Q2 2020 Y-mAbs Therapeutics, Inc Earnings Call

Good morning, and welcome to the why that Therapeutics Inc. second quarter 2020 earnings Conference call.

Operator: Good morning and welcome to the Y-mAb Therapeutics, Inc. second quarter 2020 earnings conference call. Today's conference is being recorded. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined by the Private Securities Litigation Reform Act of 1995.

Today's conference is being recorded.

Let me quickly remind you that the following discussion contains certain statements that are considered forward looking statements.

As defined by the private Securities Litigation Reform Act of 1995.

Operator: Because forward-looking statements involve risks and uncertainty, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those factors discussed in the company's annual report on Form 10-K for the fiscal year ended December 31, 2019, as well as with the SEC on March 12th, 2020. And in the company.

Because forward looking statements involve risks and uncertainties. They are not guarantees of future performance and actual results may differ materially.

From those expressed or implied by these forward looking statements.

Variety of factors, including those factors discussed in the Companys annual report on form 10-K for the fiscal year ended December 31st 2019.

With the FCC on March 12, 2020.

Companies.

Operator: All officially filed SEC reports. At this time, I would like to turn the conference over to Mr. Thomas Gad, the company's founder, chairman, and president. Please go ahead, sir.

Actually filed says he see reports.

At this time I would like to turn the conference over to Mr., Thomas God, The company's founder Chairman and President.

Please go ahead Sir.

Thank you Donna Thank you everyone and good morning, Thanks for joining us today, Oh, I go too loud and clear no. We had this storm the lines off and running.

Thomas Gad: Thank you, Donna. Thank you, everyone, and good morning, and thanks for joining us today. I hope I come through loud and clear, even though we had a storm.

Thomas Gad: I hope the lines are up and running. So, despite COVID-19, the second quarter of 2020 has been very strong for Y-mAbs. We believe we've made significant progress in executing our strategy and taking steps that will position us very well for the potential product launches of our two lead product candidates, Nacitamate and Umbertamate. As you know, we completed the submission of the Nacifimab BLA in March and received the PDUFA date in November this year. And in addition, the submission of the Embryosimab BLA to the FDA was completed earlier this week. We ended the second quarter with approximately $158 million in cash. So we believe we have a strong balance sheet to support the potential launch of both nacizumab and umbertumab while at the same time achieving our development pipeline. We believe that our cash decision should carry us through the end of 2022 without taking into consideration any product sales or potential partnership income.

So despite the covert 19, the second quarter off 2020 has been very strong for why much. We believe we made a significant progress on executing all strategy.

And taken steps that will position us very well for the potential product launches are about to lead product can do that.

Sure Tonight or tomorrow.

That's you know we've completed submission up then it should not be other in March and received a producer like November this year and in addition, the submission to the unfortunate be allowed to do you have gave was completed earlier this week.

We ended the second quarter was approximately 158 million in cash so we believe.

We have a strong balance sheet to support the potential launch at both shifting about an unfortunate.

Well at the same time, achieving all development pipeline.

We believe that all cash position should carry us through the end up 2022 without taking into consideration any product sales or potential partnership income.

Thomas Gad: We are very pleased with our financial position, which Bo will talk about later on this call. As a company, we always work very hard to stay true to our position as a leader in pediatric oncology, addressing clear, unmet medical needs and focusing on advancing our therapies to improve the lives of children living with these rare cancers. Concurrently, we're starting to see our pipeline and technology platform widely reach into adult patient populations, where the lutetium labeled on Burk's map will soon be tested in adult B7H3-positive cancers and the DD2-Bi-specific, scheduled to enter Phase II in small cell lung cancer later this year. We're also very excited about our new licensing agreement with MSK and MIT, which we entered into in April to expand our antibody platform with the SADA technology. We believe SATA technology represents a new approach to pre-targeted radioimmunotherapy, which we refer to as liquid radiation. And SADA may have potential to improve the current treatment landscape in oncology since it appears to enhance the therapeutic index of payload delivery. We believe Sarah

We were pleased with all financial position, which bill will talk about laid on this call.

As a company, we always worked very hard to stay true to arbitration obsolete pediatric oncology attrition clear unmet medical need.

And focusing on advancing all therapies to reach the lives of children living with these rare cancers.

Currently.

Starting to see our pipeline that technology platform why this reach into adult patient populations with location labels on person that well shouldn't be tested.

I don't be seven eight street positive cancers, and the GE to five specific.

Scheduled to enter phase two in small cell lung cancer later this year.

We also very excited about all new licensing agreement with M.S.K. and I might cheap, which we entered into an April to expand all antibody platform, but the satellite technology.

We believe Sato technology represents a new opposed to pre targeted radio immunotherapy.

Which we refer to as liquid radiation.

I'm, sorry, I may have potential to improve the current treatment landscape in oncology since disappear since its it appears wouldn't have to therapeutic index of payload deliberate.

We believe SATA technology appears to be very promising it may be able to check <unk> radio conjugated antibody constructs to a new level after trends really open up for a much broader usage and any other radial they'd like technology and do you have somebody area.

Thomas Gad: Thank you. We expect to deploy the SARA technology in a range of adult tumors as well as in pediatric. And our targets include HER2 for breast cancer, B7H3 for prostate cancer, and TPA33 for colon cancer, thereby adding further exposure for the company in adult patient populations. I'm also very happy to announce that Laura Hamlin has joined our Board of Directors. Laura has extensive experience in the industry, with over 30 years of global commercial experience and a rarity of executive leadership positions, most recently as Executive Vice President at Gilead. Laura adds significant commercial expertise to our board, which will be of great value to our plans for commercial organization and bring our product candidates to patients. Today, as always, you will hear remarks from Dr. Klaus Moeller, our CEO, and Bo Kruse, our Chief Financial Officer. And I will hand it over to Klaus now. Thank you.

We expect you deployed to solve technology in a range of adults you must as well as pediatrics.

And I'll talk to her chiu for breast cancer, B, seven athree prostate cancer and T. P 833 colon cancer.

Thereby adding further exposure for the company in adult patient population.

I'm also very happy to announce that lower Hamilton has joined our board of directors.

Lora has extensive experience in the industry with over 30 years of global commercial experience in a rarity of executive leadership position.

As recently as executive Vice President Galleria.

Laura at significant commercial expertise to up or which would be afraid value.

Well plants for commercial organization and bring all product candidates to patients.

Today, It's always you will have remodulin.

<unk>, while she Oh and both of these all Chief Financial Officer, and I'll hand, It Oaks class no. Thank you.

Thank you Thomas and welcome again to I'm upset periodic second quarter 2020 earnings call.

Klaus Moeller: Thank you, Thomas, and welcome again to Y-mAbs Therapeutics' second quarter 2020 earnings call. We are very pleased that you have chosen to spend this morning with us.

We're very pleased to do you have chosen to spend this money with us or let me start by saying that we continue to closely monitored the impact of Koby 19 also on our business. We have implemented a number of measures to protect the health and safety up all the employees.

Klaus Moeller: 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 mitigate potential disruption to our supply chain and continue our clinical trials and planning of commercial activities. While we have seen some near-term impact on clinical trial site initiation and patient enrollment, we have not changed our guidance for key anticipated 2020 clinical data readouts. To date, we are pleased with the continuity of our business and our ability to support the critical needs of cancer patients in our ongoing trials. We will keep you updated as appropriate going forward.

Also taking steps to mitigate potential disruption to our supply chain and continue our clinical trials and planning of commercial activities.

Why we have seen some near term impact on clinical trial site initiation and patient enrollment we have not changed our guidance for key anticipated Twentytwenty clinical data read outs to date, we're pleased with the continued tee up all business and our ability to support the critical need of cancer patients and ongoing trial.

We will keep you updated as appropriate going forward during the second quarter. We have continued to work hard to ensure that out to lead product candidate next set them up in a bottom up and wants to watch the market.

Klaus Moeller: During the second quarter, we have continued to work hard to ensure that our two lead product candidates, Maxitamab and Ampertamab, advance towards the market. For Nexetamab, as you will recall, we completed the BLA for Nexetamab in March this year. And we have now received the PDUFA date, November 30th this year. I had a number of discussions with the agency and are still confident that we will be able to stick to this plan.

For next set of my Best you will recall, we completed the de lay Pfenex set them up in March this year and we have now received the PDUFA date of November Thirtyth. This year and I had a number of dialogues with the agency and that's still confident that people will be able to stick to this plan. The DNA is for treatment of patients.

Klaus Moeller: The BLA is for treatment of patients with relapsed refractory high-risk neuroblastoma in bone and bone marrow. The BLA submission is based on the safety and efficacy results of the pivotal studies called 201 and 12230, which we expect to present data from at a suitable venue later this year. In terms of post-marketing commitments, we are aiming for a two-year progression-free survival for the planned patients from study 201, in addition to the ones that were in the filing. In addition to the BLA for Nexetamab, we have trials ongoing in Barcelona and at MSK for first-line neuroblastoma, as well as chemocombination trials for refractory neuroblastoma patients. During the remainder of 2020, we expect to initiate an international phase 2 multicenter trial for nuxetamib in both frontline and with chemocombination treatment. Now, let me jump to Umberto Mapp, our lead researcher, our second lead compound.

That's refractory high risk no, but still not.

In bone and bone marrow the b. They submission is based on the safety and efficacy results up the pivotal studies coal to a one and talk to study, which we expect to present data problem at a suitable when you later this year in terms of post marketing commitments, we are aiming for a two year progression free survival for the planned patients from this.

Sure one and in addition to the ones that were out ended finally in addition to the DNA for next set them up we have trials I'm going in Barcelona, and that they missed skate for first line opus drama.

Wellness chemo combination trials 12, Refracturing opus still my patients during the remainder of Twentytwenty, we expect to initiate an international face true multicenter trial, when exit them up in those frontline and with chemo combination treatments.

Now, let me jump from bottom up our lead our second lead compound we had the pre DNA meeting with the F.D.A. in February this yet, but very pleased to have all plans confirmed by the agency for the be late we initiated the rolling delay in June and completed the DNA submission earlier this week for the treatment of patients.

Klaus Moeller: We had a pre-BLA meeting with the FDA in February this year, and we're very pleased to have our plans confirmed by the agency for the BLA. We initiated the rolling BLA in June and completed the BLA submission earlier this week for the treatment of patients with CNS leptomeningo-metastasis from norepistoma. This is a few weeks later than we had originally anticipated back in February after the pre-BLA meeting but before COVID-19 started to affect our activity.

CNS Letterman Ingo metastasis from the oldest stole my.

This is a few weeks later than we had originally anticipated back in February after the tree DNA meeting, but before the call. We'd 19 started to affect L. activities. However, we are very pleased to have the in house competence to work and coordinate the submissions up another be late filing only four months after the completion of to submit.

Klaus Moeller: However, we are very pleased to have the in-house competence to work and coordinate the submissions of another BLA filing only four months after the completion of the submission of the Nexidermab BLA, and we will continue to keep you posted on our progress. We are hoping to confirm a post-marketing commitment showing three-year overall survival from 32 patients in study 101 to be significantly better than a 10% overall survival reported historically. We will present preliminary data from the pivotal 101 study in CNS leptomeningal metastasis from noreblastoma at SIOP later this year, in October.

Enough that Nick said it might be a late and we will continue to keep you posted on our progress.

We are hoping to confirm opposed to markets and commitment showing three year old survival from 32 patients from the study one of one to be significantly better than a 10% overall survival report has historically.

We will present preliminary data from the pivotal one a one study in CNS lifts. So many of them metastasis from the oldest stoma at sign up later this year that's in October.

Klaus Moeller: In addition to the U.S. development program, we are making good progress in Europe, and we plan to submit a marketing authorization application for Ombertumab within the next six months. This is a vital step forward in our efforts to potentially bring Ombertumab to the market in Europe in 2021. As previously discussed, we are also developing Umbertumab for diffuse-intrinsic pontine glioma, known as DIPD, in a phase one study at MSK, and we are planning to open a multi-center phase two study for DIPD patients in 2020. For desmoplastic small round cell tumors, also known as DSSRCT, we have recently opened a Phase II study at MSK.

In addition to the U.S. development program, we're making good progress in Europe, and we plan to submit a marketing authorization application Trump bump into them up within the next six months. This is a vital step forward in a way for us to potentially they bring a button up to the market in Europe in 2021.

As previously discussed we also developing a bunch of my foot diffuse intrinsic content like home on it.

No one asked the I P. D interface, one study at M. escape and be a planning to open multi center phase two study for D.A.P.D. patients in Twentytwenty.

But there's more plastics more rumsfeld show must also known as yes. This assay tea. We have recently opened the phase two study at M.S.K.

Klaus Moeller: For our Lutetium-177-labeled Onbertumab DCPA construct, we are planning to open a multicenter Phase I-II study in pediatric medulloblastoma next month. And we also plan to open a second Phase I-II study, which will be a basket study for B7H3-positive CNS leptomeningo-metastasis in adult patients later this year. For both studies, we hope to utilize our prior experience of treating patients with these indications with iodinated 131 Iodine on Botimap.

Well I wanted to see showing 177 labeled a bunch of map TCPA constructs, we're planning to open a multi center phase one two study in pediatric Medulloblastoma next month and we also plan to open the second phase one two study, which will be a basket study could be seven eight street positive CNS, let somebody got metastasis in adult.

Patients later this year.

For both studies, we hope to utilize our prior experience of treating patients with these indications would the I had the needed.

Once or anyone ideas about him up I'm very pleased to see the second generation a bunch of map entering the clinic very soon.

Klaus Moeller: I'm very pleased to see the second generation of Botimap entering the clinic very soon. From a commercial standpoint, we believe that we are very much on track to build the right size, best-in-class commercial organization in time for the potential approvals of both Noxidimab and Embertimab. Should the potential Noxidimab approval even come before the PDUFA date, we will also be prepared for that. Given the small universe of pediatric cancer centers that treat the majority of neuroblastoma patients, we believe that we can build a lean and highly targeted commercial organization and launch both compounds ourselves. Our commercial team is largely in place. As many of you know, we hired our chief commercial officer, Phil Herman, more than two years ago, and we have been building his team ever since.

On the commercial standpoint, we believe that'd be a very much on track to build the Rightsized best in class commercial organization in time for the potential improvements oppose makes it a map and about a month.

Sure the potential next set them up approval even come before the PDUFA date, we will also be prepared for that.

Given the small universe of pediatric cancer centers that treat the majority often they're open to stole my patients. We believe that we can build and lead and highly targeted commercial organization and launch boasts compounds ourself.

Our commercial team is largely in place as many of you know we had our chief commercial officer fill Herman more than two years ago and we've been building his team ever since in addition, we have medical science license in the medical affairs groups in place. So we believe we are positioned very well for the potential launches next set them up and embed them up in the U.S.

Klaus Moeller: In addition, we have medical science licenses in the medical affairs groups in place. So we believe we are positioned very well for the potential launch of maxidermab and ambutamab in the U.S. market. Since the European marketing application for Amphetamide is potentially only about six months behind the U.S., we plan to begin staffing our European commercial operations towards the end of 2020. The SATA technology that Thomas also mentioned briefly was licensed

As market.

Since European marketing application from Photomask is potentially only about six months behind the U.S., we plan to begin staffing our European commercial operations to whats the end of Twentytwenty.

The SATA technology that Thomas also mentioned briefly I was licensed and in April It's an agreement with Memorial Sloan Kettering, Kansas, and then, Massachusetts Institute of Technology for worldwide exclusive license and research collaboration to develop the antibody construct based on the SATA molecule self assays.

Klaus Moeller: It's an agreement with Memorial Sloan Kettering Cancer Center and Massachusetts Institute of Technology for worldwide exclusive license and research collaboration to develop the antibody construct based on the SATA molecule, a radio immunotherapy platform. We also refer the SATA platform to as liquid radiation. The Starbuck platform operates in a two-step manner.

Good thing, it's the same thing anybody constructs, it's a major immunotherapy platform. We also refer the SATA platform through as liquid radiation.

This other platform operates in a two step manoj.

Klaus Moeller: In the first step, a saturating dose of tumor-targeted, unlabeled, bispecific antibody fragment is injected. These bispecific antibody fragments are self-assembled in vitro prior to their injection into tetramers, and they subsequently bind to tumor cells. After a few hours, excess tumor-targeted antibody constructs that have not bound to the targeted tumor cells disassemble due to the dilution in serum into smaller antibody fragments that are then subsequently excreted quickly through the kidneys. In the second step, the next day, when the concentration of antibody constructs not bound to the tumor is at its peak, bound to the tumor is at its peak and much higher than in normal organs, a radio-labeled compound that binds to the other end of the bispecific constructs, the DOTA binding part, is injected.

In the first step a saturating dose.

Tumor targeted unlabeled by specific antibody fragments is injected these by specific antibody fragments ourself assembled in vitro prior to the injection into Tetra Miss.

And subsequently bind to the tumor cells.

After a few hours access to more targeted antibody constructs that have not bound to the targeted to myself. This a sample due to that dilution in cerro into smaller antibody fragments that are then.

Subsequently excrete it quickly through the kidneys in the second step the next day when the concentration of anti body.

Constructs not bound to the too much is at its peak bouncer. The tumor is at its peak and much higher than a normal organs and radio label compound that binds to the other end up the bi specific constructs that dota binding pod isn't yet it.

Klaus Moeller: In published papers utilizing similar approaches, data indicate that this two-step process results in a much higher tumor-non-tumor concentration ratio, which we believe is favorable for radiotherapy since it substantially minimizes radiation damage to healthy tissue. We believe SATA potentially could improve the efficacy of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents, i.e. tumors with multiple macroscopic lesions larger than 3 or 4 centimeters in diameter, as it appears to subsequently allow a higher radioactivity level to be injected without impairing the hematological toxicity.

In published papers utilizing similar approaches data indicate that this two step process, resulting in a much higher too much non tumor concentration rate your which we believe is favorable for major therapy since its substantially minimized the radiation damage to the helps it tissues.

We believe SATA potentially could improve the fixed seeks afraid you a day, but therapeutics in tumors that have not historically demonstrated meaningful responses to regulate and agents I eat tumors with multiple macroscopic lesions larger than three or four cents, Jimmy dusting diameter as it appears to subsequent yellow higher.

They do activity level should be objective without impairing the hematology hematological toxicity.

Klaus Moeller: We have initiated the development of a number of SATA-based constructs created by MSK, including a DD2 SATA for DD2-positive solid tumors, a GPA33 SATA for potential use in colon cancer, and a HER2 SATA for potential use in breast cancer. We expect to advance a series of proprietary constructs as well. We were very pleased to designate the B7H3 SATA for potential use in prostate We plan to file the first IND within the next 12 months for a SATA construct and hope to start treating patients with this exciting technology shortly thereafter. We believe the SARTA 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 and also in larger adult indications. The platform is also available for sub-licensing, and we hope to see the SARTA technology make a significant contribution to improve the treatment landscape in radioimmunotherapy in the coming years. To support our growth plan, we have increased our headcount to a total of 89 employees during the second quarter of the year.

We have initiated development up enough Pops out of based constructs created by M.S.K., including a de de Toussaud up but you did show positive solid tumors.

<unk> trees out for potential using colon cancer I heard to set up a potential use in breast cancer and we expect to advance a series of proprietary constructs as well as we were very pleased to designate the b seven eight street you saw that potential use in prostate cancer as the first of these constructs a few weeks ago.

Plans to file the first I indeed within the next 12 months for SATA construct and hope to start treating patients with this exciting technology. Shortly thereafter, we.

We believe this out of technology platform makes tremendous sense for why maps and it could potentially allow us to under up even further potential into field of radio labeled antibody.

Those for specialty oncology indications and also in larger adult indications. The platform is also available for Sublicensing and we hope to see this out of technology and make significant contribution to improve the treatment landscape in major immunotherapy in the coming years.

To support our close plan, we have increased our headcount to a total of 89 employees during the second quarter of the year due to the Cobi 19, the increase is modest compared to prior quarters and the gross represent addition to the development team as well as to the commercial gene that is ramping up for the potential commercial launch of next it I'm not I don't.

Klaus Moeller: Due to COVID-19, the increase is modest compared to prior quarters, and the growth represents additions to the development team as well as to the commercial team that is ramping up for the potential commercial launch of Nexidermab and Amperdermab. With the PDUFA date in late November 2020, we continue to believe that we are well-positioned to move maxitumab to FDA approval and commercialization later this year. For ombretumab, we believe that we are well-positioned for potential FDA approval and commercialization in the beginning of 2021. Concurrently, we plan to increase our focus on constructs generated by the SATA technology and the earlier-stage product candidates in our pipeline, including the lutetium-labeled ombretumab and the bispecific antibody programs, as well as some next-in-line indications for maxitumab Now, let me invite Bo to share his remarks on the second quarter financials.

Matt.

With the PDUFA date in late November Twentytwenty, we continue to believe that be a well position to move next to them up to FTC approval and commercialization later this year.

But I'm happy believed that yeah, well put to position they did for the potential if da approval and commercialization in the beginning of Twentytwenty run concurrently we plan to increase I will focus on constructs generated by the start of technology and the earliest stage product candidates in our pipeline, including the to teach him label on both of them up and if I suppose.

I think antibody programs as well that's the next in line indications for next set them up and I'm, but I'm not.

Now, let me invite bow to share his remarks on the second quarter financials.

Okay.

Thank you class.

We reported a net loss for the quarter ended June Thirtyth your investments when a $40.4 million a one dollar and one cents per share basic and diluted this compares to net loss of 810 million a 53 cents per share basic and diluted for the quarter ended June Thirtyth 2019.

Bo Kruse: Thank you, Klaus. We reported a net loss for the quarter ended June 30, 2020, of $40.4 million, or $1.01 per share basic and diluted. This compares to a net loss of $18.53 million per share of Basic and Diluted for the quarter ended June 30, 2019. We ended the second quarter with a cash position of $158 million, compared with a 2019 year-end cash position of $207 million. As our work on the OmbertaMap BLA submission progressed through the quarter and as we continue to accelerate the commercial ramp-up for the potential launch of both Nexidimap and OmbertaMap, we have seen our cash burn increase. We expect the cash burn from operating expenses for the remaining quarters in 2020 to increase slightly but remain roughly in line with the last couple of quarters.

We ended the second quarter, where the cash position up 158 million compared with the 2019 year in cats position of 207 million. That's how we'll work on them burden might be a laser mission has progressed through the quarter and as we continue to accelerate the commercial ramp up for the potential launch a frozen exceed them up and embed them up.

We haven't seen I'll catch Bernie increased we expect the cash burn from operating expenses for the remaining quarters in 2020, <unk> increased slightly but remain roughly in line with last couple of quarters with respect to the reason announcement of Sensata license. We did not expect this material impact on our spending in 2020.

[noise] as would take a closer look at the operating expenses for the second quarter. We note that R&D expenses have increased by 16.6 million from 14.5 million for the quarter ended June Thirtyth 2019, just 30.1 million for the quarter ended June Thirtyth 2020. This increase was primarily attributable.

Bo Kruse: With respect to the recent announcement of the start-up license, we do not expect this to have a material impact on our spending in 2020. As we take a closer look at the operating expenses for the second quarter, we note that R&D expenses have increased by $15.6 million from $14.5 million for the quarter ending June 30, 2019 to $30.1 million for the quarter ending June 30, 2020. This increase was primarily attributable to a $1.8 million increase in personnel costs and a $13.3 million increase in milestones and license fees as per the SADA agreement. In the second quarter, most of the SADA-related expenses were non-CAS items.

So $1.8 million, increasing personnel costs and a 13.3 billion dollar increase in milestones and license fees as opposed to SATA agreement in the second quarter most of decided related expenses when noncash items.

<unk> expenses increased by six point Threemillion from 4.1 million for the quarter ended June Thirtyth 2019, So 10.4 million for the quarter ended June Thirtyth 2020.

The increase in DNA expenses, primarily reflects a 1.9 billion dollar increase in personnel costs.

A 3.5 million total increasing the expenses for the building up our commercial infrastructure related to the potential launch of our to lead product candidates next it I'm not going to bring them up and a point $9 million.

Bo Kruse: And GNA expenses increased by $6.3 million from $4.1 million for the quarter ended June 30, 2019 to $10.4 million for the quarter ended June 30, 2020. The increase in G&A expenses primarily reflects a $1.9 million increase in personnel costs, a $3.5 million increase in expenses for the building of our commercial infrastructure related to the potential launch of our two lead product candidates, Maxitamap and Ambratamap, and $0.9 million for business insurance and professional fees. Cash used in operating activities in the first half of 2020 shows that the cash burn increased by $21.9 million from $27.5 million for the period into June 30, 2019 to $49.4 million for the period into June 30, 2020. The increase was primarily caused by an increase in net loss for the period.

For business insurance and professional fees.

Cash used in operating activities in the first half of 2000 and trying to show that the cashman increased by 21 point Ninemillion from 27.5 million for the period ended June Thirtyth 2019 to 49.4 million for the period ended June Thirtyth 2020 increase was primarily caused by the income.

<unk> net loss for the period.

The net loss itself increased by 32.6 million for the period ended June 32020, and was partially offset by an increase in noncash expenses, including depreciation and stock based compensation of 11.7 million.

In terms of financial guidance since the secondary offering last year, we've said that cash on hand, plus net proceeds from the offering would cover operating activities and capital expenditures through the fourth quarter on like 2020 true.

Bo Kruse: The net loss itself increased by $32.6 million for the period ending June 30, 2020, and was partially offset by an increase in non-cash expenses, including depreciation and stock-based compensation of $11.7 million. In terms of financial guidance, since the secondary offering last year, we've said that cash on hand plus net proceeds from the offering would cover our operating activities and capital expenditures through the fourth quarter of 2022. This does not take into account any potential revenues from the commercialization of Maxidermab and Amperdermab or the proceeds from any potential future partnerships.

This does not take into account any potential revenues from commercialization of next to them up and the brighten up all the proceeds from any potential fuel future partnerships. So we believe.

That's why mass remains in a very healthy financial position.

This concludes the financial update and our long trend to called over to Thomas.

Thank you both thank you everyone. So Don if you will.

Open up folks you on a and just go through the process all that will work. Thank you.

Certainly it's a par is now open for questions. If you would like to ask a question. Please press star one on your telephone keypad at this time.

Confirmation total indicate your line is in the question Q. He May press star to if he would like to move your question from the Q.

Thomas Gad: Y-mAbs remains in a very healthy financial position. This concludes the financial update, and I'll now turn the call over to Thomas. Thank you, Bo. Thank you, everyone.

Participants using speaker equipment, and maybe necessary to pick up your handset before pressing the star Keith.

Once again, that's star one to register questions at this time.

Our first question is coming from Alex trying to hand of Bank of America. Please go ahead.

Operator: So, Donna, if you would open up for Q&A and just go through the process of how that will work, thank you.

Hey, guys. Thanks for taking my questions I'm too for me.

My first question is on the do you need to buy Cdthree by specific in the first indications that relapse refractory neuroblastoma and osteosarcoma as the hope here that we'll see better safety. The next to the manner in terms that the grade three pain or do you think we could also see a boost an efficacy given the higher.

Operator: The floor is now open to questions. If you would like to ask a question, please press star 1 on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing start.

Let's see in preclinical models in terms of timing of the data I think the recall you mentioned, we might see early evidence yet so I often the fall, but I didn't see it in the tells you listed so any additional color there on timelines for did or at least would be great.

And then my second question is on the commercialization fraud I know watch is still a few months away and things could change, but given the situation with co bid. How are you building the potential for extended social distancing and mobility issues into your approach to marketing next to them out and on Burton Mad and.

Alec Warren Stranahan: Once again, that's Star 1 to register questions at this time. The first question is from Alec Stranahan of Bank of America. Please go ahead. Hey, guys, thanks for taking our questions, two from me. My first question is on GD2 by CD3 by Specific. In the first indications of relapsed refractory neuroblastoma and osteosarcoma, is the hope here that we'll see better safety next to the MAB in terms of grade-free pain, or do you think we could also see a boost in efficacy given the higher potency in preclinical models? And in terms of timing of the data, I seem to recall you mentioned we might see early efficacy at PSYOP in the fall, but I didn't see it in the titles you listed, so any additional color on timelines for data release would be great.

How are you waiting boots on the ground versus a virtual interactions in your watch preparations. Thanks.

Thanks, I like I'm just I'm. Your first question to the bi specific antibody we are still hoping that during the fall you'll be able to come out with some preliminary data from the phase one two dose escalation study on on the by specific antibody and and and hopefully.

So some preliminary indication up both safety and efficacy.

The idea is that.

Due to the lower doses had been using that be potentially could see less pain side effects with this.

The patient it'd be a putting on study is patients that have already progressed, while having received TD two antibody, although we have a fantastic Mexican lucky to anybody you will recall fault for second line patients that on a that our secondary refractory. We only have about if you include those we can put didn't commissioning combinations.

Alec Warren Stranahan: And then my second question is on the commercialization front. I know launch is still a few months away, and things could change, but given the situation with COVID, how are you building the potential for extended social distancing and mobility issues into your approach to marketing next to the MAB and on Burton MAB, and how are you weighing boots on the ground versus virtual interactions in your launch preparations? Thanks.

Chemotherapy about 60% if the patient to come into remission, which also tells you that remaining 40% are still not information. So there's a significant unmet need still for those patients and of those 60% that does come into remission. Approximately if you look adopt a dr. Christmas data from side last year.

Klaus Moeller: Thanks, Alec. Just your first question about the bispecific antibody. We are still hoping that during the fall we will be able to come out with some preliminary data from the Phase 1-2 dose escalation study on the bispecific antibody and, hopefully, also some preliminary indications of both safety and efficacy. The idea is that due to the lower doses, we could potentially see less pain side effects with this. And the patients that we are putting on study are patients that have already progressed while having received GD2 antibody. Although we have a fantastic maxinomide GD2 antibody, you will recall for second-line patients that are secondary refractory, we only have about, if you include those, we can put in remission, in combination with chemotherapy, about 60% of the patients to come into remission, which also tells you that the So there's a significant unmet need still for those patients. And of those 60% that do come into remission, approximately, if you look at Dr. Kushner's data from PSYOP last year, you will see that the two-year progression-free survival for those that are coming into remission is about 37%. So there's clearly still more to be done for these kids.

You'll see that the two year progression free survival for those that are coming through in Michigan or about 37% to this clearly still more to be done for these kids. So so it's the bi specific antibody could help out initially it will be developed for those that I'm not staying in remission opt out first or second relapse.

Oh, and and then of course, you would try to advance it and see if you use it in earlier stage you can actually keep patients more patients and their mission for longer time and put more patient information with the product.

And for the Osteosarcoma patient did that the thing is today, that's nothing approved for patients that up beyond frontline treatment in osteosarcoma. So so that's definitely an unmet medical need there and and and I know we have at least a three or four osteosarcoma patients on study and we had no much hope to see how that lesson.

In terms of the commercialization well, we're definitely paying attention to the issue with what we've not seen and we are preparing to do a virtual launch.

Right now there's a limit to how much that can be done it seems to be all experienced munching. What other people are doing that positions us very openedge, but in particular to new products coming to the market through to do a virtual interviews and presentations. So so so we are preparing for that a situation that that'd be may not be.

Klaus Moeller: So if the bispecific antibody could help out, initially, it will be developed for those that And then, of course, you would try to advance it and see if you can actually keep patients more patients in remission for longer and put more patients in remission with the product. And for the osteosarcoma patient, the thing is, today there's nothing approved for patients that are beyond frontline treatment for osteosarcoma. So there is definitely an unmet medical need there. And I know we have at least 3 or 4 osteosarcoma patients in the study, and we are looking very much forward to seeing how that progresses. In terms of commercialization, we're definitely paying attention to the issue with COVID-19, and we are preparing to do a virtual launch.

Yeah, but you put seats on the ground and hospitals, but have to do the launch virtually so so I was discussing this than had been discussing this number of times a with Hilton heading the commercial team. So he's perfectly prepared for that situation also.

Did that answer your question.

Yes, that's perfect. Thanks, a lot and congrats on all the progress.

Thank you.

Thank you. Our next question is coming from that search <unk> of Guggenheim. Please go ahead.

Hi, Thanks for taking my question I guess, the first one on just done Danielle and I'm last says if you could maybe provide some commentary on on you know access pricing and reimbursement conversations that you're having with payers and how I'm sort of we're kind of communicating what you know you've kind of.

Klaus Moeller: Right now, there's a limit to how much that can be done. It seems, from our experience of monitoring what other people are doing, that positions are very open, in particular to new products coming to the market, to do virtual interviews and presentations. So we are preparing for that situation where we may not be able to put feet on the ground in the hospitals but have to do the launch virtually. So I was discussing this and have been discussing this a number of times with Phil, who heads the commercial team. So he's perfectly prepared for that situation also. Did that answer your question?

Characterizes optimal pricing and then.

Just just secondly, if you could you know maybe give a little bit more color on the data you've seen for a burden mabin adults.

And and sort of how that may be kind of read through to the lid Lutecia I'm proud of that show advancing in adult patients. Thanks.

Well, thanks for the questions and in terms of pricing it's difficult for me right now to give you any details on the pricing. We have previously discussed some some ballpark figures, where you you could expected pricing to end, but but I I think I've nothing.

Klaus Moeller: Yes, that's perfect. Thanks a lot and congratulations on all the progress. Thank you. Thank you. Our next question is coming from Etzer Darout of Guggenheim. Please go ahead. Hi. Thanks for taking the question. I guess the first one on just Danielza and Amlasis, if you could maybe provide some commentary on, you know, the access, pricing, and reimbursement conversations that you're having with payers and how we're kind of communicating what you've kind of characterized as optimal pricing. And then, just secondly, if you could, you know, maybe give a little bit more color on the data you've seen for Umbridamab in Thanks.

For the right now until but but I would in terms of price persistence I have to say that you're not meeting any and it doesn't matter, which kind of price level would be a discussing a within the levels where other people for these I'm very expensive a nice products Oh selling right now so so I don't foresee any issues with pricing.

Remember form but up to be it taking a group of kids where everybody is.

Historically expected to die from that the season BQM, 50% with them.

I think it's very hard not to start talking about pricing as long as Ah. That's just stay within a reasonable amount of Oh costs.

In in.

So so that's as much on pricing and the other question was.

Klaus Moeller: Well, thanks for the questions. In terms of pricing, it's difficult for me right now to give you any details on pricing. We have previously discussed some ballpark figures where you could expect the pricing to end, but I think I have nothing further until, but I would, in terms of price resistance, I have to say that we're not meeting any, and it doesn't matter which kind of price level we are discussing, within the levels where other people for these very expensive niche products are selling right now. So I don't foresee any issues with pricing. Remember, for Onbertumab, we are taking a group of kids where everybody is historically expected to die from the disease and be cured 50% of the time. I think it's very hard not to start arguing about prices as long as you stay within a reasonable amount of cost. Thank you. And so that's as much on the pricing.

But up an adult and yet and that.

We presented some preliminary data from the I had the native question I mean, many of these patient that went on the IDE and they didn't but I'm hopeful for CNS, let somebody got metastasis, strawberry and cancer, and so melanoma and cycle mass et cetera, that'd be have under study.

Well really terminal when they came onto to the to this to the or to the protocol I had the m. remember the woman with the deal Darien cancer had 14 metastasis that's visible on her scans when we put on the nevertheless units on a again, a hub, which is I would say unprecedented.

There's no doubt that you need to come as quickly as possible. If you want to get full benefit of a treatment like Dan but up other teach him.

So like for the kids, we put on this treatment, where we get these fantastic results remember before they come on the treatment.

They receive standard of care, which is induction chemo surgery and radiation to that you'll notice in the brain.

Klaus Moeller: The other question was... We presented some preliminary data from the iodinated version. I mean, many of these patients that went on the iodinated ombretomab for CNS-leptomeningo-metastasis for ovarian cancer and for melanoma and sarcomas, etc., that we have on the study were really terminal when they came on to the protocol.

After that they are expected median survival is six months from diagnosis of CNS disease, and the expected a two year old survivalist, 10%. So.

So.

These patients receiving optimal treatment if I'm the patient that you put on the adult protocol will be those that say that you have a melanoma relapsing into brain. They will also receive induction chemo with temozolomide and maybe some maybe that she can then and then they will get a surgery for that leasing that I've missed it.

Klaus Moeller: I remember the woman with ovarian cancer had 14 metastases that were visible on her scans when we put her on a nevertheless shillip for a year and a half, which is, I would say, unprecedented. There's no doubt that you need to come as quickly as possible if you want to get the full benefit of a treatment like Ambutamab Lutetium. So, like for the kits, we put on this treatment where we get these fantastic results.

And then they look at whole brain radiation or probably 25, gray total and and after that most of the patients will be any D and nevertheless, the likelihood that they will be at I've 12 months later is 15%.

Klaus Moeller: Remember, before they come on the treatment... They received the standard of care, which is induction chemo, surgery, and radiation to their tumors in the brain. Their expected median survival is six months from the diagnosis of CNS disease, and their expected three-year-old survival is 10%. Hence, these patients are receiving optimal treatment. If I'm right, the patients that you put on the adult protocol will be those that say that they have melanoma relapsing in the brain. They will also receive induction chemo with semisolamide and maybe some irinotecan, and then they will get surgery for the lesions that are visible, and then they will get whole brain radiation, probably 25 Gray total. And after that, most of the patients will be NED, and nevertheless, the likelihood that they will be alive 12 months later is 15%.

So those patients just after they finish that would be optimal to put on this based also on the experience. We have we have treated a number of melanoma patients and and again as it most of them come.

At a time point, where there's no outspend of chips and then.

They have received but ever palliative care they could receive.

I hope that answers your question to the extent great Yep. Thank you for the color and congrats on all the progress.

Thank you very much.

Thank you. Our next question is coming from Robert Burn Some H.C. Wainwright. Please go ahead.

Hi, guys. Thanks for taking my question Congrats on the progress just a few permit if I'm right.

So since your advancing both the GDP to buy specific Amici D to data asset could you discuss the potential overlap of these assets and then what setting you believe each is likely to be preferentially you as well as whether you see any possibility for cannibalization of the others revenue potential, particularly in Es.

Klaus Moeller: So those patients, just after they finish that, would be optimal to put on this, based also on the experience we have. We have treated a number of melanoma patients, and, again, as I said, most of them come at a time when there's no other alternatives. They have received whatever palliative care they could receive. I hope that answers your question to the extent possible. No, great. Thank you for the color and congrats on all the progress. Thank you very much.

Ill see an add one more after that.

Yeah.

Okay. So initially first well of course, there's a potential that then one of them. Good cannibalize the other one but remember one is right now.

In the early preclinical testing, meaning we are getting ready for tuck studies, it will probably into the clinic.

By the Middle of next year third quarter next year.

That's it SATA construct the other one is ready to start three phase two studies later this year.

And when we started this development.

We didn't have decided technology.

Klaus Moeller: Thank you. Our next question is coming from Robert Burns of H.C. Wainwright. Please go ahead. Hi guys. Thanks for taking my questions and congrats on the progress. Just a few from me, if I may. So, since you're advancing both a GD2 Buy Specific and a GD2 Stata Asset, could you discuss the potential overlap of these assets and in what setting you believe each is likely to be preferentially used, as well as whether you see any possibility for cannibalization of the other's revenue potential, particularly in SCLC?

And we don't know how this out of technology will work in in patients remember, it's never been in patients before but if the satellite technology works.

The way I believe it's working it's going to be the biggest game changer that'd be I've seen in oncology for the last 30 years and then it's kinda competing completely compete out the bi specifics.

Then it has the potential to compete out basically anything.

The SATA constructs are only dependent on the receptor on the cancer cells.

As long as you can identify something that is selectively to some degree expressed not even on all the cancer cells because radiation from to teach them penetrates like one to 1.5 millimeters in Kansas tissue.

Robert John Burns: And then I have one more after that.

So you get a ton of by saying they think some of these regulate the punch drops.

Klaus Moeller: Okay, so first, well, of course, there is a potential that one of them could cannibalize the other one, but remember, one is right now. In early preclinical testing, meaning we are getting ready for top studies, it will probably enter the clinic by the middle of next year, the third quarter next year. That's the SADA construct.

Whereas it by specific antibody is dependent on T cell activation.

And naked antibody like next cinemark is dependent on NK cells, and macrophages and ADCC activation.

These constructs even if I take a late stage patients that had been true for five different regimens of Kansas therapy has no immune system that is really working anymore, but the Kansas still expressing the target and it the patient has hundreds of my company test. This is.

Klaus Moeller: The other one is ready to start three phase two studies later this year. And when we started this development... We didn't have this sort of technology. And we don't know how the SATA technology will work in patients. Remember, it's never been used in patients before. But if the SATA technology works the way I believe it is working, it's going to be the biggest game-changer that we have seen in oncology for the last 30 years, and then it's going to completely compete with the bystanders. Then it has the potential to compete with basically anything. The SARTA constructs are only dependent on the receptor on the cancer cell, so long as you can identify something that is selectively expressed to some degree, not even on all the cancer cells, because radiation from lutetium penetrates like 1 to 1.5 millimeters into cancer tissue. So you get a ton of bystander effect from these radiolabeled contrasts.

My SATA construct will still work it just gonna go in there and eat it.

So.

If the SATA works I would agree that it could potentially cannibalize anything that next set them up and ER and the bi specific T. Two but I've been long enough in this industry to know that you should not abandoning the stuff that you have coming to them I could just because your belief that something in your research lab looks more interesting, but it shouldn't stop us from pushing that forward and I.

I have to say and I've said it many times already now I'm extremely excited about about all this out of technology. It as it is really the best stuff I've seen since I started working with anti bodies backing the 19 eighties into different but then you know.

Did that answer the question.

Oh, it's certainly did I certainly look forward to a the whole SATA constructs a one more for me. So considering that you know why not as it is eligible to receive a PRB upon approval of an accident that enom burden that have you already lined up potential buyers for them.

Klaus Moeller: Whereas a bispecific antibody is dependent on T cell activation, a naked antibody like Naxinimab is dependent on NK cells and macrophages and ADCC activation. These constructs, even if I take a late stage patient that has been through four or five different regimens of cancer therapy, has no immune system that's really working anymore, but the cancer is still expressing the target, and the patient has hundreds of micro metastases, my SATA construct will still work. It's just going to go in there and eat it.

We have lined up some people that will help us make sure we get the best possible price for it [laughter], so but I know also from one after he said that the last two want that they were involved in selling took a three to four weeks to sell.

Then you may have seen that there wasn't otherwise that that was sold about a week ago $400 million.

Klaus Moeller: If the SATA works, I would agree that it could potentially cannibalize anything Max Sedema and the bispecific DD2. But I've been long enough in this industry to know that you shouldn't abandon the stuff that you have coming to the market just because you believe that something in your research lab looks more interesting. But it shouldn't stop us from pushing that forward. And I have to say, and I've said it many times already, I'm extremely excited about our SATA technology. It is really the best stuff I've seen since I started working with antibodies back in the 1980s in a different way than you are today. Did that answer the question? Oh, it did indeed.

Yeah that seems to be what they're going for roughly a world class Congrats again on the progress.

Thanks, a lot Rob.

Thank you. Our next question is coming from David Leibowitz of Morgan Stanley. Please go ahead.

Thank you very much for taking my question given that you had to be L.A.'s that are currently in progress.

Have you had any discussions with the agency regarding how facility inspections will be conducted for both applications.

Yeah.

I don't I don't foresee any problems in that context, and they have also been monitoring sites.

And having the many isn't that contacts either.

But that is that that could potentially be.

Klaus Moeller: Oh, it certainly did, and I certainly look forward to the whole set of constructs. One more from me. So, considering that Y-mAbs is eligible to receive a PRV upon approval of Noxidimab and Embrinimab, have you already lined up potential buyers for them?

In a challenge if the F. day cannot go and inspect the I'm photomask facility in France.

And first quarter, Nick yes, but I.

Would be surprised if that's not the case.

I mean, we then at a time point, where at least a lot of the big comments I promise that there will be vaccines available in the hundreds of millions of doses.

Robert John Burns: We have lined up some people that will help us make sure we get the best possible price for it. But I know from one of these that the last two ones that they were involved in selling took three to four weeks to sell. And you may have seen that there was another one that was sold about a week ago for $100 million.

So but for next set them up I don't foresee any figures.

And no one additional question with respect to radio label products.

How would you I guess juxtapose the U.S. market versus the.

Klaus Moeller: Yeah, that seems to be what they're going for, roughly. Well, thank you, Klaus, and congrats again on the progress. Thanks a lot, Rob. Thank you. Our next question is coming from David Leibowitz of Morgan Stanley. Please go ahead. Thank you very much for taking my question. Given that you have two BLAs that are currently in progress, have you had any discussions with the agency regarding how facility inspections will be conducted for both applications?

European market, and how such therapy or you've been delivered.

The report a commercial delivery side, we have moved in South Bend, a indiana in the U.S.

And and we are planning in the next 12 months to open a second side in Europe.

In addition to that we also working on an additional U.S. side. So so but we have the side that is basically a part of the BLE is into U.S. and the European approval will not come until probably towards the end up 21.

David Matthew Nierengarten: Yeah. I don't foresee any problems in that context, and they have also been monitoring sites and haven't seen any issues in that context either. But there could potentially be. It's a challenge if the FDA cannot go and inspect the ombudsman facility in France in the first quarter next year. I would be surprised if that's not the case. I mean, we're at a time point where at least a lot of the big pharmas have promised that there will be vaccines available in hundreds of millions of doses. So, except for Nexidermab, I don't foresee any use.

So we should be up and running with the European side of that time point also.

But we can see I keep them they decide in Indiana. It's no problem partnership we already doing that shipping from U.S. to Europe from father clinical trials and having the product available at the hospital into time for use.

Thank you for taking my question.

Thanks, David.

Thank you once again, if you do have a question you May press Star 100 telephone keypad. Our next question is coming from Peter Lawson of Barclays. Please go ahead.

Hi, Thanks for taking my questions I've just on the data fund that fits if not that looks really encouraging just what's the pushback that you've had.

Klaus Moeller: And one additional question. With respect to radio-labeled products, how would you, I guess, juxtapose the U.S. market versus the U.S. market and the European market and how such therapies are used and delivered?

Outside M.S.K. Cc and you know how to go to come live.

Well.

I would say I don't think they have had any significant pushed back you know it it's Ah I mean.

Klaus Moeller: The first commercial delivery site we have is in South Bend, Indiana, in the U.S., and we are planning in the next 12 months to open a second site in Europe. In addition to that, we're also working on an additional U.S. site. But we have the site that is basically a part of the BLA in the U.S., and European approval will not come until probably towards the end of 21, but we can ship it from the site in Indiana; it's no problem for us to ship; we're already doing that, shipping from the U.S. to Europe for the clinical trials and having the product available at the hospital in due time for you.

It's really opt to crews back when you have a treatment that you're right now he sites outside definitely understand I've been out pinnacle trial. They will use dyno talks him up in second line patients.

Yes, I blew chemotherapy.

And that gave us about a 40% response rate.

And we come here where they.

Naked antibody therapy in an outpatient setting.

Without chemotherapy and we get much better responses.

So so I mean.

I I I haven't heard any.

Real qualified arguments why you would not use this and second line and.

David Matthew Nierengarten: Thank you for taking my questions.

It's hard for me to imagine that any doctor wouldn't use next set them up in primary secondary refractory patients according to indication.

Klaus Moeller: Thanks, David.

Peter Lawson: Thank you. Once again, if you do have a question, you may press star 1 on your telephone keypad. Our next question is coming from Peter Lawson of Barclays. Please go ahead. Hi. Thanks for taking my questions. Just on the data for the Naxibis map, that looks really encouraging. Just what's the pushback that you've had outside MSKCC and, you know, how do you overcome that?

And brought up go for something else and you cannot go if they say, but I want to use it I want to use the antibody in combination with chemotherapy. We have a two studies out there where we use the nations with chemotherapy and we're getting very nice results. They also I'm, you're starting a center.

Klaus Moeller: I would say I don't think we have had any significant pushback. It's really hard to push back when you have a treatment that you're currently, right now, outside of MSK, and if they're not in our clinical trial, they will use dinotoximab in second-line patients. Together, we're chemotherapy, and that gives about a 40% response rate. And we come here with Naked Antibody Therapy in an Outpatient Setting, without chemotherapy, and we get a much better response. So, what do I mean?

I'd very soon this year also all in chemo combination so.

I I haven't heard any concrete arguments against that's a said that's that's a lot of people that I'm happy that they have access to a diamond talks about and I used to get boson front in second line, but doesn't mean that they will then when there is something that can be used in an outpatient setting where lets side effects why wouldn't be.

Okay. Thank you and then well be doing.

Klaus Moeller: I haven't heard any real qualified arguments why you would not use this in the second line. It's hard for me to imagine that any doctor would not use Nexidermab in primary, secondary, refractory patients according to indication and would rather go for something else, and you can argue if they say, but I want to use the antibody in combination with chemotherapy. We have two studies out there where we use it in combination with chemotherapy, and we are getting very nice results there also, and we are starting a Moose Center study very soon this I haven't heard any concrete arguments against it; as I said, there are a lot of people that are happy that they have access to Dimetoximab and are using it, both on the front line and second line, but it doesn't mean that they will then. When there's something that can be used in an outpatient setting with less side effects, why wouldn't they?

On call you a lot of the treatment is driven by the parents. So so the parents will also have a lot of saying about this area. The dog tells you I'm going to treat your Kid Andy intensive care units for eight days in combination with chemotherapy and maybe some significant side effects, but but I think it's a good treatment for you or second line patients here and the pair.

No that there's an FDA approved product for second line patients that can be done in an outpatient setting without chemotherapy.

I mean.

They're going to ask the Doctor why on Earth, she would not be using that.

And how much what they do you have to do with patient advocacy groups.

Well I mean of course, we aren't dialogue with them and talking to them and they are definitely aware of it we have been in dialogue with them. Since we started working for them I mean, why that's five years ago.

Mean that there's all came to some degree out of there that patient advocacy groups. So so so we have a very close dial up ammonia, but it's not kind of like that that.

Klaus Moeller: This is Pediatric Oncology. A lot of the treatment is driven by the parents, so the parents will also have a lot to say about this. If the doctor tells you, I'm going to treat your kid in the intensive care unit for eight days in combination with chemotherapy, and there may be some significant side effects, but I think it's a good treatment for your second-line patient here. And parents know that there's an FDA-approved product for second-line patients that can be done in an outpatient setting without chemotherapy. They're going to ask the doctor why on earth she would not be using that.

They are independent groups and of course useful to respect that but but of course, we have a dialogue with them.

And they are fully up and then what goodwill.

Thank you and then the pivot to what I want to sit here S&P.

The ship what should we expect to see an update of what should we be looking for.

Well I mean, I'm a thought for the I'm buttoned up a week, we definitely see planning to present some of the data from this study one or one or the multicenter study and on and also the survival data that we have available at that time point.

Klaus Moeller: And how much work do you have to do with patient advocacy groups?

And FFO for the two one study again that the data used for the if FDA filing and the updated data from that study. So whatever it is available in terms of updated data remember the the data set that was lost percentage from the and a lot of one study was oh well to cut off date.

Klaus Moeller: Well, I mean, of course, we are in dialogue with them and talking to them, and they are definitely aware of that. We have been in dialogue with them since we started working with Y-mAbs five years ago. I mean, this all came to some degree out of patient advocate groups, so we have a very close dialogue with many of them, but it's not like that. They are independent groups, and of course, we fully respect that, but of course, we have a dialogue with them. And they are fully aware of what they are doing.

That is almost a year ago and the same goes for the.

For the two a one data the data cut off for the two a one study was in.

July 1st 2019, so we have more than a year off additional follow up on the patient there.

Great and then the bi specific that because I thought that was gonna be as I said piece that.

Klaus Moeller: And then the pivotal one-on-one study at SIOP later this year, what should we expect to see in that data? What should we be looking for?

That's been delayed kind of cobot related issues or.

Yeah, well I mean.

Klaus Moeller: Well, I mean, for the BertaMap, we definitely would be planning to present some of the data from study 101, the multi-center study, and also the survival data that we have available at that time point. And for the 201 study, again, the data used for the FDA filing and the updated data from that study, so whatever is available in terms of updated data. However, the data set that was last presented from the 101 study was with a cutoff date that is almost a year ago, and the same goes for the... data for the 201 study. The data cutoff for the 201 study was on... July 1st, 2019, so we have more than a year of additional follow-up on the patients there.

No that.

We have decided not to stop dose escalating and and.

The [noise].

Well that's the first one eight looking abstract is that this study is not ongoing.

So since its still dose escalating.

But I have to say that that we're not beyond the cohort to six also we need to you're working with some ways to handle some of the side effects that'd be a team so but but it's not that we are expecting it to delay any of the timelines for still planning for going into the phase two studies, but of course, we want to make sure that we aren't as high.

Dose level as we can be.

And to sneak if we can get beyond the cohorts six level.

[noise] quick things first thanks for taking my questions much appreciated.

Sure absolutely Peter.

Once again that is star one to register questions at this time.

Klaus Moeller: And then the, by specific, that was, I thought that was going to be at SAOP, is that... That's been delayed because of COVID-related issues.

Next question, it's coming from our you Palm Rama JP Morgan. Please go ahead.

Klaus Moeller: Yeah, well, I mean, the thing was that we have decided not to stop dose escalating, and the... The requisite for a late-breaking abstract is that the study is not ongoing.

Where are you guys. This is on the call. This morning.

Thank you for taking my questions I know rolling submission for I'm sorry, Bob.

But just announced that's complete yesterday.

Klaus Moeller: So, since it's still escalating, but I have to say that we're not beyond Cohort 6. Also, we need to, and we're working with some ways to handle some of the side effects that we are seeing. So, but it's not that we are expecting it to delay any of the timelines; we're still planning to go into the Phase 2 studies, but of course, we want to make sure that we are at as high a dose level as we can be and to see if we can get beyond the cohort 6 level.

What is something that stops and key interaction with regulators I actually had towards a potential approval.

Well the F. day, now has 60 days to make up their minds, whether they believed that the beauty is complete or whether it's oh faulty and they are there for should be returned over shoes to file and typically. So then you receive what's called a day 75 letter which means.

Klaus Moeller: Great. Thank you so much. Thanks for taking all my questions. Much appreciated.

Operator: Sure, absolutely, Peter.

That DFT typically 75 days. So if you don't get every Schuster filed within 60 days you get a day 75, let out that includes you a PDUFA date, which will then be six months. After the 60 days I eight months out to you filed.

Tessa Thomas Romero: Once again, that is Star 1 to register questions at this time. Our next question is coming from Ayupam Rama of J.P. Morgan.

Klaus Moeller: Please go ahead. Morning, guys. This is Tessa on the call this morning for Anupam. Thank you for taking our questions. The rolling submission for Umberto Babb has now been, was just announced as complete yesterday. What are some of the next steps and key interactions with regulators as we head towards a potential approval?

Oh competed you're rolling delay.

But that they 75, let it doesn't necessarily come.

15 days off of the day 60, it can come I must say after if they have some questions and and stuff and also for for the next set them up a we had an interaction with the FDA already in the first 60 days, where they asked us for what they called an application orientation meeting.

Klaus Moeller: Well, the FDA now has 60 days to make up their minds whether they believe that the BLA is complete or whether it's faulty and therefore should be returned or refused. And typically, then you receive what's called a Day 75 letter, which means that the FDA typically takes 75 days, so if you don't get a refusal to file within the 60 days, you get a Day 75 letter that includes your PDUFA date, which will then be six months after the 60 days, i.e. eight months after you file or complete your role in BLA. But the Day 75 letter doesn't necessarily come 15 days after day 60.

And when and where they had a ton of people available to get to make sure that they had to complete understanding of the various parts of the filing.

So so that's that's going to be I think already from within the next two to three weeks at beginning correspondence with I Fies request for information from the agency. So so that as for the next set them up since we completed the rolling DNA and and March we have.

Klaus Moeller: It can come a month later if they have some questions and stuff. And also, for the next set of maps, we had an interaction with the FDA already in the first 60 days where they asked us for what they called an application orientation view, and where they had a ton of people available to make sure that they had a complete understanding of the various parts of the filing. So there's going to be, I think, already within the next two to three weeks, a beginning correspondence with the RFI's request for information from the agency. So as for Nexidimab, since we completed the rolling BLA in March, we have had a number of conference calls and discussion meetings, et cetera, with the agency. So this is a continuing dialogue. You don't just sit down and wait six months and then cross your fingers and hope that they are happy with everything.

But I am a number of conference calls and discussion meetings et cetera with the agency.

So this is a continued dialogue you just you don't just sit down and weight all six month, and then cross your fingers and hopefully they are happy with everything that's about us dialogue.

I'm very constructive and I think also because we have breakthrough designation DFT has also before we file giving us a lot of construction advice. The boasts filing. So so we have I think we have a great and very constructive dialogue with the agency on these two filings.

Great. Thank you for taking my question.

Okay great.

Thank you. Our next question is coming from Peter Larson of Barclays. Please go ahead.

Thanks for taking the follow up just on the the SATA construct for Robin.

Seven heights, three and prostate cancer when could we see the initial data there and when do you think it works in prostate cancer and is that based on your run data room pit data.

Klaus Moeller: There's a lot of dialogue, very constructive. And I think also, because we have breakthrough designation, the FDA has also, before we filed, given us a lot of constructive advice for both filings. So I think we have a great and very constructive dialogue with the agency on these two filings.

[noise] well, that's a lot of documentation that be seven nights tree is highly expressed on on the prostate cancer and and the construct that we're using here remember the that's him up antibody is a move right into Buddy I T. One and the the constructed.

Tessa Thomas Romero: Great, thank you for taking our questions. Okay, great. Thank you. Our next question is coming from Peter Larson of Barclays. Please go ahead. Hey, thanks for taking the follow-up. Just on the SADA construct for... When can we see the initial data, and why do you think it works in prostate cancer, and is that based on your own data or peer data?

Finding a single channel, we again CD disseminate street that'd be using for the side or is that humanized.

Portion of the antibody that's modified so it doesn't seem to cross react with any liver tissue, which can be the issue with some by specific Oh, some b seven athree antibodies. So it's a modified version that that be at least based on where do you have seen in the research do not expect to crush Vic liver tissue.

Peter Lawson: Well, there's a lot of documentation that B7H3 is highly expressed in prostate cancer. And the construct that we are using here, remember the umbertumab antibody is a murine antibody, IgG1. And the construct, the binding single chain, if we again see the B7H3 that we are using for the SADR is a humanized version of the antibody that's modified. So it doesn't seem to cross-react with any liver tissue, which can be the issue with some B7H3 antibodies. So it's a modified version that we, at least based on what we have seen in the research, do not expect to cross-react with liver tissue. And the reason for going for this, I mean, prostate cancer is a huge indication. And with the SATA technology, a part of that technology package, you know the other part of the SATA construct binds DOTA molecules, and DOTA is obvious for lutetium because it works as a chelator, but we also, as part of the package, have a technology we call Proteus, and Proteus is a benzyl binder that can carry actinium linked to the donor.

And that the reason for going for this I mean prostate cancer shoes indication.

And with the with the SATA technology, a part of that technology package.

You know the other part of de SATA constructs binds dota molecules and Dota, it's obvious for to teach them because it works as a key later, but we also as a part of the packets have.

Technology be called Proteus and the pro Joe's is that it's been side binder that can carry a actinium.

Linked to the Delta.

So that means that and you know that prostate cancer is very sensitive to l. time at us and a one off the idea is that said we want to use the proteus construct to as and that's an l. time it against the the prostate cancer and the nice thing here is that.

It's just kinda find any micro metastasis expressing vseven eighth street and even if it's only one in 10 prostate cancer cells, that's expressing it whereas we normally you know that it's more than 90%.

Peter Lawson: So that means that and you know that prostate cancer is very sensitive to alpha emitters and one of the ideas is that we want to use the Proteus construct as an alpha emitter against the prostate cancer and the nice thing here is that you know it's just going to find any micro metastasis expressing P7H3 and even if it's only one in ten prostate cancer cells that's expressing it whereas we normally know that it's more than 90%, it's going to kill all of them because although the alpha emitter is not penetrating a millimeter but maybe just 1.1 or 0.2 millimeters, it's still extremely lethal to the cancer cells. So it just made a lot of sense for us with the knowledge that's out there about prostate cancer and B7H3 expression and since we had the construct to start working on it and of course we started working on it quite a while ago and just kept pushing it until we had a construct that we felt comfortable moving forward to actual CTMP production for. Did that answer the question? It did. Other than when could we see data? I don't know. As soon as we can get some more presenters.

It's kinda kill all of them because although the l. somebody does not penetrating and millimeter, but maybe just one point 0.1 off 0.2 millimeter. It's it's still extremely tilted to the Kansas else itself. So it. It's it just made a lot of sense for us with the knowledge sets out there about prostate cancer and B seven eight street expression and since we.

He had to construct a to stop working on it and that's because we started working on its quite a while ago and I'm just kept pushing it until we had to construct and be felt comfortable control what you actually see Tempe production for.

Did that answer the question, but.

It did other than what could we see data.

[laughter] I don't know people [laughter] do unless we can get somewhat because [laughter], you're trying to push to have some preclinical data out there or what kind of hold that back.

Well, I mean, dasan, but but we don't we would have to put together paper, it's not something that would go west for it and all presentation I'm says would be could put together a pay before it but I honestly I think that the interesting thing here is because you know even if I showed you a ton of animal data that this works perfectly into mice.

Klaus Moeller: If you wish to have some preclinical data out there, or kind of hold that back.

Let's get it into patients that what matters.

Klaus Moeller: Well, I mean, there are some, but we would have to put together a paper. It's not something that would go west for an oral presentation, so we could put together a paper on it.

Habits was yeah whenever we have tox data available also true to share that that whatever we see there and get into it but the key thing that drives this is actually having as she can't be production available and approved <unk> and get the stuff into patients.

Klaus Moeller: But honestly, I think the interesting thing here is that even if I showed you a ton of animal data that this works perfectly in mice, let's get it in the patient. That's what matters. And happy to share whenever we have toxicology data available also to share whatever we see there and get in there. But the key thing that drives this is actually having a CTMP production available and an approved IND to get the stuff in the patients.

And then there's the bus specific dated would you end up just press releases that you want to try and find a venue.

Oh I'll get back to you, whether we do one or the other.

But it's still kind of yearend.

We should see Josephine, yes, yes, well have some plans, but they're not final Jed so Adam and it's definitely our intention to present data before them to you.

Klaus Moeller: And then the buy-specific data, would you end up just press-releasing that, or would you want to try and find a venue?

Perfect. Okay. Thanks much.

Thank you at this time I would like to turn the floor back over to management for any additional are closing comments.

Klaus Moeller: I'll get back to you whether we do one or the other.

Thank you I mean, thank you everyone. Thank you close. Thank you both thank you for all the great questions on.

Klaus Moeller: But it's still kind of year-end. We should see by those... We should see by those...

Klaus Moeller: Yes. We have some plans, but they are not final yet. And it's definitely our intention to present the data before the end of the year. Perfect.

This concludes our cold on.

I have a great day.

Ladies and gentlemen, thank you for your participation you may disconnect your lines to log off the webcast at this time and have a wonderful day.

Peter Lawson: Perfect. Okay.

Operator: Thank you so much. Thank you. At this time, I would like to turn the floor back over to management for any additional or closing comments.

[music].

Thomas Gad: Thank you. I mean, thank you, everyone. Thank you, Klaus. Thank you both. Thank you for all the great questions. And this concludes our call. Have a great day. Ladies and gentlemen, thank you for your participation. You may disconnect your lines or log off the webcast at this time, and have a wonderful day.