it didn't necessarily seem like a higher MGADL score at baseline led to a greater drop in corresponding scores at the week four endpoint, so I would be curious to get any more color on that.

Additionally.

Given your enrolling more moderate to severe population in the phase three study is there any reason to believe that PRN wouldn't show similar epic the two with five inhibitor and the type of VR refractory population looking back at the by study didn't necessarily seem like a higher MD 80 elsewhere at baseline led to a greater drop.

In corresponding score is app at at the week four endpoint, so I'd be curious to get any color on that thanks.

Tim Van Hauwermeiren: Thanks. Thank you, Akash, for these questions. So the way we configured the dosing schedule for MG in Phase 2 is basically based on the PD curves, the total IgG curves. What you get to see in the Phase 2 publication, of course, is the total curve showing the means for the population we tested, not the individual patient curves. So we have these individual patient curves, and we feel comfortable to basically see that after the last weekly infusion, you max out on your PD effects. This is in sync, by the way, with the Phase 1 data, where we played around with dose and dosing frequency. So we think we have maximized the IgG reduction to the current block of four weekly infusions. Your question on C5 is an interesting one, and actually, there is no scientific or biological rationale why an FCRN blocker would not be able to play in a severe and refractory patient population.

Thank you a cash for this question so the way we configured the dosing schedule for MGM phase two is basically on the PD curves. The total energy curse would you get to see indices to publication of course is the total core.

Showing them the the means for the population we tested love the individual patient curves. So we have these individual patient curves and we feel comfortable.

To basically see that after.

The last weekly infusion you Max out on your.

With the effect that is in seeing by David to Phase one data.

We played around with those and dosing frequency. So we think we have maximized the RG reduction.

Through the current.

Block of four weekly infusions. Your question on C. Five is interesting will actually there is no scientific or biology rationale why an upset and blocker.

Not be able to play in a severe under factory patient population.

Tim Van Hauwermeiren: We all know that complement recruitment is just one of the three pathogenic modes of action of these pathogenic autoantibodies, and actually, we expected by removing these autoantibodies, we should at least have the same effect as a complement blocker, possibly a better effect because we also take care of receptor blockade and receptor cross-linking and internalization, reducing signaling. And we agree with you there is no real correlation from the data we have So I think the jury is still out. Thanks so much. We will now be taking our next question from the line of Derek Archila from Stifel. Please go ahead; your line is now open.

We all know that complements recruitment is just one of the three pathogenic modes of action.

Of these pathogenic ultra antibodies and actually we expected by removing these ultra antibodies, we should at least have the same effect as a complement blocker potentially affect that effectively cost. We also take care of receptor blockade and receptor cross linking and internalization, reducing signaling and we agree with you if there is no.

Real correlation from the data we have all the data we have seen between a disease score.

Andy a delta you can get in terms of LDL or KMG. So I think the jewelry is out there.

Thanks, so much.

We will now be taking our next question from the line us Derrick at Kittila from Stifel. Please go ahead. Your line is now.

Hi.

Tim Van Hauwermeiren: Hi guys, thanks for taking questions and congratulations on all the progress. So just a couple quick questions on MGE and one update on Epidios A3. So on MGE, can you just remind us what the run-in period from the Phase 2 study was for the patients when they were on standard of care? That's a question that we frequently get.

Good question Congrats.

So just a couple quick question not.

One update on.

Yes.

On an as Keith.

Sure. We made some of the seeks to say was hooper.

Well they were on standard of care.

Thats a question what we frequently get and then secondly in the phase three results.

Tim Van Hauwermeiren: And then secondly, in the Phase 3 results, how much information will we actually get on retreatment of the active arms? So thank you for the questions, Derek. I don't know by heart the run-in period for the patients in phase two. I think that's disclosed in the publication. I think we are respecting the standard washout periods.

Much informational, we actually get on Retreatment of the active arm.

So thank you for the questions Eric I don't know by Heart D run in period.

For the patients into phase two I think as disclosed in the publication I think we are expecting to standard washout period.

And I do remember that for.

Tim Van Hauwermeiren: And I do remember that for IgG-based medication, that was six months. What we also said in public is that, on average, a lot of the patients or all of the patients which came into the study had been for substantially longer periods on a stable dose of background medication than the periods which we were requiring according to protocol. So we do know they were on a stable dose, and therefore we do not believe that the background medication or changes in the background medication may have influenced the phase two data. In terms of retreatment information, I think we're still thinking internally about the specifics of the top-line phase three data. Communication, expect us to share primary endpoint analysis, assessments of safety and tolerability, and possibly some trends on some of the secondary endpoints. Got it.

Gee based medication that for six months, what we also said in public is that.

Rich and a lot of the patients are all the patients which came in into study had been for substantially longer periods on stable. Those are big on medication tend to be this retrieval requiring according to protocol. So we do know levered on stable dose and therefore, we do not believe that that back on medication or changes in that.

I got medication may have influenced the phase two data.

In terms of free treatment information I think we still and thinking internally on the specifics of the topline phase three data communication expect us to shed primary endpoint analysis assessment of safety and Tolerability and possibly some trends on some of the secondary endpoints.

Okay.

Got it and then the quick one on pending against I. Just wanted to know as you think about the phase three trial is this something that you're going to bring the equal or is this an opportunity to also bring in the at Haynes Subcu version of it so that trial. Thank you.

Tim Van Hauwermeiren: And then the quick one on PenzmaGIF, I just wanted to know, as you think about the phase three trial, is this something that you're going to bring the IV forward? Or is this an opportunity to also bring the NHANES subcube version of it to that trial? Thank you. Thank you for that question, Derek. So we will be giving more specifics on the Phase 3 trial design later in the year when we disclose that Phase 3 trial design in its totality. We typically like to do that in the context of a KOL event, and we're currently thinking about how we could organize that in today's virtual world. So stay tuned; the details of Phase 3 will be disclosed in the second half of the year. Excellent. Congratulations on the progress and stay safe. Thank you, Derek.

Thank you for that question that acts so we will be.

Giving more specifics on the phase three trial design later in the years, when we disclose that phase three trial design in its totality.

Typically like to do that in the context of Aquia relevant and Weve currently thinking about how we could organize that in today's virtual world. So stay tuned the details of the efficiency will be disclosed second half of to you.

Excellent congrats on the progress and stay safe.

Thank you there.

We will now be taking your next question from the line Matthew Harrison from Morgan Stanley. Please go ahead. Your line is now open.

Tim Van Hauwermeiren: We will now be taking an ex-question from the line of Matthew Harrison from Morgan Stanley. Please go ahead; your line is now open. Thank you. This is Max Goron from Morgan Stanley.

Thank you. This is Mac score on from Matthew Harrison can you comment on the evolving competitive anti of CRM landscape, specifically lexicons decision to advance only the Subcu formulation and also do you have an update on the Subcu bridging study.

Tim Van Hauwermeiren: Can you comment on the evolving competitive anti-FCRM landscape, specifically Alexian's decision to advance only the subcube formulation? And also, do you have an update on the subcube bridging study and timeline for meeting with the FDA? Thank you very much.

And timeline for meeting with the FDA. Thank you very much.

Tim Van Hauwermeiren: So concerning the subcube bridging study, what we said in public is that we have an FDA meeting on our to-do list for this year, where we will actually discuss our proposal and, hopefully, come to an agreement. What we said is that when we have had that meeting and we have received the written minutes, we will communicate to the stakeholders the outcome of that meeting. Now, in terms of the evolving competitive landscape, it is true that we see some shifts in that competitive landscape with the dropout of the acid body molecule and some delays in some of the other competing trials, but I think the big picture, Matthew, is still very much intact. I think there are a few players which have shown Phase 2 efficacy data, and therefore, we only have to navigate so far based on Phase 1 PD data and safety data.

So concerning the Subcu bridging study what we said in public is that we Havent FDM meeting.

On our to do list for this year, where we actually will discuss our proposal and hopefully come to an agreement.

What we said is that when we will have had a meeting and we will have received the written minutes, we will communicate to the stakeholders on the outcome of.

Of that meeting.

In terms of the evolving competitive landscape.

It is too that we see some shifts and that's competitive landscape with a drop out of the assay body molecule and some delays in some of the oldest a competing trials, but I think the big picture Matthew we still very much in tech.

I think that a few players which have shown phase two efficacy data and therefore, we only have to navigate so far based on Facebook on PD data and safety data, but I think we continue to be in an outstanding position.

Tim Van Hauwermeiren: But I think we continue to be in an outstanding position when it comes to differentiation. I think from an efficacy point of view, in our MG, ITP, and PV trials, we've set the efficacy bar very high. And on the safety side of things, it's clear that not all FCRNs are made equal. I think we have a distinctly different and clean profile.

When it comes to differentiation.

I think from an efficacy point of view.

Our Mg DP NPV trials, we've put the efficacy bar very high.

And on the safety side of things, it's clear that not all of shipments are made equal I think we have a distinctly different and clean profile and then I think on the convenience dimension I think it is important to mentioned that we have.

Tim Van Hauwermeiren: And then, on the convenience dimension, I think it is important to mention that we have winning IV execution and probably also winning subcube execution thanks to the HaloZion Enhanced Exclusive License. Please note that we're also differentiating when it comes to trial design and the way we work with patients. I think the ADAPT trial design is unique, it's innovative, and if it is successful, we will actually shape the market through what we are doing in the ADAPT study. And, of course, we also try to stay very close to the MG patient community through initiatives like MyRewardMG. So I think in our efforts to differentiate, we've gone way beyond, I think, a winning molecular design into clinical trial and patient-centric thinking. Thank you. We will now be taking our next question from the line of Yaron Werber from Cohen. Please go ahead; your line is now open. Hi guys, this is Brendan on for your own.

Winning Ivy execution, and probably also winning subcu execution. Thanks to the Halozyme enhance exclusive license mind you to through it also differentiating when it comes to trial designed and the way we work with patients I think the adapt trial design is unique its innovative and if it is successful we will be actually shift.

Up at the markets by what we're doing in the adept study and then of course, we also try to stay very close to the EMG patient community through initiatives like my revolve Angie So I think an hour.

Efforts to differentiate we've gone way beyond I think a winning molecular design into clinical trial and patients Centricity thinking.

Thank you.

We will now be taking our next question from the line.

Werber from Cowen. Please go ahead your line is now.

Hi, guys. This is Brian an unfair around thanks, very much for taking the questions and not correct another great progress SEC.

Keith Woods: Thanks very much for taking the question. And congrats on all the great progress. I actually just really quickly wanted to first ask, actually looking ahead to the ICP trials. Can you just really quickly remind us what the timing of filing there would be?

I actually just really quickly when it's a first as actually looking ahead to the IC trials.

Can you just really quickly remind us what with the timing of filing that would be would you look to file after the first and second confirmatory trials readout or would you wait for the full results of the Subcu trial. Its while like are you are you thinking to launch right at the gate and ATP with that Subcu maintenance regimen.

Keith Woods: Would you look to file after the first and second confirmatory trials readout? Or would you wait for the full results of the sub-Q trial as well? Like, are you thinking to launch right at the gate in ITP with that sub-Q maintenance regimen?

Keith Woods: And then I have a follow-up. Thanks. Thanks, Yaron.

I have a follow up thanks.

Thanks, Cheryl maybe keeps you want to take the first question on the IP trials strategy.

Keith Woods: Maybe Keith, you want to take the first question on the ITP trial strategy? Sure, happy to do so, Tim. So first of all, Brendan, as far as the timing of the ITP trials, Tim did share in the prepared statements that enrollment has slowed a bit due to COVID-19. So we are not in a position to provide firm guidance on what that timing would be. We don't know if we'll see a relapse of COVID-19 that could again slow trial enrollment, so I'm not ready to make a firm statement on that.

Sure happy to do so Tim So first of all Brendan as far as the timing on the GP trials.

Tim did share in the prepared statements that.

Enrollment has slowed a bit due to cobot 19, so we are not in a position to provide.

From guidance on on what that timing would be we don't know, we'll see a relapse of cobot 19 that could it yet again slow trial enrollment so I'm not ready to make a from statement on that.

Keith Woods: In regard to the IV to sub-Q transition, remember, this is where we will use a sub-Q maintenance dose, which is a much smaller dose of efgartigamide. In that third ITP trial, we will put patients in, we will induce them with 10 milligrams per kilogram IV and get them into response, and then the idea is to maintain them. We believe that although that trial is starting later than our first two ITP trials, it will be run concurrently, so concurrently, so there's a possibility that they could all finish up around a similar time. But to answer the question directly, if we find that the sub-Q trial is not ready and we're ready to file with the IV, we will move forward with the first two and continue to subcube. Great. That's super helpful. And then, actually, just one really quick readout on the PV trial readout yesterday.

In regard to the IB to sub Q remember this is where we will use a subcu maintenance dose, which is a much smaller dose of that guard to come on.

That that third eye TP trial, we will put patients. We will induce then what 10 milligram per kilogram Ivy and get them into response and then the idea is to maintain them.

We believe that although that trial is starting.

Later than our our first two ITC trials it will be run concomitant light. So concurrently so there's a there's a possibility that they could all finish up around the similar time, but to answer the question direct if we find that the Subcu trial is it not ready and we're ready to file with.

With the Ivy, we will move forward with the first two.

And continue the Subcu.

Great that's super helpful. Thank you.

And then actually just one really quickly on the on the PV trial readout yesterday.

Keith Woods: Obviously, pretty exciting, the possibility of this steroid-sparing effect. I was wondering, I know you guys had some really detailed information on a few of the patients in the deck. Are we going to maybe get a little bit more granular on the extent to which individual patients are able to taper off steroids? And I guess how you're kind of thinking about showing that in a concrete way, maybe moving forward. Thanks very much.

I, obviously pretty exciting the possibility of this serdes bearing effects I was wondering I know you guys had some really detailed information on a few of the patients in the deck are we going to maybe gets a little bit more granularity on the extensive which individual patients are able to taper off steroids.

And I guess, how you're kind of thinking about showing that.

Great way, maybe moving forward thanks very much.

Keith Woods: Thank you. We already gave quite a little, quite a bit of granularity, I think, in the phase two presentation on the individual patients. When you look at the individual PDI scores and then the three patient anecdotes, which I think are pretty representative of what we're seeing in the trial, I think we had quite a few patients who actually managed to taper off steroids in a pretty impressive fashion.

Thank you, we already get quite a little quite quite a bit of bringing a lot at the I think in the phase two a presentation on the individual patients. When you look at the individual appear the ice course, and then the three patient anecdotes, which I think are pretty representative.

For what are you seeing into trial.

I think we had quite a few patients, which actually managed to taper off steroids.

Pretty impressive fashion.

Tim Van Hauwermeiren: I think we had in total 13 patients out of cohorts three and four where we successfully and aggressively tapered the steroids. I think you will find more detail on this in a publication, which we plan to release the full details of the phase two study. But I think the three patient anecdotes we showed you are pretty representative of what we have seen in cohorts 3 and 4. Okay, great.

I think we had in total 13 patients.

Before three and four where we successfully going aggressively tape it the steroids.

Thank you will find more detail on this in publication, which we would plan to release the food details of the phase two study.

But I think the three patient anecdotes, which we show you a pretty representative for what we have seen in courts three in court for.

Okay, great. Thanks, very much guys.

Tim Van Hauwermeiren: Thanks very much, guys. We will now be taking our next question from the line of James Gordon from JP Morgan. Please go ahead, your line is now open. Hello, James Gordon from Tracey Morgan.

Thank you.

We will now be taking our next question from the line James Gordon from JP Morgan. Please go ahead your line is Sally.

Hello, James Gordon from JP Morgan, Thanks for taking the questions first of all Mississippi empty ahead of the attacked results.

Tim Van Hauwermeiren: Thanks for taking the questions. The first one was just about EFCA MG ahead of the ADAPT results. Just generally, when we go from phase two to phase three, you often get some efficacy deterioration, maybe because of less rigorous patient selection, and then we've got some helpful data about what phase two would look like when you did a six-week responder, but you're doing a four-week responder, which maybe filters less noise, so just when designing the trial, how much weakening were you allowing for, how much buffer Yes, so when we were moving from phase 2 to phase 3, James, of course, we had an opportunity to test drive the primary endpoint definition we would use in the ADAPT study on the phase 2 patient population. We feel comfortable with the responder definition of seeing an at least two-point improvement on the EDL score on at least four subsequent visits in the first eight weeks. I think the separation from placebo is still strong.

Activity when we go from face to face are you looking at summit see deterioration and because the less vigorous patient selection and then we got to help with data about well, let's face. It was like when you did six week splenda, yielding four weeks responder, which maybe feel less noise.

So just when powering the trial, how much weakening when you alone school.

How much buffer if you got lots of the minimum you need to go over the line would be the first question. Please.

Yes so.

But we've been we've been moving from phase two to phase three James of course, we had an opportunity to test thrive the primary endpoint a definition.

We would use in the adult study on the phase two patient population.

We feel comfortable.

With the respond the definition of seeing in at least two point improvement on the L. score.

Leased for subsequent visits in the first eight weeks I think the separation from placebo is still strong I think we have been seeing in public that if you would apply that endpoint on the phase. Two study you would still have a 75% response in the cut ticking about our and it 30% of response in the.

Tim Van Hauwermeiren: I think we have been saying in public that if you applied that endpoint to the phase 2 study, you would still have a 75% response in the F-cartigemod arm and a 33% response in the placebo arm. Our statisticians had the benefit of looking in detail at this data but also the placebo response in the REGAIN study and some of the other small phase 2 proof-of-concept studies. So whilst we haven't been public about the exact powering of the study, I can assure you that we took a pretty conservative approach to the powering of the study.

Placebo arm.

Statisticians have the benefits.

Of looking in digital of these data, but also the placebo response in the regain study and some of the although small phase two proof of concept study. So whilst we havent been public on the expect powering of the study I can assure you that that we took a pretty conservative approach to the powering of the study.

Thank you and then second question taste is just about recruitment in that case studies they see RVP.

Tim Van Hauwermeiren: Thank you. And then the second question, please, was just about recruitment into adherent studies at CIDP. Can you talk about how many patients you have managed to recruit into this study so far? We are not public on the number, but the study is open, as we said in the release. We did not pause the study.

Can you talk about how many patients you have kind of these to accrue into this study cycle.

No public on the number but the study is open as we said in the release, we Didnt have positive study.

Tim Van Hauwermeiren: The study is open, and we are screening patients now. The first patient entered the study already some time ago, and we will continue to screen patients and work towards the 30-patient go-and-go decision point. We always said that this study would run relatively slowly because of the three filters which we installed at the start of the study for patients to go through into Part B, but so far, I think that study is coming nicely out of the gate. Thank you. We will now be taking our next question from Jason Butler from Today MP Securities. Please go ahead, your line is now open. Hi, thanks for taking the questions. First one for Keith, obviously, when you look forward to the launch and you think about potential virtual strategies, are there things that you're doing now with your MSLs that you can, you know, build into your education strategies, awareness strategies to gain some experience with virtual tools ahead of a potential launch? And then, second question, Tim, in addition to the work you're doing with 117 and COVID-19, are you doing any additional work to leverage the platform for antiviral antibodies? There was some work published recently on camelid antibodies and coronaviruses.

Studies opening a screening patients at the first patient entered the study already sometime ago, and we will continue to screen patients and broke towards the 30 patients go no go decision point.

We always said that this study would run relatively slowly because of the three filters, which we installed at the start of the study for patients to go through into part B.

But so far I think Thats study is growing nicely out of the good.

Thank you.

We would now be taking our next question from Jason Lang.

Okay and Securities. Please go ahead your line is now.

Hi, Thanks for taking the questions.

First one for it for key obviously when you look forward to the launch and you think about potential virtual strategies are there things that you're doing now with your M.S. cells that you can.

Filled into your education strategies awareness strategies to gain some experience with virtual tools ahead of potential launch and then second question.

Tim In addition to work you're doing with 117 and Cobot 19.

Doing any additional work to leverage the platform for anti viral antibodies.

There was some were published recently on capital it ends bodies incredible viruses. So just wondering if there's any application for your your simple platform here. Thanks.

Keith Woods: So just wondering if there's any application for your simple platform here. Thanks. Great. Thanks for the question, Jason. In regard to the launch and having to launch potentially in a combination of virtual and in person, as I said, we are learning a great deal right now and fortunate that we're not launching at this time.

Great. Thanks for the question, Jason in regard to the launch and having to launch potentially.

Combination of virtual and in person.

As I said, we're learning a great deal right now.

And fortunate that were not launching at this time. However, we're very active with the medical community you mentioned on our MRM Els and the learning that is taking place right now our mrls are still as well as our thought leader liaison are active with the kolašin in Mg and not only are we.

Keith Woods: However, we are very active with the medical community. You mentioned our MRLs and the learning that is taking place right now. Our MRLs are still, as well as our thought leader liaisons, active with the KOLs in MG. And not only are we able to continue to discuss with them treatment, disease, those that are participating in our trial in regard to our trial, but we're also getting an understanding from them of what they believe the new normal is going to look like on an institution by institution basis. And we're doing a lot of listening right now so that we And unless you create something that meets the needs of the healthcare professional, it's going to fall on deaf ears.

Well to continue to discuss with them.

Treatment disease, those that are participating in our trial in regard to our trial, but we're also getting an understanding from them.

What they believe the new normal is going to look like an institution by institution basis, and we're doing a lot of listening right. Now so that we can develop because I think that you're going to have a lot of companies that are going to be proposing and going with a digital marketing tool and unless you create something that meets the needs of the healthcare profession.

No it's going to fall on deaf ears. So that's how we're utilizing the mrls in CLL is right now is to understand how people want to be communicated to if we are launching in a virtual setting.

Keith Woods: So that's how we're utilizing the MRLs and TLLs right now to understand how people want to be communicated to if we are launching in a virtual setting. And then to the second question, Jason, the answer is simple: it's no. I mean, the news which was seen a couple of days ago relates to an academic initiative by one of the knowledge institutes here in the cluster called VIB. They're working with single domain antibodies from camelids to go after this virus. We have focused specifically on our ability to contribute through our C2 complement inhibitors. So there are no further antiviral or anti-infective initiatives going on in our company today.

And then to the second question, Jason Yes, the simple it's no I mean the.

Yes, which for us.

Seen couple of days ago relates to an academic initiatives.

Five on have done lawlessness that you'd see it into cluster called VIP.

They're working with single domain antibodies off Comminutes to go after this virus.

We have focused specifically on our ability to contribute at through our seat to complement inhibitor. So there are no further.

Anti viral anti infective initiatives going on in our company today.

Keith Woods: Great, thanks for taking the questions. Thank you. We will now be taking our next question from the line of Yatin Suneja from Guggenheim Partners. Please go ahead, your line is now open.

Great. Thanks for taking the questions.

Thank you.

We will now be taking our next question from the line of yes.

Okay.

Please go ahead. Your line is now open.

Hey, guys appreciate the opportunity.

Keith Woods: Hey guys, appreciate the opportunity. Just on the MG Pivotal study, a little bit of a positive surprise that all of the patients have completed the 26-week threshold, probably two weeks earlier than we were anticipating. So could you maybe talk about the next step as you start to lock the database? Do you need any more follow-up beyond the 26-week period on all patients before you announce the data? Any other gating factor before you sort of lock the data and clean it up and sort of announce it and what the timeline might be? Yatin, good to hear from you.

Just on the.

On the energy pivotal study a little bit of a positive surprise that all up the patients have completed 26 week.

Try so.

Probably to each other than we were anticipating so could you maybe talk about the next step Betsy stopped the lock the database.

We need any more follow up beyond the 26 week on all patients before you are not announced the data.

Any other gating factor before you sort of look the data and clean it up and to the pronounce it will depend on might be.

He has been good to hear your thanks for joining today another clinical operations experts. So there are indeed, a number of steps, which have to do with a cleaning data verifying data crosschecking. The data before actually you got to lockett's and just stop it expects the data. So you have onto we absolutely sure.

Tim Van Hauwermeiren: And thanks for joining today. I'm not a clinical operations expert. So there are indeed a number of steps that have to do with cleaning data, verifying data, cross-checking the data before actually you go and lock it, and you start to extract the data. So you want to be absolutely sure about the quality of the database before you freeze it. And we all know that that takes some time.

About the quality of the database before you freeze it and the although that that takes actually sometime so in terms of next steps. These are the routine clinical operations steps, which need to happen to have comfort in the quality of the database, but none of these individually would be specific gating item.

Tim Van Hauwermeiren: So in terms of next steps, these are the routine clinical operations steps that need to happen to have confidence in the quality of the database. But none of these individually would be a specific gating item. It is true that for the top line data, we do need the full depth 26 weeks data sets. But, whilst then, you know, the open label extension study continues, and we will be able to extract safety information from that open label extension study in order to further supplement the BLA filing with the required safety information. Got it, that's helpful. And then just a follow-up on a previous question that somebody asked on the placebo side, so in terms of other trials that have looked at similar endpoints, you know, which is responder rate, and a little bit different than that you have versus what Soliris did, are there other trials that we can look at beside your phase two to get a better understanding of how the placebo might perform in these patients based In terms of the longitudinal LMQMG curves, I would encourage you to really look at the REGAIN study.

It is stood at for the topline data, we do need the full depth 26 weeks data sets.

Last time, you know the open label extension study continues.

And we will be able to expect safety information from that open label extension study.

In order to further supplement to be allay filing with the required safety information.

Got it that's helpful. And then just a follow up on on a previous question that somebody on the placebo side.

So in terms of other trials that have looked at similar endpoint, which is a responder rate and a little bit different than that you have versus whats alluded stage are there. Other trials that we can look at beside your face to get a better understanding of how the placebo might perform in these patients based on that end point.

In terms of the longitudinal elanco CMG curves I would encourage you to read it will go to regain study I mean this is the only.

Tim Van Hauwermeiren: I mean, this is the only decent study published out there, but you can probably expect some learnings. I think the placebo effect which they saw with their inclusion-exclusion criteria resembles the placebo effect which we saw with pretty much overlapping inclusion-exclusion criteria. So I think that this is probably the best study to guide you to it. Thank you very much.

A decent study published out there, but you can probably expect some learnings.

I think the placebo effect, which they saw with that inclusion exclusion criteria resembles the placebo effect, which we saw pretty much overlapping inclusion exclusion criteria. So I think that this probably the best study to guide you towards.

Thank you very much.

Tim Van Hauwermeiren: Thank you. Thank you. We will now be taking one more question from the line of Yana Xu from Fargo City.

Thank you.

We will now take one more question from the line.

From Securities. Please go ahead your line is.

Keith Woods: Hi, thanks for taking the question. The first question is on the ADAPT trial secondary endpoint. How would the results on the secondary endpoints affect approvability? And I'm particularly interested in the 26-week endpoints, which are obviously going to incorporate the effect of flexible dosing. So, just wondering, do you have to hit statistical significance on the 26-week endpoints for a COVID-19 vaccine? Thank you for the question. Keith, would you mind taking this one?

Hi, Thanks for taking the question.

So first question is on the adapt trial a secondary endpoints how would the results on the secondary endpoints effect to approve ability and I'm, particularly interested in the 26 week endpoints.

Which is obviously going for you to incorporate effect of Ah.

Flexpod dozing.

So just wondering do you have to hit statistical significance.

The 26 week endpoints for approval.

Thanks.

Thank you for the question Keith would you mind, taking this won't.

Keith Woods: Yeah, happy to do so, Tim. So first of all, I think probably the most important secondary endpoint that we have there is that this is the first trial to include these seronegative patients. So these musk, LRP4, and agrin patients, although the seronegative population is not a part of the primary endpoint, the primary endpoint is only going to be on acetylcholine receptor positive patients. We did not want to put our phase three study at risk in a patient population that we believe can benefit from F-cardigomod, but we had not tested it in seronegatives yet. So certainly, if that secondary endpoint gives a similar result to the primary endpoint, it can be labeled enabling, and we would be the first and only therapy approved for this population of MG patients, which is about 15% of the total MG population.

Yeah happy to do so Tim So first of all I think probably the most important secondary endpoints that we have there is you know that this is the first trial to include the Ciro negative patients. So these MUSC LR peak for an aggregate patients.

The Ciro negative population is not apart.

The primary endpoint the primary endpoint is only going to be on estill, calling receptor positive we did not want to put our phase three.

Study at risk in a patient population that we believe can benefit from f. garlic, a model, but we had not tested it in cereal negative yet so certainly.

If that secondary endpoint.

Gives a similar result to the primary endpoint it can be label, enabling and we would be the first and only therapy approved for this population of Mt patients, which is about 15% of the total EMG population.

Keith Woods: In regards to the additional secondary endpoints, we will disclose those, and you will see that they will align to further build out and round out the successful primary endpoint by utilizing other scales like QMG and such. To your question about a 26-week endpoint, The primary endpoint is measured in the first eight weeks, okay, and the other endpoints are measured throughout, but as far as statistical significance is concerned, it will occur that the statistical significance of the primary endpoint is observed only in the first eight weeks.

In regards to the additional secondary endpoints.

We will we will disclose those and you will see that they will align to further build out and and round out the successful.

Primary endpoint by utilizing other scales like QM Gi and such.

To your question of a 26 week endpoint.

The primary endpoint as measured in the first eight weeks, okay and the other endpoints are measured throughout but as far as the statistical significance. It will occur. This statistical significance of the primary endpoint is observed only in the first eight weeks.

Got it thanks.

Keith Woods: Thanks for the clarification. And also, another question is on the PENTAGAS data that was just released. So just want to clarify a little bit about the 70% CR rate; I think that is based on 10, who were on optimal dosing, defined as Afghar Tigimod at least every other week, plus a low-dose corticosteroid. But I'm just wondering because Cohort 3 and Cohort 4 had a total of 23 patients, and it seems like the majority of them should have been on at least every other week Af So I was wondering how you arrived at the ten patients and what the reasons were for the other patients not included in the cohort. Thank you for that question. It was only in the last cohort that we actually specified the use of corticosteroids per protocol.

The clarification and also.

Another question is on.

The pencil guest are they a data that was just released.

So just wanted to clarify a little bit about to the 70% CR rate I think that is based on 10 patients who are on optimal dosing.

Fine as Ah that's got to them out at at least every other week plus a load those corticosteroid.

But I'm I'm, just wondering because the cohort three and core for had a total of 23 patients and it seems like the majority of them should be on a at least every other week Africa, arteaga mod and as well as on a load those corticosteroid. So just wondering about.

How you arrive at the 10 patients and what are the reasons for.

The other patients not included in that calculation. Thanks.

Yes. Thank you for that's question. It was only in the last cohorts that we actually specified the use of corticosteroids per protocol.

Tim Van Hauwermeiren: Before that, it was actually at the liberty of the investigators, and we were still triangulating our way through this data to come to the change in the protocol for cohort 4. What you need to know in cohort 4 is when patients reach end-of-consolidation, which is again an important clinical milestone. The patients were given the option to continue into CR or to actually already start to taper off corticosteroids. And that's where we learned the importance of steroid tapering for patients. Actually, that's why we show the third patient anecdote in the presentation, because this is really a representative patient for those who actually elected not to go into CR but to aggressively taper off these hated corticosteroids. For them, it was more important to go to an acceptable level of steroids than it was to go to a PDI score of zero. For those patients who actually opted to continue to go into CR, these are the 10 patients. Indeed, for these seven out of 10 on the optimal dosing regimen, we achieved fast CR.

Before that it was actually at the Liberty of the investigators and we were still Triangulating our way through these data to come to the change in the protocol for cohort for.

What do you need to know in court forward has actually been patients to reach and of consolidation.

Which is again, an important clinical milestone the patients for given the option to continue.

Into CR or to actually already start to taper off a corticosteroids and that's where we learned the importance of steroids tapering for patients actually that's why we showed a third patient anecdote.

In the presentation. Because this is really re presented this patient for those who actually elected not to go into CR, but to aggressively tapered off these hated corticosteroids for them. It was more important to go into an acceptable level of steroids than it was to go through with PD each quarter of zero.

For those patients who actually opted to continue to go into CR additional the 10 patients. Indeed for these seven out of 10 on the optimal dosing regimen, we achieved the fast scioscia. It's based on that information that now actually be can go in craft the efficacy trial design.

Tim Van Hauwermeiren: So it's based on that information that we can now actually craft the phase three trial design. Got it. Thanks for the call. Thank you for the question. We will now be taking our next question from the line of Sandra Kauberg from KBC Securities. Please go ahead, your line is now open.

Got it thanks for the color.

Thank you for your question.

We will now be taking our next question from the line.

From KBC Securities. Please go ahead your line is now.

Keith Woods: Okay, thanks for still squeezing me in and thanks for the update today. I still have a question. I know we touched upon the competitive landscape for FCAR-TGMOT in MG with regard to competitors and late stage trials in FCRN complement space. SubQNIV, but I quickly wanted to touch base as well on the IVIG market. What I've picked up is that this is a market that is quite severely hit today by the COVID pandemic, which might last a little bit into 2021. Is this something that could be of benefit for the positioning of F. Garthie-Gimmott in 2021, so for the launch potential market share? And if I may, still a small follow-up on PV, the adaptive trial afterwards. Sure, Sandra, you're very welcome. Akit, do you want to take question number one, please?

Okay. Thanks for squeezing me in then thanks for any update today.

So have a question I know, we touched already upon the competitive landscape for ask or take a multi men gee with regard to competitors and late stage trials on that CRN compliment states.

Subcu Nic, but I quickly wanted to touch base as well on the idea GE markets or would I pick. It up is that this is a market that is quite severely hit today by the colgate's pandemic.

Which Mike last a little bit into 21.

Is this something that could be outside benefits for the positioning of that Cardigan Matson 21, so for the launch potential market share and if I may still small follow up on PC de adaptive trial afterwards.

Sure somehow you're very welcome Keith you want to take question number one please.

Sure. So thanks for the question Sandra and.

Keith Woods: Sure. So thanks for the question, Sandra. And, um, you know, we have heard a rumor of a potential IDIG shortage. And, as you can imagine, we monitor this situation because it does affect our patient population. Um, in MG, it affects our patient population directly in CIDP. It could have an enormous impact. I don't think we can offer anything other than speculation at this time that the IDIG companies would be able to provide you with much more in-depth knowledge. So I'd rather not comment on what the situation is regarding their supply.

We have heard a rumor of potential ideology shortage.

And as you can imagine we monitor this situation because it does affect our patient population.

In Mg it affects our patient popular directly and see a VIP it could have an enormous impact.

I don't think we can offer anything other than speculation at this time.

The idea GE companies would be able to provide it much more in depth knowledge, so I'd, rather not comment on what the situation is.

Their supply, but we've always said that we believe that Garda gamal can be physician broadly across multiple indications that that IB I'd is utilized into it today and so it does present, a potential increase in opportunity to disrupt the IB AG market.

Keith Woods: But we've always said that we believe F. gardigomide can be positioned broadly across multiple indications that IDIG is utilized in today. And so it does present a potential increase in opportunity to disrupt the IDIG market. Okay, thanks. A follow-up question on PV in the adaptive trial, specifically in the fourth cohort, where I was intrigued by the combination of the tapering of steroids for the dosing there and the increase in F-carotigemod dosing going up to 25 milligrams per kilogram, if I'm correct. And there was some efficacy seen in the skin tissue, which was enhanced. So do you have any learnings that you can extract from that particular part of the study with regard to the mode of action for these patients?

Okay. Thanks.

A follow up question on P.E. on the adaptive trial as specifically on the fourth cohorts, where I was intrigued by the combination of a the tapering for steroids for the dozing, there and the increase in escort taking much.

Dozing going up to 25 milligram per kilogram, if I'm correct.

And there was some efficacy seen on the skin tissue, which wasn't hands. So.

Do you have any learnings.

That you can extract from that particular part of the study with regard to.

To the mode of action for these stations.

Keith Woods: Yeah, this is an interesting question, Sandra. So the ingoing hypothesis was that while everybody's measuring total IgG in circulation, nobody actually knows what happens in the different compartments outside of the circulation. So the skin compartment specifically here is a question, you know, how much of the drug makes it how fast into the skin? We do know that Atgatikamot has a very high volume of pi distribution and is therefore traveling fast.

Yes. This is an interesting question some of the so.

The integration hypothesis was that while everybody's measuring total legislation circulation nobody actually knows what happens in the different compartments outside of the circulation. So the skin compartment, specifically here there's a question.

How much of the drug makes it how fast into the skin.

We do know that uptick in what has a very high volume of by distribution and is therefore traveling fast, but we wanted to see whether it be maxed out the effect in the skin by maybe seeing differences in onset affection for example.

Tim Van Hauwermeiren: But we wanted to see whether we maxed out the effect in the skin by maybe seeing differences in onset of action, for example. The truth is that it's difficult to compare between cohorts 1, 2, 3 and cohort 4 because in cohort 4, we happen to have the most severe patients of all, and therefore it's very difficult to compare, but I think we learned some lessons. We're going to communicate the phase 3 trial design when we will present to you the dose and the dosing schedule for Afghaf Tejemad. So stay tuned on this one. Okay, thanks. We will now be taking our next question from the line of day. Yes, good afternoon.

The truth is it is difficult to compare between cohort 123 in quarter four because in court for we happened to have the most severe patients have all and therefore, it's very difficult to compassion.

But I think we expect that some lessons learnt you're going to communicate inefficiency trial design. When we will present to you to dose of dosing schedule for up to Jim on so stay tuned on this fall.

Okay. Thanks.

We will now be taking questions from the line up.

Sure.

Please go ahead your line.

Yes. Good afternoon. Thank you for taking my question.

Tim Van Hauwermeiren: Thank you for taking my question. I was just wondering why the recruitment in the QTDMAP trials has been late compared to FGAR-TGMOD trials that are still recruiting. Is it a question of indication or geography or maybe something else?

Well just wondering why the recruitment from that to the trials have been both compared to its got to Jim did human trial, Dustin recruiting and it's a question of the indication or Joe Greff, maybe something else.

Tim Van Hauwermeiren: If you could elaborate a bit on this, that would be nice. Thank you. Thank you for that question. I mean, there are two reasons for that.

But at a bar as it becomes is the would be nice. Thank you.

Thank you for that question I mean, there are two reasons for that first of all.

Tim Van Hauwermeiren: First of all, F. gartigiamat is a development plan that is completely under the control of argenx only. And I think we did the benefit-risk analysis for our studies, and we concluded that for F. gartigiamat, it was safe to actually continue to enroll patients. In the Cusatuzumab development, we are 50-50 partners with Janssen.

Thank him up is a development plan, which is completely under control of our genomics only.

And I think we did the benefit risk analysis Forever studies, and we concluded that for Africa pick him up it will save to actually.

Continue to enroll patients into Q, so to sum up development. We have 50 50 promise with Janssen, So we're not making the decision alone.

Tim Van Hauwermeiren: So we're not making that decision alone. And secondly, we need to study, of course, specifically EML patients, who have a very much weakened defense system against infection. Actually, infection is a very high risk of mortality. Therefore, the decision was taken to pause enrollment.

And secondly, we need to study of course, specifically CML patients.

Which has a very much weakened defense system against a infection actually infection is a very high risk of mortality and therefore, the decision was taken to Paul's enrollment and it remains to be seen how exactly and when exactly we can resume enrollment to the trial.

Tim Van Hauwermeiren: And it remains to be seen how exactly and when exactly we can resume enrollment in the trial. Okay, thank you. We will now be taking our final question from Emily Field from Barclays. Please go ahead. Hi, thanks for fitting me in. And I missed the beginning of the call.

Okay. Thank you.

We will now be taking.

Question from Delhi field from Barclays. Please go ahead your line.

Hi, Thanks.

Fitting me and and I missed the beginning of the cause I apologize if I'm asking any questions that could perhaps be redundant.

Keith Woods: So I apologize if I'm asking any questions that could perhaps be redundant. Um, I guess, um, I was just curious. I know you commented on potentially planning for, you know, a hybrid launch, whether it's virtual or totally in person. Sort of along with that, do you have any conversations with FDA? Or do you expect that inspection of any manufacturing facilities could potentially be impacted by COVID if the pandemic were to persist? And secondarily, I don't know if you could talk at all about how you're thinking about pricing, you know, and if any of your thoughts have changed, you know, if there's a potential that we could be entering, you know, a more protracted recessionary environment last year, Thank you. Thank you for these two questions, Emily. So Akita will hand over question two to you in a minute.

I guess.

I was just curious.

Yes, I know you commented on potentially.

Planning for hybrid launched whether its virtual are totally in person.

I started along with that do you.

And the conversations at the a or do you expect that inspection of any manufacturing facilities could potentially be impacted by Colgate, if it's the pandemic or to persist and secondarily.

Could talk at all about how you're thinking about pricing.

And if any of your thoughts have changed.

There's a potential that we could be entering more protracted recessionary environment last year that that's one thing that enters your calculus at all on thank you.

Thank you for these two questions Emily So Keith I will.

Handovers question, a two to you in the minutes.

Keith Woods: With regard to question one, so far, what we have seen and heard from colleagues in the space is that FDA actually continues inspection visits, but they simply do that in a virtual fashion. So we can, of course, not look into the future, but today we know that FDA continues its activities and inspection activities in a virtual fashion. And that's exactly what we are preparing for. And then Keith, would you mind taking on question number two?

With regards to.

Fresh along.

So far what we have seen and heard from colleagues in the space is actually FDA continuous inspection visits, but they simply do that into virtual fashion. So because of course love look into the future, but today, we know thats an FDA continues its activities inspection activities.

In in a virtual fashion and Thats, what VX execs executive adding four.

And then Keith would you mind and taking on question number two.

Keith Woods: Yeah, I'm happy to too. So first of all, when it comes to the pricing of fGuardigaMod, we've said for quite some time that there's a lot of pricing research that we are taking into consideration that we are doing right now. In particular, when we see the data and the overall value to the patient of annual treatment for MG, there's a great deal of information that we're learning that will help us in pricing from our real world evidence study, as well as some of the health economics outcomes research studies that we're doing. We have a large window to price in potentially for MG. If you take a look at the high end of the spectrum where Solaris is, which we will not be pricing near Solaris, and you go down to what it costs for a patient to be on IVIG to treat MG,

Yes happy too.

So first of all when it comes to the pricing F garlic Ahmad.

We've said for quite some time that theres a lot of pricing research that we are taking into consideration that we are ongoing.

Right now in particular, when we see the data and the overall value to the patient on the annual treatment for EMG.

There's a great deal of information that we're learning that will help us in pricing from our real world evidence study as well as some of the health economics outcomes research studies that were doing.

We have a large window to price and potentially for EMG. If you take a look at the high end of the spectrum, where Solaris is which we will not be pricing up near Solaris and you go down to what it cost for a patient to be on IBG to treat Mg. So there's a large window that we can play in Mount to your point about how does cobot, but.

Keith Woods: So there's a large window that we can play in. Now, to your point about how COVID potentially could impact this, What I mentioned before is in the various work streams that we have in our launch readiness, that we are doing all types of scenario play. Well, one of those work streams is obviously pricing and reimbursement. And you can take things into consideration like, will we be looking at a larger population of unemployed? Does that mean there are going to be more patients on Medicaid? How does this affect overall out-of-pocket expenses?

Tensely impact this.

What I had mentioned before as in the various work streams that we have in our launch readiness. We are doing all types of scenario play one of those work streams is obviously pricing and reimbursement and you can take things into consideration like well we'd be looking at a larger population of unemployment does that mean, there are going to be more patients on Medicaid.

How does this affect overall out of pocket expenses. So it is considerations like that that we are taking.

Keith Woods: So it is considerations like that that we are taking in and learning right now and building our various scenarios of where we'll play. And then, finally, the last comment is, as we go to set a price for MG, we'll have a good idea of the progress and success of where we are with our other four indications with Epgardigamon. So that will certainly weigh in.

Learning, taking in and learning right now and building our various scenarios of where we'll play.

And then finally the last comment is as we go to set price for AMG.

I will have a good idea on progress the success of where we are with our you know our other for indications with that Florida come on so that will certainly weigh in.

Keith Woods: That's very helpful. Thanks very much. Thank you. Ladies and gentlemen, this concludes our conference for today. Thank you for participating. You may now disconnect.

That's very helpful. Thanks very much.

Thank you.

Ladies and gentlemen, this concludes our conference for today. Thank you for participating you may now disconnect.

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