Q1 2020 Earnings Call

Thank you for standing by this is the conference operator.

Operator: Thank you for standing by. This is the conference operator. Welcome to the Y-mAbs First Quarter 2020 Earnings Conference Call. As a reminder, all participants are in listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star, then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing stars and zero. I would now like to turn the conference over to Thomas Gad, the Chairman and President. Please go ahead.

How come into the why not first quarter 2020 earnings conference call.

The reminder, all participants earn but said only mode and the conference is being recorded.

After the presentation, there won't be an opportunity to ask a question.

To join your question you May press start than one on your telephone keypad should you need assistance during the conference call you may signal and operator by pressing start and zero I.

I would now like to turn the conference over to Thomas Cat determine and President. Please go ahead.

Thank you.

Thank you everyone for Johnny This call. This morning, Oh, I guess most of US are still virtual hopefully an awful lot.

Thomas Gad: Thank you and thank you to everyone for joining this call this morning. I assume most of us are still virtual, hopefully not for long.

So despite the extraordinary circumstances that we've been through in the first quarter why maps actually had a great quarter <unk>.

Thomas Gad: So despite the extraordinary circumstances that we have been through in this first quarter, Y-mAbs actually had a great quarter of 2020. We believe we've made significant progress on executing our strategy and taking additional steps that will position us very well for a potential product launch of both Exidamate and Burton. We completed the submission of Nacitamide BLA to the FDA in March, as you know, and expect to complete the rolling VLA submission form BIRMAP next month. We are also working very hard on our GD2, GD3 vaccine, which should also expand from a single center trial into a global multi-center trial. From our Y-Biclone bi-specific platform, our first humanized GD2-CD3 bi-specific continues to recruit in a dose escalation single center phase one trial.

And what we believe we've made significant progress on executing on Saturday and taking additional steps double position I was very well for.

Essential product launch <unk>.

We completed the submission Oh, no citizen that P.L.A. to D.S.T.A. March it's you know.

Expect to complete the rolling P.L.A. submission form Birch next month.

We also working very hard on our G.D. to G.D. three vaccine, which should also expand from a single centre.

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From a wide bikes on by specific platform, all first humanize G.D. to C.D. sweep I specific continues to recruit.

You know dogs escalation single sent your face one trial.

Yeah, we could potentially seat data.

Thomas Gad: And here we could potentially see data at SIOP in 2020, and that is in October. We are working on our second bispecific construct from our platform, which is the Humanized CD33-CD3, and here we are planning for a multicenter pediatric AML trial in 2021. And as you know, we filed an IND file, Lutetium Conjugated, Next Generation, on Burismap. Here, the plan is to open a basket trial for all brain metastases coming from primary solid tumors that are B7H3 positive. We ended the first quarter of 2020 with approximately $186 million in cash, so we believe we have a very strong balance sheet to support the potential launch of both Nexidermab and Umberto. While still being able to advance our development pipeline, our cash position should carry us through the end of 2022 without taking into consideration any product sales or any potential partnership income.

In 2020 and that is in October.

You're working on now second by specific construct from our platform, which used to shoot when I see D. 33, C.D. three and here, we are planning boy and multi center pediatric M.L. trial in 2021.

That's you know, we find and and <unk> next generation numbers from that.

And he had the plan is to open a basket trial for all right in the test to see is coming from primary solid tumors that'd be seven h. three plus two.

We ended the fish caught up 2020 with approximately 186 million in cash. So we believe we have a very strong balance sheet.

Supported potential launched both see them <unk>.

Well I still being able to advancing.

Pipelines, Oh cast position she cares to the end up 2022.

Without taking into consideration any product sales well eight potential partnership income.

We're very pleased with <unk>.

To answer position, but bogle elaborate on that laid on this call.

Thomas Gad: We are very pleased with our financial position, but Bo will elaborate on that a little later in this call. As for us, hopefully you have seen by now, on April 15, we entered into a new licensing agreement with MSK and MIT to expand our antibody platform with the SARA technology. And here I would like to refer you to our presentation on our corporate website. We believe the tumor-to-blood ratios obtained in the animal models, based on this side of technology, have never been seen before and may have the potential to improve the current treatment landscape in oncology, opening up to a much broader usage range than any other radiolabing technology in the antibody area.

<unk> hopefully you sold by now on April 15, we entered into a new licensing agreement with M.S.K. and they might see.

To expand all antibodies that phone with the Sadat technology and here I would like to refer you to all presentation on our corporate website.

We believe the too much the plot ratios obtained in the animal models based on this side of technology has never been seen before and may have to potential to improve the current treatment landscaping called you.

Opening up to a much broader usage range and any other Rachel living technology in D.N.T. Buddy area, but class will talk much more about this exciting new technology in a few minutes.

Thomas Gad: But Klaus will talk much more about this exciting new technology in a few minutes. As a company, we continue to work hard to stay true to our position as a leader in pediatric oncology, addressing clear unmet medical needs and focus on advancing our therapies to improve the lives of children living with these rare cancers. It is starting to see, at the same time, our pipeline and technology platform begin to widen its reach into the adult patient population. And with that, I would like to hand it over to Klaus, who will give us a quick overview. Thank you.

As a company we continue to work hard to stay through two opposition has a lead into that you're going quality addressing yeah on that medical needs.

And focus on advancing altarpiece to reach the lives of children living with these we I cancerous.

They're just starting to she at the same time I'll pipeline and technology platform begin to widen it's reach into the adult patient populations.

And with that I'd like to handed over to Klaus cool yeah.

Thank you.

Thank you <unk> and we'll come to why maps Securities first quarter 2020 earnings calls I'm pleased to do you have chosen to join US a day, let me start by saying that we continue to closely monitored the impact of the Kobe 19 on our business.

Klaus: Thank you, Thomas, and welcome to Y-mAbs Therapeutics' first quarter 2020 earnings call. We're pleased that you have chosen to join us today.

Klaus: Let me start by saying that we continue to closely monitor the impact of COVID-19 on our business. We have implemented a number of measures to protect the health and safety of our employees, while also taking steps to advance our operations. These include efforts to mitigate disruption to our supply chain and continue clinical trials and planning of commercial activities. While we expect some near-term impact on clinical trial sites, initiations, and patient enrollment due to the unprecedented challenges posed by the COVID-19 pandemic, we have not changed our major guidelines for key anticipated 2020 clinical trial data readout. To date, we are pleased with the continuity of our business and in our ability to support the critical needs of cancer patients in ongoing trials. However, COVID-19 has created a dynamic environment that may impact the company over time.

Implemented a number of measures to protect the house and they you up I'll employees.

While also taking steps toward montel operations.

Efforts to mitigate disruption to our supply chain and continued clinical trials and planning a commercial activities.

Why do you expect some there to impact on clinical trials Sykes initiation and patient enrollment due to the unprecedented challenges posed by the Kobe 19 pandemic, we have not changed our major guidelines hokey anticipated 2020 clinical trials data redoubts.

It's a date, we are pleased with the continuum continuity of how a business and in L.A. ability to support the critical need of cancer patients in ongoing trials.

However code 19 has created eight dynamic environment that may impact the company or what time, we'll keep investors updated as appropriate going for what.

Klaus: We will keep investors updated as appropriate going forward. During the first quarter, we have continued to work hard to ensure that our two lead product candidates, Maxinimap and UmbertoMap, advance toward the market. In March, as Thomas just mentioned, we submitted the final portion of our rolling BLA for Nexidermab in relapsed refractory norepistoma, and we are now awaiting the potential PDUFA date from the FDA. The BLA is for the treatment of patients with relapsed refractory high-risk norepistoma in bone and or bone marrow. The BLA submission is based on safety and efficacy results from the Pivotal Phase 2 studies 201 and 12238, which we expect to present at a suitable venue later this year. We believe that we have continued to demonstrate our ability to execute on our commercialization plans during the quarter and are excited to submit the company's first ever BLA in less than five years after the inception of the company.

During the first quarter, we have continued to work hard to ensure that I'll have to lead product candidates next to the map and but I've at wants to what the market.

In Moscow is telling US just mentioned we submitted the final portion of all Golding B.L.A. for next to them I mean relapse before I turned hopeless domain and we are now awaiting the potential to do for data from the F.D.A.B.L.A. is for the treatment of patients with laps or factory habeas corpus domain and bone and dog bone marrow.

The P.L.A.'s mission is based on safety ended <unk>, one and talk to study.

We expect to present, a suitable 'cause present that a suitable but then you later this year.

Believe that'd be can have continued to demonstrate hawaii ability to execute an hour commercialization plans during the quota and I decided to submit the company's first yeah, but the L.A. in less than five years after conception of the company.

In addition to the B.L.A. for next it a map we have trials for first line, notably stole my as well as chemo combination trials from the structure I noticed all patients at M.S.K. and in Barcelona.

Klaus: In addition to the BLA for anoxetamab, we have trials for first-line opiostoma as well as chemocombination trials for refractory opiostoma patients at MSK and in Barcelona. During the remainder of 2020, we expect to initiate international Phase II multicenter trials both in frontline and in chemocombination trials. Now turning to Umberto Mapp, our second lead compound. Umberto Mapp is an immunoglobulin antibody rate-to-label for iodine-131.

During the remainder of Twentytwenty, we expect to initiate international please to move to send that trials those in front line and keep the chemo combination treatment.

Now turning to embarrass them up or secondly, <unk> on Burma isn't email the globally, Nancy Buddy Rachel name of with <unk> once or anyone <unk>, we had the P.P.L.A. meeting with the F.D.A. in February this year and we we're very pleased without having our plans confirmed by the agency.

Klaus: From Umberto Mapp, we had a pre-PLA meeting with the FDA in February this year, and we are very pleased with having our plans confirmed by the agency. We expect to complete our rolling ombudsman BLA submission next month for the treatment of patients with CNS leptomeningo-metastases from the oblistoma. This is just a few weeks later than we had originally anticipated back in February after the pre-BLA meeting and before COVID-19 started to affect our activity. We will continue to keep you posted on our progress. We're very pleased to have in-house competence to work on and coordinate the submissions of another rolling BLA only two to three months after completing the submission of the next set of BLAs. In addition to the U.S. development, we are making good progress in Europe also.

We expect to complete <unk> might be lace admission next month for the treatment Duff patients with C.N.N. <unk> metastasis from <unk>. This is just a few weeks. Later then we had originally anticipated back in February after the previous day meeting and before the cool, we'd 19 started to <unk> activities, we will.

Continue to keep you posted on our progress very pleased to have inhouse competence to work on and coordinate this admissions up another rolling P.L.A. only two to three months after completing that submission up the next it I'm not be at I.

In addition to the U.S. development, we are making good progress in Europe also.

<unk> email agreed to propose 12 propose pediatric investigation plan <unk>.

Klaus: In December, EMA agreed to our proposed pediatric investigation plan for ombudma. As part of the regulatory process for registration of new medicines in Europe, companies are required to provide a PIP outlining their strategy for investigating the new product in the pediatric population. An approved PIP is a prerequisite for filing a marketing authorization application for any new product in Europe, and we believe that we now have a clear path for registration in Europe for BertaMap for the treatment of pediatric patients with CNS-Leptomeningo-metastasis from Noblastoma. We plan to submit a marketing authorization application in November this year in Europe. This is a vital step forward in our efforts to bring Humbertum to the market in Europe in 2021.

As a part of the regulatory process for British <unk>, no middle seats in Europe companies I'll be quiet, so provide a peep outlining their strategy for investigation up to new product in the pediatric populations and approved Pip is prerequisite for filing a marketing lots of recession application for any new product in Europe, and we believe that.

We now have a clear pass for registration in euro pumping them up for the treatment of pediatric patients with C. and this led to make a metastasis from noticed on that.

We plan to submit a marketing also we face an application in November this year in Europe. This is a vital step forward you know if us to bring up but I'm up to the market in Europe and 2021.

As previously disclosed we also developing but my foot deep use intrinsic <unk> known as D.I.P.G. interface. One study at M.S.K.N.B. a planning to open then move to send a space to study for D.I.P.D. study in 2020.

Klaus: As previously disclosed, we are also developing, on BurnhamHub, for diffuse intrinsic pontine glioma, known as DIPG, in a Phase I study at MSK, and we are planning to open a multi-center Phase II study for DIPG in 2020. For Desmoplastic Small Round Cell Tumors, known as DSSRCT, we have recently opened a Phase II study at... For our Lutetium-177 radio-labeled Birtimod DTPA construct, we filed the IND back in December 2019, and we expect to open two multi-center Phase I-II studies later this year. One study is in pediatric medulloblastoma, and the other study is a basket study for B7H3-positive CNS-leptomeningo-metastases in adults.

Desmoplastic small rumsfeld swimmers known as D.S.S.S. you'd see we have recently opened to face to study Edelman.

Qualified to teach them 177 radio labeled D.C.P.A. constructs, we filed P.I.M.D. back in December 2019, and we expect to open to move to send the phase one two studies later this year. One study is <unk> and the other study is a basket study could be seven eight.

Street positive C.N.N. slip to make them metastasis in adults.

Well both studies, we hope to utilize all prior experience treating patients with these indications we'd be <unk> <unk> <unk>.

Klaus: For both studies, we hope to utilize our prior experience treating patients with these indications with the iodinated version of Onpetamib. Turning to the commercial part, from our commercial standpoint, we believe we are very much on track to build the right size, best-in-class commercial organization. Given the small universe of pediatric cancer centers that treat the majority of neuroblastoma patients, we believe we can build a lean and highly targeted commercialization organization to launch both maxitumab and ombretumab at approximately the same time. In terms of launch planning, we are very focused on the execution and intent to drive a rapid uptake of both products upon approval and to ensure that we get optimal pricing and reimbursement coverage. Our commercial team is largely in place. As many of you know, we hired our chief commercial officer, Phil Herrmann, about two years ago, and we have been building his team ever since.

Turning to the commercial pot from all commercial standpoint, we believe we very much on track to build the right size based on class commercial organization, given the small universal pediatric cancer centers that treat the majority of the northwest don't want patients. We believe we can build a lean on highly targeted commercialization organization too low.

I don't suppose next to them up and put them up at approximately the same time.

In terms of launched planning, you're very focused on the execution and intend to drive a wrap it up sake of post products on approval and to ensure that would be good optimal pricing on reimbursement coverage.

I will commercial team is largely in place as many up you know we hired old Chief commercial office appeal Herman about two years ago, and we have been building his team ever since.

We have the medical signs license in place in the medical that fast group. So we believe we opposition very well for the potential loans sits next to them up and I brought them up in the U.S.

Klaus: In addition, we have the medical science license in place in the medical affairs group, so we believe we are positioned very well for the potential launch of Nexidermab and Amperdermab in the U.S. Now, that takes us to the SATA technology, as Thomas also briefly mentioned. On April 15th, we announced that we had entered into an agreement with the Morristown Kettering Cancer Center and the Massachusetts Institute of Technology, also known as MIT, for worldwide exclusive license and research collaboration to develop and commercialize antibody constructs based on what we call SATA, self-assembling, disassembling antibody constructs, a radio immunotherapy platform we also describe as liquid radiation. The SATA platform operates in a two-step manner. In the first step, a large saturating dose of the tumor-targeted, unlabeled, bi-specific fragments of antibodies are injected. These bi-specific antibody fragments...

So that takes us to the side of technology S. Thomas also briefly mentions on April 15th we announced that we had entered into an agreement with them lost don't Kid on Kansas and and the Massachusetts Institute of Technology also known as they might see well worldwide exclusive license at least that's collaboration development commercialize antibodies.

Construct based on what we called Saada self assembling a sampling antibody constructs a raid you immunotherapy platform. We also described as liquid radiation.

This out a platinum operates in a two step manner and the first step a lot saturating doe's up to two more targeted <unk> I specific fragments of energy Buddies I injected.

At least by specific Angie Buddy fragments ourselves samples with a link or in vitro quieter injection and creates <unk>.

Klaus: the linker in vitro prior to injection and creates Tetramers, and subsequently binds very strongly to the targeted tumor cells. After a few hours, excess tumor-targeted antibody tetramers that haven't bound to the targeted tumor cells disassemble into smaller antibody fragments and are excreted quickly through the kidney.

And subsequently binds very strongly to the targeted to myself. After a few hours access to more targeted anybody <unk> that haven't bound to the targeted tumor cells. This a sample into smaller antibody fragments and excrete it quickly through the kidneys.

In the second step when the concentration of empty body in mm.

Klaus: In the second step, when the concentration of antibody in the tumor is at its peak and much higher than normal organs, a radio-labeled compound that binds to the pre-localized tumor-targeted antibody is injected and rapidly reaches the tumor, where it specifically binds to the pre-localized bispecific antibody's DOTA-binding part. In published papers utilizing similar approaches but with three steps, data indicate that such processes result in a much higher tumor-non-tumor concentration ratio, which we believe is favorable for radiolabeled therapy since it substantially minimizes radiation damage to normal tissues, which has been the limiting step in the utilization of radiolabeled constructs with antibodies in the past. We believe this approach could improve the efficacy of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents, i.e.

In the tumor is at its peak and much higher than normal organs eight Rachel label compound that binds to the pre localized to more targeted anybody is injected and rapidly reaches the two more specifically binds to the pre localized by specific antibodies dolder finding pod.

In published papers utilizing similar approaches, but with three steps data indicate that such processes results in much higher too much nonchalant concentration ratios, which we believe is favorable Rachel labeled syrupy sense, it's substantially minimized radiation damage to normal tissues, which has been done limiting step in utilization.

Rage labeled constructs with antibodies in the past.

This approach could improve the frequency of redo labels <unk> <unk> that have not historically demonstrated meaningful responses to the racial labels agents I eat tumors with multiple macroscopic lesions larger than three to four centimeters in diameter diameter. As it subsequently allows a higher wage activity level to be injected without impairing.

Klaus: tumors with multiple macroscopic lesions larger than 3 to 4 centimeters in diameter, as it subsequently allows a higher radioactivity level to be injected without impairing hematological toxicity. We intend to initiate the development of a number of SARTA-based constructs created by MSK, including a DD2-SARTA for DD2-positive solid tumors, a DPA33-SARTA for potential use We expect to advance a series of proprietary constructs as well against other targets, and we are targeting to file our first IND next year for a SATA construct and hope to start treating patients with this exciting technology shortly thereafter. These bi-specific antibodies are basically small constructs, about 60 to 70 kilodaltons for each of the four arms of the tetramer, and they consist of two single chain FVs.

Logical toxicity, we intend to initiate development of a number of solder a base constructs created by him is k., including A.D.D. to <unk> <unk> positive solid tumors eight G.P.A. <unk> for potential using colon cancer and her two side of buttons.

He was in breast cancer, although I heard too close to Kansas.

Expect to advance a series of proprietary constructs as well against other targets and we are targeting to file a first 19 next year for a sort of construct and hope to start treating patients with the this exciting technology shortly thereafter.

These by specific antibodies basically small constructs.

[noise] about 60 to 70 keel adult friends for each of the <unk>.

And they consist of two single chain if <unk>. So in many ways each of the arms is like a bytes that many of you may know from emptiness by underside.

Klaus: So in many ways, each of the arms is like a bite that many of you may know from amphibian spinocytes. But obviously, the end that's not binding to the tumor is binding to the radioactive payload instead of directing the T-cells to the tumor. We believe the start-up technology platform makes tremendous sense for Y-mAbs, and it could potentially allow us to unlock even further potential in the field of radiolabeled antibodies, both for specialty oncology indications but definitely also in larger indications. The platform is also available for sub-licensing, and we hope to see the start of technology make a significant contribution to improve the treatment landscape in radioimmunotherapy in the coming years. To support our growth plans, we increased our headcount by approximately 30% during the quarter from 65 to a total of 85 employees.

But obviously.

And that's not binding the too much is binding to their radioactive payload instead of directing the t. cells to the tumor.

We believe the side of technology platform makes tremendous sense from by maps and it could potentially allow us to unlock even further potential into fiendish regulate antibodies. Both her specialty oncology indications, but definitely also in lottery indications that platform is also available for Sublicensing and we hope to see the sonics acknowledging make.

Significant contribution to improve their treatment landscaping raging syrupy.

In the coming years just.

To support our gross plans, we increased our head count by approximately 30% during the quarter from 65 to a total of 85 employees.

They increase is primarily due to addition to the development team as well as a commercial gene that is ramping up on the potential launched with next to them out that but it might.

Klaus: The increase is primarily due to the addition of the development team as well as the commercial team that is ramping up on the potential launch of Nexidermab and Ombertimab. We continue to believe that we are well-positioned to move Nexidermab and Ombertimab to FDA approval and commercialization in late 2020 and concurrently increase our focus on the SATA technology and the earlier stage product candidates in our pipeline, including the lutetium-labeled Ombertimab, the bi-specific programs that Thomas just mentioned, and our DD2, DD3 vaccine, as well as the next-in-line indications for So now, let me invite Bo to share his remarks on the first quarter financial results. Bo.

We continue to believe that'd be a well positioned to move next to them up and bring them up to F.D.L. <unk> and commercialization in late 2020, and concurrently increase our focus on the side of technology and the earliest stage product candidates pipeline, including the <unk> the by specific programs that Tom.

Let's just mentioned and how do you did you do you treat vaccine as well that's the next in line indications for next to them up and I'm, but I'm not.

So now let me invite bow to share his remarks on the first call the financial results. So.

Thank you clowns.

We reported a net loss for the quarter ended March 31st 2020, or 26.2 million or 66 cents per share basic I diluted compared to a net loss of 15.9 billion or 47 cents a share basic interlude is for the quarter into March 31st 2019.

Bo Kruse: Thank you, Klaus. We reported a net loss for the quarter ended March 31, 2020, of $26.2 million, or $0.66 per share basic and diluted, compared to a net loss of $15.9 million, or $0.47 per share basic and diluted, for the quarter ended March 31, 2019. We ended the first quarter with a cash position of $185.8 million compared with a year-end 2019 cash position of $207 million. As our work on the BLA submission for Noxidimab was completed and the Imbertumab BLA submission has progressed, and as we continue to accelerate the commercial ramp-up for the potential launch of these two product candidates, we've seen our cash burn, and we expect the cash burn from operating With respect to the recent announcement of the SADA license, we do not expect this agreement to have a material impact on our spending in 2020.

We ended the first quarter, we to cast position of 185.8 million compared with the yeah. In 2019 case position of 270 million. That's our work under <unk> when I see them up was completed and <unk>.

Something mission has progressed.

As we continue to accelerate the commercial ramp up.

For the potential launch of these two part of candidates we've seen cash for an increase and we expect to cash for income operating expenses for the remaining quarters. It's we see 20 increased slightly what remains roughly in line with a couple of quarters.

With respect to the reason announcement off and solder license, we do not expect disagreement you have material impact when I was spending in 2000, it's windy.

As we take a closer look at the <unk> expenses for the first quarter. We know that I.D. expenses have increased by 6.1 million from 12 and a half million for the court ended March 31st 2019 18.6 million for the quarter ended March 31st 2020.

This increase was primarily attributable to at 2.8 million dollar increase in outsourced research firm supplies to support the expanding development incidences at some point 1 million dollar increase in personnel costs and the point 9 billion dollar increase it outsourcing manufacturing cost primarily related to or to lead part of candidates.

Bo Kruse: As we take a closer look at the operating expenses for the first quarter, we know that R&D expenses increased by $6.1 million, from $12.5 million for the quarter ended March 31, 2019, to $18.6 million for the quarter ended March 31, 2020. This increase was primarily attributable to a $2.8 million increase in outsourced research and supplies to support the expanding development activities, a $2.1 million increase in personnel costs, and a $0.9 million increase in outsourced manufacturing costs, primarily related to our two lead product candidates. DNA expenses increased by $4.4 million from $3.7 million for the quarter ended March 31, 2019 to $8.1 million for the quarter ended March 31, 2020. The increase in DNA expenses primarily reflects a $1.6 million increase in personal costs and $1.6 million increase in the building of our commercial infrastructure related to the potential launch of our two lead product candidates. Oh, next to the mouth and on the bottom.

D.N.A. experiences increased by 4.4 million from 3.7 million for the quarter ended March 31st 2019 to 8.1 billion fourth quarter ended March 31st 2020.

Increase in G.N.A. experiences primarily reflects at 1.6 million dollar increase in personal costs.

A a 1.6 million dollar increase in the building Oh commercial infrastructure related to the potential launch Oh to lead product candidates.

Next cinema in about a month.

Cash flows from operating activities in the first quarter of 2020 showed that the cash for an increase by 8.3 million from 13.5 million for the quarter ended March 31st 2019 21.8 million for the quarter ended March 2020 <unk>.

The increase was primarily caused by the increase in the net loss for the the net loss itself increased by 10.2 million for the quarter ended March 31st assessments, Wendy and was partially offset by an increase in non case expenses, including depreciation and stuff based compensation of 1.4 million.

Bo Kruse: Cash flows from operating activities in the first quarter of 2020 show that the cash burn increased by $8.3 million from $13.5 million for the quarter ended March 31, 2019, to $21.8 million for the quarter ended March 31, 2020. The increase was primarily caused by an increase in the net loss for the year. The net loss itself increased by $10.2 million for the quarter ended March 31, 2020, and was partially offset by an increase in non-cash expenses, including depreciation and stock rate compensation of $1.4 million. In terms of financial guidance, we've said since the secondary offering in November last year that cash on hand plus the net proceeds from the offering would cover our operating activities and capital expenditures through the fourth quarter of 2022. And this still does not take into account any potential revenues from the commercialization of MaxitaMap and AlbertaMap or the proceeds from any potential future partnerships. So we continue to believe Y-mAbs remains in a very healthy financial position. This concludes the financial update, and I'll now turn the call over to Thomas.

In terms of finance guidance, we've said since the secondary offering in November last year that cash on hand, plus the net proceeds from the offering would cover or operating activities and capital expenditures through the fourth quarter of 2022, and there's still does not take into account any potential revenues from commercial.

I'd say she enough next you to map at a bottom up all the proceeds from any potential few.

Future partnerships. So we continue to believe why matched remains in a very healthy financial position.

This concludes the financial updates.

<unk> over to Thomas.

Thank you bow and saying Clausen, yes. Thank you both thank you Klaus this.

It's marks the end or well prepared remarks, and thank you very mountains around for being available and spending time on why not call and I'll turn it over to the operative cool too and I. Thank you.

Thank you well now begin the question and answer session to join a question you May press start than the one on your telephone keypad you won't hear a tone acknowledging your request. If you are using a speaker phone. Please pick up your handset for pressing any keys.

Here with dry your question. Please press start tend to.

Paused for a moment as colors during the queue.

Our first question comes from Alex Trendy and it's Bank of America. Please go ahead.

Okay. Thanks for taking my questions and glad to hear your all doing well I meant stop everything that's going on with with co bed.

Thomas Gad: Thank you, Bo, and thank you, Klaus, and yes, thank you, Bo, thank you, Klaus. This marks the end of our prepared remarks, and thank you very much, everyone, for being available and spending time on Y-mAbs' call. I'll turn it over to the operator for Q&A. Thank you.

So so on that note.

Thanks for the color on the cover it impacts their business, we've been hearing from companies across the industry that covert 19 isn't really impacting F.D.A. review of N.D. is that much at this time, but it is affecting how quickly clinical studies the crew but of course this depends on on disease area.

Operator: Thank you. We will now begin the question-and-answer session. To join the question queue, you may press star, then 1 on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star and two. We will pause for a moment as callers join the queue. Our first question comes from Alec Stranahan with Bank of America. Please go ahead.

So could you provide any insights you've gotten from recent interactions with the F.D.A. that could inform review timeline do you think you're close relationship with M.S.K. and the need within second and third bite on call G. could help you'd be a bit more inflated in terms of impact your clinical studies you to cover.

That's my first question that I have a follow up.

[laughter].

Alec Warren Stranahan: Hey guys, thanks for taking my questions and glad to hear you're all doing well amidst everything that's going on with COVID. So, on that note,

Thank you Alec and thanks for joining in in terms of all F.D.A. into action I have to say, they're extremely open and collaborative still and and seems to be definitely open for business. You have had a number of transactions with them in the last couple of months also on on the telephone basis, and and written basis. So so.

Alec Warren Stranahan: [inaudible]

Alec Warren Stranahan: Thanks for the color on the COVID impact on your business. We've been hearing from companies across the industry that COVID-19 isn't really impacting FDA review of NDAs that much at this time, but it is affecting how quickly clinical studies accrue. But of course, this depends on the disease area. So could you provide any insights you've gotten from recent interactions with the FDA that could inform review timelines? And do you think your close relationship with MSK and the need within second and third line oncology could help you be a bit more insulated in terms of impact on your clinical studies due to COVID? That's my first question. Then I have a follow-up question.

The only thing you can say that potentially could impact the L.A. filing says that they have said that they are not doing overseas.

P.L. ice.

But.

I think that's for now until the end of this month.

However, they will have four next to them up two additional pose abilities. They have we had having batch manufacturing's ran in.

May August on October this year, so it should be possible for the F.D.A. to to do in the P.L.I. Other in August Oct. If they do not do the P.L. I hear late they had something ignored plan. So I'm I'm quite comfortable and alternative that they could do a virtual p. ally, where they just sit on the bitter.

That's where the staff and get all the documentation. So I have to say I agree the F.D. into actions are continuing <unk>, we're told manner, but definitely continuing at full speed on the technical impact side I I mean for the regulatory purpose of getting a pool palm put them up and next to them I don't think it's being.

Klaus: Thank you, Alec, and thanks for joining in. In terms of our FDA interaction, I have to say they are still extremely open and collaborative and seem to be definitely open for business. We have had a number of interactions with them in the last couple of months, also on a telephone basis and in writing. So the only thing you can say that potentially could impact the LA filings is that they have said that they are not doing overseas PLIs, and I think that's for now until the end of this month. However, they will have, for Nexidermab, two additional possibilities.

Impacted by the.

Say.

Ah reduce clinical trial activity, that's definitely happening at the side, but it doesn't mean that you're not seeing patients coming into our studies, we definitely seeing patients coming into other studies every month, but it's more difficult to initiate new clinical trials, because sending people out doing side initiation visits and things like that that's a bit more tricky these days.

I eat is not possible. So so that part of the development will be affected so some clinical trials may started little later than we had hoped for but but continued data collection and and these things will continue as planned.

Klaus: They have appeared to have batch manufacturing plans in May, August, and October this year, so it should be possible for the FDA to do the PLI either in August or October if they do not do the PLI here in late May as originally planned. So I'm quite comfortable, and alternatively, they could do a virtual PLI where they just sit on a video conference with the staff and then get all the documentation. So I have to say I agree the FDA interactions are continuing in a virtual manner but definitely continuing at full speed. On the clinical impact side, I mean, for the regulatory purpose of getting approval for Brunnermab and Nexidermab, I don't think it's being impacted by the, you can say, reduced clinical trial activity that's definitely happening at the sites, but it doesn't mean that we are not seeing patients coming into our studies.

Did that answer the question.

Yeah. That's very helpful thing and then just one follow up if I may.

Sure I believe you missed on this on your R. and D. day last year, which seems like ages ago at this point, but could you give us a sense of the extent of G.D. two expression in different tissues in the body and maybe the the hurdles that needs to be overcome to target T.D., two and tissues outside of no blastoma. Thanks.

Well I mean, there's no doubt no plus domas seems to be several fold higher in T.V. two expression on that breaks I would say it's in the ballpark five to 10 fold higher than other too much subsets, most have lung cancer and so coolness.

So so for a naked antibody to have activity.

Outside of no bus stole my end eventually osteosarcoma it could be a P.L.N., whereas if you have it by specific games, but he'd like the G.D. to G.D.H.C.D. tree anybody we have that is much more potent in its activity you know in vitro essays Oh by specific did you choose C.D. three in the presence of T. cells is about.

Klaus: We're definitely seeing patients coming into our studies every month, but it's more difficult to initiate new clinical trials because sending people out doing site initiation visits and things like that is a bit more tricky these days. It's not possible, so that part of the development will be affected. So some clinical trials may start a little later than we had hoped for, but continued data collection, and these things will continue as planned. Did that answer the question?

10000 fold more potent than than the next set them up anybody using the prices up in case else. So I think for those kind of construct so well for I.D.D. two solder construct I don't think that <unk> really mad us, but but that foreign aid kit I.T.T. one antibody that's intended to initiate.

Klaus: And then just one follow-up, if I may. I believe you touched on this on your R&D day last year, which seems like ages ago at this point, but could you give us a sense of the extent of GD2 expression in different tissues in the body and maybe the hurdles that need to be overcome to target GD2 in tissues outside of neuroblastoma? Thanks.

80, C.C. I think it matters.

And that makes sense.

Yep, that's perfect I fought.

Right next question comes from at third Tara.

Securities. Please go ahead.

[noise] great. Thanks for taking the like questions. So cool Oh for me it sounds like a delay for murder map was mainly driven by covert dynamics interest wondered if you had.

Klaus: Well, I mean, there's no doubt noblestoma seems to be several fold higher in GD2 expression on average. I would say it's in the ballpark of 5 to 10 times higher than other tumors such as small cell lung cancer and sarcomas. So for a naked antibody to have activity outside of neuroblastoma and eventually osteosarcoma, it could be a challenge, whereas if you have a bispecific antibody like the DD2-CD3 antibody we have, that is much more potent in its activity in our in vitro assays. Our bispecific DD2-CD3 antibody in the presence of T cells is about 10,000 times more potent than the maxitumab So I think for those kind of constructs or for a DD2 starter construct, I don't think the lower expression level really matters, but for a naked IgG1 antibody that's intended to initiate ADCC, I think it matters. Did that make sense?

Any other interactions with the agencies as your <unk> B.L.A. meeting in the saddle technologies.

See very very interesting interest wonder in terms of sort of the constructs that could potentially I'd 20 and 2021.

Is is the sort of the G.D. two side the the front runner here for for the next I'm for the first Cindie.

And I have a follow up.

Okay sure just to summarize the on photo lab F.D.A. into action after the P.P.L.A. meeting the the only into action to the best of my recollection is that when you do it rolling P.L.A.U. informed D.S.T.A. that you are starting it and that you are having this plan for when you will submit.

The various document so they have the resources available and that into action has been submitted an accepted by the agency. So so they are pretty clear on what to expect from outside besides that has been messing I think they they think that I've taken a little longer than than anticipated has been x. turnover into delivery of some also reports.

Klaus: Yep, that's perfect. Thanks a lot.

Whether it be like I I have to say the.

Etzer Darout: Our next question comes from Etzer Darout with Guggenheim Securities. Please go ahead. Okay.

The regulatory team here at why maps has been tremendously efficient working on it from remote places and fortunate being the last couple of weeks out of the daily soap is we have been able to start a working some days per week and getting back to a little little normal situation here in terms of the <unk>.

Etzer Darout: Great. Thanks for taking my questions. So, a couple for me.

Etzer Darout: It sounds like the delay for MurdaMap was mainly driven by COVID dynamics, and I just wondered if you had any other interactions with the agency since your pre-BLA meeting. And the data technology, you know, seems obviously very, very interesting. And I just wondered, in terms of sort of the constructs that could potentially IND in 2021, is this sort of the GD2 SADA, the front-runner here for the next – for the first IND?

<unk> the the first one but most likely will go into clinic again, depending on toxicology et cetera would be the T.V. two solder.

Which is the one that the actually started out all of this and since we already had a license with M.S.K. to all that you to chew constructs. They were kind of like Hey, you guys wouldn't be interested in in a thought to construct and then the discussion started that we ended up making this license. So so yes, that's the most advanced one.

Klaus: Okay, sure. So just to summarize, the OmbertaMap FDA interaction after the pre-BLA meeting, the only interaction, to the best of my recollection, is that when you do a rolling BLA, you inform the FDA that you are starting it and that you have this plan for when you will submit the various documents so they have the resources available. And that interaction has been submitted to and accepted by the agency, so they are pretty clear on what to expect from our side. And besides that, there has been nothing.

And I would definitely expect to have an I.D.U.I.D. next year and I would definitely also cross my fingers and do whatever I came to see this coming into patients already next year. This is for me probably the most exciting technology that I've seen in the last 35 year olds in terms of Kansas therapy.

Type of Golden bullets, that'd be have been looking for since Creelan millstein publish that paper in the seventies about how to create multiple antibodies before we were really paying attention to him and all of G. and Immunogenicity and all these things that that turned out. This is this could really be a serious game change in in a <unk>.

Klaus: I think the things that have taken a little longer than anticipated have been external vendor delivery of some of the reports we need for the BLA. I have to say the team, the regulatory team here at Y-mAps, has been tremendously efficient in working on it from remote places, and fortunately, in the last couple of weeks out of the Danish office, we have been able to start working some days a week and getting back to a little more normal situation here. In terms of the SATA construct, the first one that most likely will go into the clinic, again depending on toxicology, et cetera, would be the DD2 SATA, which is the one that actually started all of this. And since we already had a license with MSK for all the DD2 constructs, they were kind of like, hey, you guys wouldn't be interested in a SATA construct. And then the discussion started, and we ended up making this license. So yes, that's the most advanced one.

Just in the pediatric setting, but basically for everything you have a solid tumor target that as well validated that is selectively expressed on the came so you can get ranges up up to 100 fold more radiation, maybe you can 500 for more radiation to the to target then do suitable normally issues at risk.

This could be a fantastic breakthrough in Kansas or a p. in my my personal opinion.

<unk> Yep Yep. Thank you Oh, yeah. It just it sounds like the the by specific data or the the dose escalation of it would be at so I just wondered if we're still planning to move forward with the phase two programs later this year with with the but the the the.

Runner by specific.

Absolutely definitely clear, yes, [laughter] so.

Klaus: And I would definitely expect to have an IND ready next year. And I would definitely also cross my fingers and do whatever I can to see this coming into patients already next year. This is, for me, probably the most exciting technology that I've seen in the last 35 years in terms of cancer therapy. This is the type of golden bullet that we have been looking for since Krueger and Milstein published their paper in the 70s about how to create monoclonal antibodies before we were really paying attention to immunology and immunogenicity and all these things that have turned out. This could really be a serious game changer in oncology, not just in the pediatric setting, but basically for everything. To have a solid tumor target that is well-validated, that is selectively expressed in the cancer, you can get ranges of up to 100 fold more radiation, maybe even 500 fold more radiation to the tumor target than you do to the normal tissues at risk. This could be a fantastic breakthrough in cancer therapy, in my personal opinion. And you had a follow-up to that.

Well, we I think we are still we already know what adults level, where I'm comfortable putting it into place to studies.

Great well thank you.

Congrats on the update.

Thank you.

Our next question concerning Robert Burns with H.C. Wainwright income. Please go ahead.

Hi, guys. Thanks for taking my questions and congratulate all the phenomenal progress you guys are making a two questions for me if I may 1st one being you know obviously, we know the expensive collaboration that you have with M.S.K. and in the context of neuroblastoma I was curious as to how many other tear one prescribers outside of M.S.G.I.

There are within the U.S. and how fast you believe you could actually target them upon approval of <unk> and then my second question is in regard to some of the stuff that we're going to see it asks go 2020, I noticed that where there's a <unk> poster being presented a and I was curious what sort of.

Incremental updates can we expect to see within that data set ASKO. Thank you.

Yeah.

Okay, Great that first one M.S.K. sees about 15% of all the new Augusto my patients as far as we can pick you out in total I would say that that 80% of of all the nodes are still my patients treated then in less than 80 sites in the U.S. how quickly we can.

Etzer Darout: Yep, yep. Thank you. Yeah, it sounds like the biospecific data or the dose escalation update would be at SAIA. I just wondered if we're still planning to move forward with the Phase 2 programs later this year with the frontrunner biospecific data.

Penetrate into these sides I mean, we will probably have about 10, a sales representatives available and and we have <unk> have five medical fans license out there to work with the sides I think we would be able to penetrate that pretty quickly I mean, there's a limit to how many times during a month or you can visit the same side as a sales reps.

Klaus: Absolutely, definitely, a clear yes.

Etzer Darout: Thank you.

Klaus: I think we're already at a dose level where I'm comfortable putting it into Phase 2 studies. Great.

Etzer Darout: Great. Well, thank you, and congrats on the update.

Klaus: Thank you.

Robert John Burns: Our next question comes from Robert Burns with HC Wainwright & Co. Please go ahead.

Terrible as a medical science license. So so I think we are <unk>.

Robert John Burns: Hi guys, thanks for taking my questions and congrats on all the phenomenal progress you guys are making. I have two questions from me, if I may.

Definitely capable of of getting through to everybody in the first six months.

After launch well they didn't start using it I mean time will show the there's of course no guarantees in anywhere, but I I think we have so many good advises we've you know where there's a number of times about the shoulder infusion time left side effects, then I talked to map and Oh, no need for using I'll too and and soap on.

Robert John Burns: First one being, obviously, we know the extensive collaboration that you have with MSK and, in the context of neuroblastoma, I was curious as to how many other tier one prescribers outside of MSK there are within the US and how fast do you believe you can actually target them upon approval of noxidimab? And then my second question is in regard to some of the stuff that we're going to see at ASCO 2020. I noticed that there is a noxidimab poster being presented, and I was curious, what sort of incremental updates can we expect to see within that data set at ASCO? Thank you.

So so that's pretty clear.

In terms of what to say about the Esko data I think we had just blows the titles and as soon as the the full data set becomes available we will disclose that but it will be investigate.

Evaluated the information from the pivotal studied 12 to study. So so that's an update on that.

Klaus: Okay, great. The first one, MSK sees about 15% of all neuroblastoma patients, as far as we can figure out. In total, I would say that 80% of all neuroblastoma patients are treated in less than 80 sites in the U.S. How quickly we can penetrate these sites, I mean, we will probably have about 10 sales representatives available, and we have four, and we'll have five medical sales licenses out there to work with the sites. I think we will be able to penetrate that pretty quickly. I mean, there's a limit to how many times during a month you can visit the same site as a sales representative or as a medical science licensee. So I think we are definitely capable of getting true to everybody in the first six months after launch. They didn't start using it, I mean, time will show, there's, of course, no guarantees on the web, but I think we have so many good advantages.

But but and and dust up to more study also.

But we haven't said any more given any more details about that yeah, we'll definitely as soon as the data is available we will press release it.

And that should talk them very quick.

Yeah.

Yeah.

Alright.

Right next question comes from David Lebowitz Morgan Stanley. Please go ahead.

Oh, Thank you very much for taking my question. When you look at the next to the Mad submission given that <unk> bleep rubber factory, but frontline data been available given population still small how do you think the F.D. is going to look at the front line data, especially given that there will be more updates and there's some.

Frontline trial under way and I guess, what do you think the timeline for something happening on the front lines side might be.

Thanks, David for joining us and for the question. It's a good question. So so the front line data to correctly said, we presented the first set of data from 37 patients in front line treated by Dr. More in Barcelona, There's a second single send to study ongoing at M.S.K. that has more than 50 patients included.

Klaus: We've been over this a number of times about the shorter infusion time, less side effects, and the panotoxin map and no need for using IL-2 and so forth and so on. So that's pretty clear. In terms of what to say about the ASCO data, I think we have disclosed the titles, and as soon as the full data set becomes available, we will disclose that, but it will be investigator-evaluated information from the Pivotal Study 12-30. So there's an update on that, and then there's Dr. Moore's study also. But we haven't given any more details about that yet. We'll definitely, as soon as the data is available, make a press release about it. And that should be all.

And I certainly hope you'll have those data available later this year. This strategy in terms of getting next cinema approved in front line formally by the F., yeah use to wait until they have approved it and second line and then off the agency for a type b. pre B.L.A. or.

Whatever strategy advisory meeting.

And presented them the data from top to more study in Spain. The data from the singles and started saying listen to study at M.S.K. and.

Up a protocol that'd be a currently in in preparation for that should start recruiting patients in second half this year.

Klaus: All done very quickly. Thank you. Thank you. Bye-bye, everyone.

David Matthew Nierengarten: Our next question comes from David Lebowitz of Morgan Stanley. Please go ahead.

Whoopee, starting to recruit patients when we go to the F.T.A. because that say the F.D. I approve a next to them up in November and wouldn't be asked for a meeting to discuss the front line and that means that we if we ask for that in November we will get the meeting 60 days later, which will be in January so at that time point, we can also share with the agency.

David Matthew Nierengarten: Thank you very much for taking my question. When you look at the Nifedimab submission, given that the submission technically is for refractory, but front-line data has been available, and given the population is still small, how do you think the FDA is going to look at the front-line data, especially given that there will be more updates and there's another front-line trial underway? And I guess, what do you think the timeline for something happening on the front-line side might be?

We have this more extend the protocol in front line ongoing and here, we can provide this and that they don't pay to later this year.

So I think with those three studies at hand, I think the discussion with the agency should.

Also be generated here passports shop commentary P.L.A. and from time.

Klaus: Thanks, David, for joining us and for the question. It's a good question.

But that's my strategy I'm not going to rock the boat in front line discussions with the F.D.A. before they have a pool the second line.

David Matthew Nierengarten: So the front-line data, as you correctly said, we presented the first set of data from 37 patients in front-line treated by Dr. Moore in Barcelona. There's a second single-center study ongoing at MSK that has more than 50 patients included, and I certainly hope that we will have those data available later this year. The strategy in terms of getting Nexidimab approved in front-line formally by the FDA is to wait until they have approved it in second-line, and then ask the agency for a type B, pre-BLA, or whatever strategy advisory meeting, and present to them the data from Dr. Moore's study in Spain, the data from the single-center study at MSK, and the design of the protocol that we are currently in preparation for that should start recruiting patients in the second half of this year, and we'll be starting to recruit patients when we go to the FDA, because let's say the FDA approved Nexidimab in November, then we asked for a meeting to discuss the front-line, and that means that if we ask for that in November, we will get the meeting 60 days later, which will be in January.

It it's just going to confuse to pick.

And I think two singles into studies in the movies tend to study.

And the two singles into studies already basically being finished and then we'll just have to study to stop and we'll make six months.

You should be in a strong position to discuss with the agency and we will definitely have sufficient.

They are awful.

Going and pretends or a off mobile.

I would guess that supports apology.

Yeah that was actually believe my next question. So you would expect you would anticipate that.

She was probably just given.

Comparison dying you talk some AD I will probably just on their own makes their own adjustments irrespective of approval.

Well.

M.S.K. have never so the best of mind always used diner talks about not out in front line on second line I. It would be hard for me to see why they would suddenly start doing that just because their own product came to the market. So and they are by far the biggest noticed almost into new us having said that and it's also.

<unk> I mean, if it was your own kit.

And and you saw the two compounds.

Next to each other and you could see there was data from two separate clinical trials. It's out then then we'll just send to study ongoing.

Then you could pick and choose between which one that you own Kid would get I wouldn't hesitate I mean that I would give my son or daughter definite next to them up treatment.

David Matthew Nierengarten: So at that time point, we can also share with the agency that we have this multi-center protocol in front-line ongoing, and here we can provide this and that set of data later this year. So I think with those three studies at hand, I think the discussion with the agency should possibly generate a clear path for supplementary PLA in front-line. But that's my strategy. I'm not going to rock the boat in front line discussions with the FDA before they have approved the second line. It's still kind of confusing to pick, and I think two single-center studies and a multi-center study, and with the two single-center studies already basically finished, and the multi-center study to start in the next six months, we should be in a strong position to discuss with the agency. And we will definitely have a sufficient amount of data out there for contingent listing and potential off-label use.

The member also the kids did we get treating almost none of them gets a bone marrow transportation.

And <unk> presentation et cetera that should be some update on that also at at school coming up next week.

I don't see why these kids bone marrow transplants, but that's a very sensitive discussion on in no up a storm a pediatric on call.

I guess when one of the question would be is on the basically agreement, saying do you see it over the long haul.

This I guess displacing.

The <unk>.

Labeled technology or is this something that would be supplemental too.

I I think it's going to be extremely difficult to supplement or to to substitute but in the first indications because you would have to do studies.

In patients and and you know.

David Matthew Nierengarten: Cheers.

When you give compartmental treatment for Rachel Nabel antibody.

David Matthew Nierengarten: Yes, that's supposed to go. That was actually going to be my next question.

And then local toxicity doesn't seem to be an issue.

David Matthew Nierengarten: You would anticipate that... Physicians have probably just given the comparison of Dianetuximab and will probably just on their own make their own adjustments irrespective of approval.

So so I think it's it's probably not going to be the case that people would place compartmental use of <unk>.

But you know and like for anything else I mean, that's that's one of the big challenges have had to learn true my 35 years, plus and the pharmaceuticals.

Klaus: Well, MSK has never, to the best of my knowledge, used dinotoximab, neither in the front line nor in the second line. It would be hard for me to see why they would suddenly start doing that just because their own product came on the market. And they are by far the biggest Nervous Tumor Center in the U.S. Having said that, and it's also... I mean, if it was your own kid and you saw the two compounds next to each other, and you could see there was data from two separate clinical trials that are out there and a multi-center study ongoing, then you could pick and choose between which one your own kid would get. I wouldn't hesitate,

Industry, you always come up with something that smarter than what you already have and that may not even have reached the market yet and if you don't continue developing and get the product that you already working on Finnish.

To the market and stop selling it you are bankrupt before the much better worse than ever comes anywhere. So you know as well as I do with that although this out of constructs may come into patients over the next year. If we can get even one of them approved in the following eight years, we are extremely fast extremely fast and eight years from that that's 2029 or ages from next year.

So so I think.

I'm sure. She I think I can be about these constructed would never make me a band in any of the stuff that we're working on already that isn't patients that isn't clinic that is close to be late filings already P.L.P. file.

That is the future and it takes time to read the future.

Thank you for answering my questions.

Klaus: I mean, I would definitely give my son or daughter an Excedermab treatment. Remember also, the kids that we are treating; almost none of them get bone marrow transplantation. And there's a pending presentation, et cetera, but there should be some update on that also at ASCO coming up next week. I don't see why these kids need bone marrow transplants, but that's a very sensitive discussion at Northwestern Pediatric Oncology.

Sure.

My next question comes from Boris P. curve, which Cohen. Please go ahead.

Oh good good morning, first I just want to know from the market perspective, what fraction of pediatric nearby stone patients are treated with unit talks and and how do you see you know your message being kind of what competitive marketing could unituxin a manufacturer to.

As you get a good amount approved.

Well I mean, it if you take this sales numbers it looks like they're giving about 600 almost for patient treatments per year and per year in the U.S. as about 800 to patients diagnosed with <unk>.

Klaus: And I guess one other question would be on the license agreement with SADA. Do you see, over the long haul, this, I guess, displacing the Umbrtomab radio-labeled technology, or is this something that would be supplemental to it?

Klaus: I think it's going to be extremely difficult to substitute Burma in the first indications because you would have to do studies, inpatient, and you know, when you give compartmental treatment of a radiolabeled antibody. The local toxicity doesn't seem to be an issue.

Of those that stand up patients for you can say for frontline treatment, but I know talks in my that would be about 70% of the 800, which will take it 160 and then as we also have started seeing they're using it in combination chemotherapy, sometimes and second line. So I think they are pretty much.

Klaus: So I think it's probably not going to be the case that they will replace a compartmental user from Burn-Map. And like anything else, I mean, that's one of the big challenges I've had to learn through my 35 years in the pharmaceutical industry. You always come up with something that's smarter than what you already have and that may not even have reached the market yet, and if you don't continue developing and getting the product that you're already working on finished, get it to the market, and start selling it, you're bankrupt before the much better version ever comes anywhere. So, you know as well as I do that although the SATA constructs may come into patients already next year, if So, I think. As enthusiastic as I can be about these constructs, it would never make me abandon any of the stuff that we're working on already, that is in patients, that is in clinics, that is close to BLA filings or already BLA filed. That is the future, and it takes time to reach the future.

Exposing diner Chuck's I'm apt to all patients <unk>.

And even starting to use it in some second line settings in combination, but chemo also.

So I mean.

In terms of.

What they could do I mean, I have no clue, what this strategy from United subjects will be I think what's important to us is that we want to keep the best treatment of these patients to help them best possible with the least side effects.

And again as I've said before and you have to pick and choose between.

Dozing off anybody that typically takes even 10 to 20 hours on the Monday infusion of diner talks a lot in combination with all true when G.M.C.S.. If we're supposed to 30 minutes confusion and then outpatient setting.

Let's call it that the kids have same amount.

Pain level, but all kids have the pain. They will 30 minutes and then it's up to map kids has a <unk>, which means that based on the data we have from doctor more it seems that'd be can reduce the need for for pain medication morphine with about 75 to 80 per cent during it causes surajit <unk>.

David Matthew Nierengarten: Thank you for answering my questions.

David Matthew Nierengarten: Cheers.

Boris Peeker: Our next question comes from Boris Peeker on Cohen. Please go ahead.

Boris Peeker: Good morning. First, I just want to know from the market perspective, what fraction of pediatric neuroblastoma patients are treated with Unituxin, and how do you see your message being kind of what competitive marketing could Unituxin manufacturers do as you get things intramural.

I mean.

I, it's hard for me to see how you would ask you to utilize a diner talks about in the second by and setting.

<unk> those constraints.

Klaus: Well, I mean, if you take the sales numbers, it looks like they're giving about 600 almost full patient treatments per year, and per year in the U.S., there are about 800 patients diagnosed with high-risk neuroblastoma in the U.S. Of those that are standard patients, you can say for frontline treatment with dinotoximab, that would be about 70% of the 800, which would take you to 560.

When next cinema as a naked Angie Buddy is exceeding the response rate that has been seen with buying a chops him up and second line in combination with two types of chemotherapy reading and she can seem a solemn I. It's just there must be 90, Buddy and it's much safer for the patients and it's just a much easier for the hospitals to handle.

And it saves hospitalization time, so for the parents also it's a huge benefit to be able to bring a kid home <unk>.

Klaus: And then, as we also have started seeing, they're using it in combination with chemotherapy, sometimes in the second line. So I think they are pretty much...exposing dinitroxamab to all patients with noblistoma and even starting to use it in some second-line settings in combination with chemo also. So, I mean, in terms of what they could do, I have no clue what the strategy from United Therapeutics will be. I think what's important to us is that we want to give the best treatment to these patients to help them as best we can with the least side effects. And again, as I've said before, if you have to pick and choose between a dosing of antibody that typically takes even 10 to 20 hours on the Monday infusion of dinotoxinab in combination with IL-2 and GMT-SF versus a 30-minute infusion in an outpatient setting, let's call it that the kids have the same amount of pain level, but our kids have that pain level for 30 minutes, and the I-I-I-I-I-I-I-I mean...

Bet his own bad at home and then come back to the hospital on Wednesday, rather than staying in the intensive care units in the hospital.

I think.

In front line time will show, how we will be able to penetrate and when the F.D. potentially could improve next to them up in front line, but I'd say outlined a little early we are definitely having at least ready to watch.

Front line potential supplements, Harry P.L.A. approval from the F.D.A.

Did that.

Yeah, Yeah. That's definitely helpful. Yeah, just to follow up on the front line, what's the status of discussion with the F.D.A.

The status of the discussion is that we are not discussing with yesterday onto that they have approved the product and second line.

So as I said, we we we have to study singles into studies ongoing starting I moved to send to study and the next six months and and then the plan is to go through the F.D.A. as soon as they have approved next to them up in second line and say Hey, you hear other data from O. two sinks into studies if the design of home. We'll just send the study this is where it's going to spend on Buffy.

Buttons, we have planned.

Klaus: It's hard for me to see how you would argue to utilize a dynatoxin map in the second mind setting with those constraints. When naxetamib as a naked antibody exceeds the response rate that has been seen with inotoximab and second line in combination with two types of chemotherapy, renal t-canine and fenosolamide, it's just a much better antibody, and it's much safer for the patients, and it's just much easier for the hospital to handle, and it saves hospitalization time. So for parents also, it's a huge benefit to be able to bring a kid home and have him or her sleep in her own bed or his own bed at home and then come back to the hospital on Wednesday rather than staying in the intensive care unit in the hospital. So I think. In frontline, time will show how we will be able to penetrate and when the FDA could potentially approve Nexidermab in frontline, but as I outlined a little earlier, we are definitely having a clear strategy towards frontline potential supplementary BLA approval from the FDA. Did that answer your question, Bo?

Propose to it meant this anyway and what is needed for supplements or do you like but that discussion go take with the F.D.N. as I said the earliest I could imagine would be first quarter next year.

Great. Thank you very much for taking my questions.

Sure thank the participating boards.

Our next question comes from the pound around that with J.P. Morgan. Please go ahead.

Hey, guys. This is passed on the call. This morning.

I'm glad to hear your out in long island. Thank you for keeping our question so what on on T.I.P.G.M.B.S.R.C.P.

This is like a catering to might be here for data Wow can we expect to see additional data this year and I mean more broadly how are you thinking about scope of data you want me could potentially file in Dallas indications, especially in the context in the high and that he thinks that much.

Sure, let's start out with the D.I.P.G. I mean again I don't know for sure. If we will be able to present additional data we had a presentation that ASKO last year and since then we have <unk> additional patients coming into the same person to study at M.S.K. I think the key thing again for T.I.P.T. is that we started multi send a protocol and that as I said.

Boris Peeker: Yeah, yeah, that's definitely helpful. Again, just to follow up on the front line: What's the status of the discussion with the FDA on this? Got it.

Presentation.

As planned to happen second half of this year again, taking into consideration all the thresholds of initiating new protocols in this environment, but but it's definitely oh objective to stop treating patients and then moved to send the P.L.P.D. study later this year and again the straight as he would be the same when as for frontline Nova Stoma.

Klaus: The status of the discussions is that we are not discussing with the FDA until they have approved the product in second line. So, as I said, we have two studies, single-center studies ongoing. We are starting a multi-center study in the next six months, and then the plan is to go to the FDA as soon as they approve it, and I set them up on the second line and say, hey, look, here are the data from our two single-center studies, here's the design of our multi-center study, this is where it's ongoing, this is the number of patients we have planned. Would you propose to amend this anyway, and But that discussion we'll have with the FDA, and as I said, the earliest I could imagine would be the first quarter next year.

When the F.D. has approved and burn them up.

For C.N.S., let somebody go metastasis from Nova Stoma, I'm Gonna take the data from the single sent this study at M.S.K.

And the protocol for the move to send to study and whatever I have updated from that and go to the F.D.A. and say Hey look.

These patients they have media in all survival up eight months, they have 10% to your survival probability and zero percent survival probability look here. We have 40, some patients treated with <unk>, we have a number of patients and have exceeded those three four and five years of survival and you can see that's in spite of the fact this being a dose escalate.

Boris Peeker: Great. Thank you very much for taking part. Sure. Thanks.

Boris Peeker: Sure. Thanks for participating, George.

Anupam Rama: Our next question comes from Anupam Rama with J.P. Morgan. Please go ahead. Hey, guys. This is Tess on the call this morning for ONU.com. Glad to hear you're all doing well, and thank you for taking our question.

So do you can see a clear trying to watch <unk> in higher dose levels in particular and patients that have not too extensive besides up the trauma what would be needed for getting supplementing it'd be really and I think such a meeting could take place in the first topic next year after that could come out and guide and say, Hey, <unk> <unk> <unk> <unk>.

Anupam Rama: So, what about DIPG and DSRCT? Can you just remind us of what the cadence might be here for data flow? Can we expect to see additional data this year? And maybe more broadly, how are you thinking about the scope of data you will need to potentially compile in both indications, especially in the context of the high unmet needs?

He used to do this meant expected to take this amount of time before we would be ready for supplementaries dealing.

And all the data will be out there so potential use.

Of the product endorsing vacations will definitely be there for the dog that may want to do with it.

Klaus: Thanks so much.

Klaus: Sure. Let's start out with the DIPD. I mean, again, I don't know for sure if we'll be able to present additional data. We had a presentation at ASCO last year, and since then, we have had additional patients coming into the single-center study at MSK. I think the key thing again for DIPD is that we start a multi-center protocol, and that, as I said in my presentation earlier, is planned to happen in the second half of this year. Again, taking into consideration all the thresholds of initiating new protocols in this environment, but it's definitely our objective to start treating patients in a multi-center DIPD study later this year. And again, the strategy would be the same as for frontline or vestoma.

You down so the question.

That's great Oh, that'd be a sample costs yep.

See we are going to have a similar approach of course and they are we have data from <unk>, that's even more rare that sounds really as the that as as it as 150 patients a year in the U.S.. We they have data from a study with about 50 patients and we just started a phase to study. So so again, we'll go and have a similar type of discussions with the agency at that time point.

Okay, great. Thanks.

Question. Thank you.

Our next question comes from Peter Lawson with Barclays. Please call ahead.

Hi, Thanks for taking the questions just stuff telling on the G.D. two expression question.

Where do you think take the.

But specific antibody.

And the data that we could see in October for the by specific what what could we potentially c.

[laughter], if I knew what you could see I would probably say it [laughter]. So I haven't seen the data but of course, we will be presenting safety data on the bike began to Buddy Guy up and hopefully you will also be able to percent or whatever you have to screen in terms of up a potential anti too much activity.

Klaus: When the FDA has approved embryo-to-mouth... for CNS leptomeningo-metastasis from noble stoma, I'm gonna take the data from the single center study at MSK and the protocol for the multi-center study and whatever I have of data from that and go to the FDA and say, hey, look, these patients have a median overall survival of 8 months. They have a 10% 2-year survival probability and 0% 5-year survival probability. Look here; we have 40-some patients treated with MSK. We have a number of patients that have exceeded both 3, 4 and 5 years of survival, and you can see that in spite of the fact this being a dose escalation study, you can see a clear trend towards better efficacy at higher dose levels, in particular in patients that do not have a too extensive size of the tumor. What would be needed for getting a supplementary BLA?

And but but right now it's too ready for me to say, what you could expect to be since I haven't seen any data. It's it's still in the database. So so that's no.

The available, though since the submitted abstract which was the same that was submitted to a. and all that was canceled.

<unk>, we've got enough time to them country see response rates right.

Well I mean.

I would definitely hope that we can see some responses in these patients and also I mean, especially since we are now at a dose level.

I would expect that dole's to be high enough to actually when you you wouldn't be able to introduce some technical activity.

Klaus: And I think such a meeting could take place in the first half of next year. After that, we could come out and guide them and say, hey, we talked to the FDA. The strategy is to do this. We'd be expected to take this amount of time before we're ready for supplementary BLA. And all the data will be out there. So potential use of the product in those indications will definitely be there for doctors that may want to do that.

But again it as I said I haven't seen any clear data a garden any direct information I stay away from that as long as we don't have data said, otherwise thinks gets a little bit too complicated, but the plan is still that'd be.

Based on Oh, and all this up expression of two did show will continue interface to study in Oklahoma sideline.

Patients that osteosarcoma progressing patient not the wants to be treated with next it I mean, so patients that are any d., but patients with progressing unless there was a coma and then we would start a separate moved to send to study in small so lung cancer also potential and he stopped end up this year.

Anupam Rama: That's great. Thank you for answering my question.

Klaus: Yeah, we at the Therapeutic Team are going to have a similar approach, of course. And there we have data from an even rarer condition, that's as rare as 150 patients a year in the U.S. We have data from a study with about 50 patients, and we just started a Phase II study. So again, we'll go and have a similar type of discussion with the agency at that time point.

So those are the three and then just yeah.

Sorry, an interest does telling on the kind of number of centers you could potentially target when you.

Commercial could you talk to that build up a number of.

Anupam Rama: Okay, great. Thank you for taking our questions. Thank you. Sure.

Sales people have to think it though.

Peter Lawson: Thank you.

M.S.G.N.A. mm mm.

Peter Lawson: Our next question comes from Peter Lawson with Barclays. Please go ahead. Hi, thanks for taking my questions. Just dovetailing on the duty to express question, where do you think you'd take the... The bi-specific antibody and the data that we could see in October for the bi-specific, what could we potentially see?

Yeah, I mean, but we have to another said that we have you have looked into where did dying to talk some about everyone gets old which send us an actually ordered diner trucks map and and we came up with about 200 different hospital pharmacies that had ordered <unk> throughout the United States. We also found out that more than.

Peter Lawson: If I knew what you could see, I would publish it, so I haven't seen the data, but of course, we will be presenting safety data on the bi-specific antibody at SCIOP, and hopefully, we will also be able to present whatever we have seen in terms of potential anti-tumor activity. But right now, it's too early for me to say what you could expect since I haven't seen any data. It's still in the database. So, there's no poster available; that was just a submitted abstract, which was the same that was submitted to A&R but was cancelled.

80% of all the files set that were sold had thought <unk> been going to 80 sites and actually 50 sides to Tibet, Georgia, the 80%. So it's pretty clear to us that we need to focus on these 50 to 80 sites.

And then you can make your own calculation, but I think at good gas would be that'd be we'll have about 10 sales people out there.

In addition to the medical science lessons.

So so we we have a relatively you can say.

Klaus: Well, I mean... I would definitely hope that we can see some responses in these patients and, especially since we are now at a dose level where I would expect the dose to be high enough to actually be able to induce some clinical activity. But again, as I said, I haven't seen any clear data or gotten any direct information. I stay away from that as long as we don't have a data set; otherwise, things get a little bit too complicated.

Decent size customer group and when he comes to <unk>, it's even less because that also takes to decide has every two pharmacy that can actually handle that way too late with anybody I think on but I will be used that less than 20 sites in the U.S. Initially then I said start spreading out to T.I.P.D.N.D. is is that.

T and other indications, you'll see spreading out to more hospitals.

Klaus: But the plan is still that we, based on our knowledge of expression of GG2, will continue in a Phase II study in neuroblastoma, the SIRT line, patients that are osteosarcoma-progressing patients, not the ones that we treat with maxitumab. These are patients that are NED but patients with progressing osteosarcoma. And then we would start a separate multi-center study in small-told lung cancer also with a potential IND start end of this year.

Did that also the question <unk>, yes, perfect. Thanks to take my questions.

Oh cool.

Hi next question comes from David Nearing grandson with Bush Securities. Please go ahead.

Hey, Thanks for taking a class and just too quick ones first on <unk>, the T.C.M. or do you keep your.

Refers virus going on Ernie updated time lines on opening sites and and getting during patients recruited to that and then the second one on the say to technology.

Klaus: So those are the three.

Peter Lawson: Those are the three entities we have planned.

Klaus: Sorry and then just dovetailing on the kind of number of centers you could potentially target when you Get Commercial. Could you talk to that, build out a number of... That sounds, people, like how we should think about SG&A.

It would seem from the dynamics expert present or that the.

Uh-huh amount of radio isotope toast might might be higher and and we do a higher costs of goods is that a fair assumption I know, it's early but I'm just curious when you think about.

Klaus: Yes, I mean, what we have done is that we looked into where Dinatoximab ever got sold, which centers actually ordered it, and we came up with about 200 different hospital pharmacies that had ordered it throughout the United States. We also found out that more than 80% of all the vials that were sold had been going to 80 sites, and actually, 50 sites took the vast majority of the 80%. So it's pretty clear to us that we need to focus on these 50 to 80 sites.

Your relatives <unk>. Thanks.

Right. So in terms of <unk> them 177 that construct I would guess that'd be a ready to recruit patients next quarter.

For the.

Put the middle of customer studied a pediatric one and the Arrow protocol will follow shortly after that maybe fourth quarter, it will stop including patients.

Klaus: And then you can make your own calculation, but I think a good guess would be that we will have about 10 salespeople out there in addition to the medical science layers. So we have a relatively, you can say, decent-sized customer group, and when it comes to Onbertumab, it's even less because that also takes into account that the site has a radiopharmacy that can actually handle the radiolabeled antibody. I think Onbertumab will be used at less than 20 sites in the U.S. initially. Then, as it starts spreading out to DIPD and DSSRT and other indications, you'll see it spreading out to more hospitals. Get that out of the way.

So so but again opening the size doing initiation visits maybe pushing things a little bit, but but I don't foresee any significant delays there in terms of solder and the dosing.

I'm, a little bit uncertain, where we will end up the great thing here is that.

You know the radiation, even if I inject 100, millicurie of radioactive blue cheese show him that his cage in the daughter molecule.

You could easily tolerate that because it's just going into the bloodstream and the only state place it will accumulate that's where the.

Peter Lawson: Did that answer the question? Thank you very much. Yes, perfect. Thanks for taking the time to answer the questions.

Take some Eric antibody has bound on the two more because that's where the by specific part that expresses the T.D. two binding site is sitting so when daughter pauses, it's gonna be <unk> by the door to bind part of the antibody into too much going to accumulate a lot of radiation.

David Matthew Nierengarten: Thank you. Our next question comes from David Nierengarten with Wetbush Securities. Please go ahead.

David Matthew Nierengarten: Hey, thanks for taking the question. Just two quick ones.

All the <unk> that doesn't get graft and passes by the kidneys is gonna be excrete it.

David Matthew Nierengarten: First, on Umbrotamab, Lutetium, or DTBA. With the virus going on, are there any updated timelines on opening sites and getting patients recruited for that? And then, on the state of technology, it would seem from the dynamics that you presented that the amount of radioisotope dose might be higher and lead to a higher cost of goods. Is that a fair assumption? I know it's early, but I'm just curious when you think about, you know, relative isotope dosing in there. Thanks.

So it's quickie out of the Buddy again, and I could potentially given other dose the following week.

And another dose the following week in an overdose the following week.

So normally we are limited when giving raid you isotope because the Rachel isotope stays too long time in the body.

And it doesn't get the point since if you give well I think it's a good example could be there the little to Sarah product, which is a 25 amino acid peptide that has a daughter finding that also.

Klaus: Great. So in terms of ompetamide, lutetium-177, that construct, I would guess that we are ready to recruit patients next quarter. For the medulloblastoma study, the pediatric one, and the adult protocol will follow shortly after that. Maybe in the fourth quarter, it will start including patients. So, but again, opening the sites during initiation visits may be pushing things a little bit, but I don't foresee any significant delays there, in terms of SATA and dosing. I'm a little bit uncertain about where we will end up.

<unk>.

But the whole construct is being injected at the same time and therefore, because it's much <unk> it stays longer time in circulation and therefore, there's you can say at the door level of how much you can actually get into the patient and bind to the new rain declined <unk>.

So so I hope that made sense, it's a little bit long haired discussion about.

Yeah <unk>.

Klaus: The great thing here is that even if I inject 100 milligrams of radioactive lutetium that is caged in the DOTA molecule, you could easily tolerate that because it's just going into the bloodstream and the only place it will accumulate is where the, Thanks for watching. All the lutetium that doesn't get grabbed and passes by the kidneys is going to be excreted, so it's quickly out of the body again, and I could potentially give another dose the following week. And another dose the following week, and another dose the following week. So normally, we are limited when giving radioisotopes because the radioisotope stays too long in the body. And it doesn't get...for instance, if you give...I think a good example could be the Lutasera product, which is a 25-amino acid peptide that has a DOTA binding that also caries radioactive lutetium, but the whole construct is being injected at the same time, and therefore, because it's a much larger molecule, it stays in circulation for a longer time, and It's a little bit of a long-haired discussion about these things.

Yeah.

Our next question comes from <unk> Janumet Comrie, Scott Please call that.

Hi, I think if your questions.

First one is <unk> I believe you already have a good number position was C.N.S. met medicines from other type of humor treat it was 131, <unk>, just one or or those data going to be included in but the always condition and I believe you said that <unk>.

The adult basket approach and and no doubt the other concept too much shorter time to label, but in terms of <unk> do you expect improvement when you switch to different labeling.

It's right that we have I think almost 30 patients add all patients that have been exposed to them, but I mean once already one the safety data from these patients is a part of the P.L.A. filing, but we have not included any figures the data from these places because it's gonna again.

The strip the discussion, but anybody that has been exposed to the on button them up ready to labeled antibody isn't the safety data packets of them, but I'm not fighting.

David Matthew Nierengarten: ...

David Matthew Nierengarten: Thank you.

David Matthew Nierengarten: I appreciate it. Yeah.

In in terms of.

Yoon Jung: Our next question comes from Yoon Jung with Jenny Montgomery Scott. Please go ahead. Hi, thank you for taking the questions. So the first one is on BIRTMAP. I believe you already have a good number of patients with CNS metastases from other types of tumors treated with 131 labeled on BIRTMAP. Just wondered, are those data going to be included in the DLA submission? And I believe you said that we'll support the adult basket approach, and I know that the other construct takes a much shorter time to label, but in terms of efficacy and safety, do you expect improvement when you switch to a different labeling?

Safety I don't think we will see any major difference between the low teach them 177, and the already in 131, both of them emits what's called beat a radiation and it's in both cases electrons and the energy and the electrons from the new T. shirts, a molecule is about 80 280.

85% of the energy you have to electrons being thrown off the I.D. in 131. So you can say that the penetration off an electron from teach maybe like 15% shorter than dependent training up the electrons from the from the I already but but that's the difference. So that's also why in the adult.

Yoon Jung: It's right that we have, I think, almost 30 patients, adult patients, that have been exposed to ombudamap iodine-131. The safety data from these patients is a part of the BLA filing, but we have not included any efficacy data from these patients because it's going to, again, disrupt the discussion. But anybody that has been exposed to the ombudamap regulatory antibody is in the safety package of the ombudamap filing.

Basket trial, we're starting with the <unk> teach them construct.

Yeah, including a eight.

Dose escalation part of the study to see if we in the adults.

Can doze off to maybe 70, 80, maybe 100 million Curry they'll teach them can stop from the C.N.N. So so there'll be a an investigation into that also in the basket trial.

Did that answering your question.

Yes, it does and so the second question I know that it's <unk>.

Klaus: In terms of safety, I don't think we will see any major difference between the lutetium-177 and the iodine-131. Both of them emit what's called beta radiation, and it's in both cases electrons. And the energy in the electrons from the lutetium molecule is about 80 to 85% of the energy of the electrons being thrown off the iodine-131. So you can say that the penetration of an electron from lutetium may be about 15% shorter than the penetration of the electrons from iodine. But that's not what I meant.

I know that's your talk though that the filing will not be possible until probably towards the end of 2021.

Able to get any details regarding what will be dumb for you to get the the tip <unk>.

Well I mean, we we are planning a discussion with email on the <unk>.

So that should take place in the next three months when we have an agreement on the paper with email will definitely disclose it and I expect that you will be starting the necessary study for the European filing probably in the next three to six months again, considering coby, then everything but but.

Yoon Jung: And that's also why in the adult basket trial, we are starting with the Onbertumab DTPA lutetium construct. We are including a DTPA dose escalation part of the study to see if we can dose up to maybe 70, 80, maybe 100 milligrams of lutetium construct in the CNS. So there will also be an investigation into that in the basket trial. Did that answer your question, Yun?

But we do we do need to treat some additional patients in a combination with chemotherapy and an extra them up for the European fun.

[noise] great. Thank you very much.

Information will get closer absolutely.

Right next question comes from our Lyndon leave with Ken. According you already please go ahead.

Yoon Jung: Yes, it does. And so the second question, I know that it's on Nexidimab in the EU. I know that you talked about that the filing will not be possible until probably towards the end of 2021. Are you able to give any details regarding what will need to be done for you to get the PIP, P-I-P?

Yeah Linda.

I I think you're taking my question I had a couple of them and devices that they can provide you guys were supposed to presented an hour. It was curious about yes, I guess at the end of last year, you had talked about having six patients enrolled I'm I'm wondering what the scope of what.

Klaus: Well, I mean, we are planning a discussion with EMA on the PIP, so that should take place in the next three months. When we reach an agreement on the PIP with EMA, we will definitely disclose it. And I expect that we will be starting the necessary study for the European filing probably in the next three to six months, again, considering COVID and everything. But we do need to treat some additional patients in combination with chemotherapy and eczema for the European filing.

Might see later this year might look like and if there's a particular medical meeting you've targeted and then on the G.D.P.G.D. three vaccine you've talked about extending that patient or sorry that trial.

Yes, whether that requires another I.N.D. or any other getting factors like that and maybe.

Yoon Jung: Great. Thank you very much. Keep the information coming, and we will get closer. Absolutely.

And then sorry back to the specific if let your plans are on expanding that trial and <unk> additional education. Thank you.

Erlinda Lee: Keep in touch, and we will get closer. Absolutely.

Erlinda Lee: Our next question comes from Erlinda Lee with Canaccord Genuity. Please go ahead.

Erlinda Lee: Thank you.

Yeah sure on on the by specific right. We had about I think six or seven patients at that the end of last year <unk>. We I mean, the only thing I can say is are we planning to present the desire in October.

Erlinda Lee: Hi guys, thanks for taking my questions. I had a couple of them.

Erlinda Lee: On the bispecific antibody that you guys were supposed to present at ANR, I was curious about if, I guess, at the end of last year, you had talked about having six patients enrolled. I'm wondering what the scope of what we might see later this year might look like and if there's a particular medical meeting you've targeted. And then on the GD2, GD3 vaccine, you've talked about expanding that patient population or, sorry, that trial. I'm curious whether that requires another IND or any other gating factors like that. And then, sorry, back to the specifics, what your plans are for expanding that trial into additional indications. Thank you.

No 'cause then whenever we haven't that time and honestly I don't know I haven't gotten any specific photo, but we are still planning to move on with the with the three phase two studies.

Short line up a storm or us there was a coma patients progressing and also lung cancer.

In terms of the <unk> to G.D. tree.

Correct, we will be filing a separate.

And the for then we'll just send to study outside of the M.S.K. investigator I.M.D.

And we are still planning to do that in the second half of this year.

Klaus: Yeah, sure. On the bi-specific, you had about six or seven patients at the end of last year. I mean, the only thing I can say is that we're planning to present at SIRB in October. And we'll present whatever we have at that time, and honestly, I don't know. I haven't... gotten any specific follow-up on that. We are still planning to move on with the three phase two studies: Shirtline Oblastoma, Osteosarcoma Patients Progressing, and Small Cell Lung Cancer.

So so we frantically collecting data to put together investigative brochures and all kinds of stuff to get the protocol and everything ready for the <unk> vaccine study in.

Second permission patients.

[noise], Okay, and then on on the bike 50 states.

The feature initiations eating nothing happened here or is it more and next year event Yep.

Klaus: In terms of the vaccine DD2, DD3, correct, we will be filing a separate IND for the multicellular study outside of the MSK investigator IND. And we are still planning to do that in the second half of this year. So we're frantically collecting data to put together investigator brochures and all kinds of stuff to get the protocol and everything ready for the IND, for the multi-center vaccine study in sick and remission patients.

Yes, this year for definitely for the <unk> studies, continuing deep phase Funchal protocol, they're small so lung cancer will you finished this year the protocol and 95 I don't think you'll see patients recruitment in small so lung cancer, starting awesome first quarter next year.

Okay [noise].

Thank you very nice.

Erlinda Lee: Okay, and then on the bi-specific... The Phase 2 initiations, do you think that's going to happen this year, or is it more of a next year event?

[noise] [noise]. It's concludes the question and answer session I would like to train the conference back over that time this cat for any closing remarks.

Klaus: Yes. This year, definitely for Novostoma and Osteosarcoma, which are legacy studies continuing the Phase I-II protocol, small cell lung cancer will be finished this year. The protocol and IND filing, I don't think we'll see patient recruitment for small cell lung cancer starting in the first quarter next year.

Yeah, well. Thank you everyone and thank you for your questions and being available today and hopefully we'll all these <unk> Oh. This soon and maybe we want to stay well.

Thanks.

[noise]. This concludes today's conference call you made disconnect Caroline Thank you for participating and have a pleasant thing.

Erlinda Lee: Okay.

Thomas Gad: Okay. Thank you very much. This concludes the question and answer session. I would like to turn the conference back over to Thomas Gad for any closing remarks.

Mm.

Operator: Yeah, well, thank you everyone and thank you for your questions and being available today, and hopefully, we'll all be out there soon, and everyone stay well. Thanks.

Mm mm.

Mm.

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Yeah.

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Yeah.

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Mmm.

Mm.

Operator: This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.

Mm.