Full Year 2020 Y-mAbs Therapeutics, Inc Earnings Call

Greetings and welcome to <unk> fourth quarter and full year 2020 earnings conference call.

Operator: And welcome to Y-mAb's fourth quarter and full year 2020 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Thomas Gad, Chairman of Y-mAbs. Thank you, sir. You may begin.

At this time all participants are in a listen only mode.

A brief question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host Thomas Gad Chairman of why Matt. Thank you Sir you may begin.

Thank you.

Thomas Gad: Thank you, and thank you, everyone. Good morning, and thank you for joining us today.

Thank you everyone. Good morning, and thank you for joining us today.

Thomas Gad: So, 2020 was the year that we believe was truly transformational for Y-mAbs as we became a commercial stage company. We've made significant progress on executing our strategy and expanding significantly on our three pillars of business. First, our leading monoclonal antibodies, Danielle Phan-Ombudsman. Second, bi-specific compounds under the Y-Biclone tech platform.

So 'twenty and 'twenty was together, we believe once they're truly transfer.

Transformational for Wimax as we speak.

And a commercial stage company.

And we've made significant progress on executing our strategy on expanding significantly on all three pillars of business.

First of all leading multiple antibodies, Danielle sound and berths for Matt.

Second of all by specific compounds and look at why bikes zone Tech platform and finally, the Sada technology platform.

Thomas Gad: And finally, the SADA technology platform. As you know, we received U.S. approval for Danielsa in primary refractory and relapsed high-risk neuroblastoma on November 25, 2020. And from the beginning of February, we've been delivering Danielsa not only to MSK but to hospitals throughout the U.S., so that's very exciting. On Virtus.net, we continue to focus our efforts and work very hard on resubmitting the BLA as soon as possible. After receiving the refuse-to-fire letter from the FDA, we've had multiple interactions with the agency.

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As you know we received U S approval for Danielle so.

And primary refractory and relapsed high risk neuroblastoma on November 25th 'twenty and 'twenty.

And from the beginning of February we have been delivering Danielle so not only to amoskeag book to hospitals throughout the U S. So that's very exciting.

For <unk>, we continue to focus.

Oh airports and worked very hard on resubmitting, the BLA as soon as possible.

After receiving the refuse to file letter from the F D. A.

<unk> had multiple interactions with the agency.

And I'd now scheduled a type b meeting with the FDA on March 'twenty, six 'twenty and 'twenty, one where we will be presenting well. We believe we will have addressed the additional data request from D. S. P. A.

Thomas Gad: And I've now scheduled a type B meeting with the FDA on March 26, 2021, where we will be presenting what we believe will have addressed the additional data request from the FDA and thus aiming for a near-term resubmission, now likely to be finalized by the end of the second quarter or in the third quarter. We are very pleased and excited to see our next generation, Lutetium conjugated on Bertramat DTPA, enter into the clinic for B7H3 positive adult brain metastases and for pediatric brain tumors here in this quarter, 2021.

And also aiming for near term Resubmission.

Now likely to be finalized by the end of the second quarter or in the third quarter.

Yeah.

We are very pleased and excited to see all and next generation.

Lutetium conjugated on Burns from a D C P E and zone.

And to the clinic for B seven H three positive.

Adult brain metastases and for pediatric brain tumors here this quarter 'twenty and 'twenty one.

Addressing a very large unmet medical need.

Thomas Gad: Addressing a very large unmet medical need. Following the approval of Danyelsa, we then entered into a licensing agreement for both Danyelsa and Ombudsman with Cyclone Pharmaceuticals for Greater China, which included a $20 million upfront payment and up to an additional $100 million in approval and commercial milestones. Here, we submitted our free BLA package for Danielsa in China at the end of January this year. We have also signed a licensing agreement with Takeda Israel for Israel and are on schedule to submit a local BLA package this quarter as well. We entered into a distribution agreement with Schwick's Pharmaceuticals covering Eastern Europe and Russia.

Following the approval of Dundee also we mentioned and into a licensing agreement for both Danielle So and burns from up.

With cyclone pharmaceuticals for greater China.

Switching to you and at a $20 million upfront payment.

And up to an additional $100 million and approval and commercial milestones.

Yeah, we submitted all.

Pre BLA package.

And what Danielle and in China at the end of January this year.

We have also signed a licensing agreement with Takeda Israel for Israel.

And on schedule to submit a local BLA package and this quarter as well.

We entered into a distribution agreement with <unk> Biopharmaceuticals.

Covering eastern Europe and Russia.

And we will continue to aim to add more ex U S and ex EU territories to optimize the international availability of both and you also and our birth, but two.

Thomas Gad: And we will continue to aim to add more ex-U.S. and ex-E.U. territories to optimize the international availability of both Tanielsa and Ambertumat for pediatric patients. Our bi-specific programs under the Wi-Fi Clone Tech tab continue to advance as well. Our IND for nabatrotumab was cleared last year, and we are getting ready to dose the first patient soon in a Phase I-II study in small cell lung cancer. And in addition, we are planning on Phase I-II Expansion in neuroblastoma and osteosarcoma later this year. Our CD33, CD3 by specific, for Pediatric AML is scheduled to enter the clinic in late 2021.

Deep to pediatric patients.

Oh and by specific programs under the Wifi flow and checks that phone from.

Two items as well as well.

Oh and D for Nava trucking about what's clear last year, and we're getting ready to dose the first patient soon and a phase one two study and small cell lung cancer.

And in addition, we are planning on.

I, just want to expansions and neuroblastoma and osteosarcoma later this year.

Our CD 33, CD three by specific.

For pediatric AML is scheduled to enter the clinic and late 'twenty and 'twenty one.

And and addressing a very important unmet medical need for pediatric patients.

Thomas Gad: Again, addressing a very important unmet medical need for pediatric patients, satellite technology continues to look very promising. We've disclosed four targets thus far, and lab work is progressing as planned. We plan to submit an IND, our first R&D application later this year, and we have received positive feedback on our pre-R&D package submitted earlier this year. We ended 2020 with approximately $115 million in cash and subsequently closed the sale of our Danielle's Priority Review Voucher for $105 million, of which we got to keep 60% of $62 million after sharing 40% with MSK.

The Sada technology continues to look very promising.

We've disclosed for targets this far and lap works progressing as planned.

We plan to submit and IMT.

Our first R&D later this year and we have received positive feedback from our pre R&D package submitted earlier this year.

We ended at 'twenty, and 'twenty with approximately $115 million and cash.

And subsequent and subsequently closed the sale about and the other priority review voucher for $105 million.

Of which we got to keep 60% for $62 million after shank, 40% with M. S. K.

And I did earlier this week, we completed an oversubscribed secondary offering led by JP, Morgan and Morgan Stanley and Bank of America.

Thomas Gad: In addition, earlier this week, we completed an oversubscribed secondary offering led by J.B. Morgan, Morgan Stanley, and Bank of America. We sold approximately 2.8 million shares of our common stock, including the full exercise of the O-allotment option. It's a high-quality book of investments. That's $41 a share, and that netted us approximately $108 million in net proceeds.

We sold approximately two 8 million shares of our common stock.

Including the full exercise of the over allotment option.

For a high quality book of investors.

At $41, a share and that and netted us approximately $108 million and net proceeds.

This further strengthens our balance sheet to not only support Takomas criminalization of day Nielsen and the potential launch of them perhaps on that.

Thomas Gad: This further strengthens our balance sheet to not only support the criminalization of Danielle and the potential launch of Embryo Pneumonia but to enable us to advance both our next generation, on Bird2Math, and Nivetrucumab into later stage clinical development. At the same time, we continue to advance our two tech platforms with Y-Biclone Compounds and the Sharder Compound. And that's progressing very nicely, so we are very pleased with everything. Very, very, very solid financial balance sheet at this point, which Bo will elaborate more on in this call.

But to enable us to advance both our next generation.

And perhaps for Matt.

And neither children into later stage clinical development.

At the same time, we continue to advance our true check platforms would white box low comp.

Why bikes, so blackstone compounds and dishonour compounds and.

And that's progressing very nicely.

So we are very pleased with our overall.

Very very very solid financial balance sheet at this point, which Bo will elaborate more on and that's cool.

Chicken Oh achievements into consideration, we believe we have consistent why and that's very well.

Thomas Gad: Taking our achievements into consideration, we believe we have positioned Y-mAbs very well to expand our commercial activities while advancing our pipeline into cleanliness, addressing very large unmet medical needs in 2021, and we are very excited to continue to do that. And with that, I'd like to hand it over to Dr. Merlo. Thank you.

To expand our commercial activities, while advancing our pipeline and to clean it and addressing very large unmet medical needs in 'twenty and 'twenty, one and we are very excited to continue to do that and.

And with that I'd like to hand, it over to Dr. Miller. Thank you.

Thank you Thomas and thank you for everybody for and starting to true choice to spent the morning with us during the fourth quarter. We have continued to work hard to ensure that our pipeline advances to watch the market and our progress and clothing haven't gone and you also have true by the S. T. A while at the same time, making progress and the Resubmission of the Alberta might be late.

Dr. Merlo: Thank you, Thomas, and thank you, everybody, for deciding to spend the morning with us. During the fourth quarter, we have continued to work hard to ensure that our pipeline advances towards the market and our progress, including having Danielsa approved by the FDA, while at the same time making progress in the resubmission of ne-Ombertumab BLA. In addition, we have initiated a Phase II study with ne-Obertumab and small cell lung cancer under our own IND, initiated two Phase I-II studies, one in medulloblastoma and one in B7H3-positive CNS-leptomedical metastasis in adult patients and the CNS, and advanced our ongoing studies. We are also continuing to work on our new bispecific constructs and the SATA programs, as well as our TD2, CD3 vaccine.

In addition, we have initiated a phase II study with <unk> and small cell lung cancer under all 90 and.

D C. A two phase one two studies one in the total blastoma and piece and one and B seven eight street positive CNS Leptomeningeal and metastasis.

And in adult patients and the CNS and advanced our ongoing studies. We are also continuing to work on our new bi specific construct and this other programs as well as our teacher she gets re vaccine.

Next set them up on November 25th the FDA granted us the approval after any else and then he also has indicated and combination with GM CSF for the treatment of pediatric patients one year of age and older and adult patients with relapsed or refractory high risk neuroblastoma and the bone up on Mero, we'll have demonstrated a partial response.

Dr. Merlo: On November 25th, the FDA granted us the approval of Danyelsa. Danyelsa is indicated in combination with GMC-SF for the treatment of pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under the accelerated approval regulation based on overall response rate and duration of response.

Hans minor response or stable disease for price therapy. This indication is approved under accelerated approval regulations based on overall response rate and duration of response and approval came a few days in advance of the Paducah date, and we are thrilled to send out the first commercial bias to the treatment centers, including M. S K across.

Dr. Merlo: The approval came a few days in advance of the PDUFA date, and we are thrilled to send out the first commercial vials to treatment centers across the country earlier this month. So that was really a major achievement for the FDA. Let me pause for a second and acknowledge the team effort that made it possible to take this antibody from signing the MSK licensing agreement in August 2015 to becoming a commercial product on the shelf available to all applicable patients in the United States in February 2021.

The country earlier this months, so that was really and a major achievement for the team.

Let me pause for a second and acknowledged cheat and ask for it that made it possible to take this antibody from signing the M. S. K licensing agreement in August 2015 to becoming a commercial product on the shelf available to all applicable patients and the United States and stay there for I V 'twenty 'twenty, one and it.

It has been less than five and a half years in total and our employees consultants and investigators site staff and also our team deserves the highest credit for their tireless efforts and supporting it and advancing Danielle so true that development and registration.

Dr. Merlo: It has been less than five and a half years in total, and our employees, consultants, investigators, site staff, and authorities deserve the highest credit for their tireless efforts in supporting and advancing Danielsa through its development and registration.

As you know a small universe of pediatric cancer centers treat the majority of us and all of a stone that patients and we believe that we have built at lean and highly targeted commercial organization and hit us at launch.

Dr. Merlo: As you know, a small universe of pediatric cancer centers treat the majority of neuroblastoma patients, and we believe that we have built a lean and highly targeted commercial organization ahead of the launch. In addition to the approval of Danielsa, we have clinical trials ongoing with Danielsa in Barcelona and at MSK in New York for first-line oblistoma maintenance treatment, as well as chemo-combination trials for re We are working to initiate an international phase 2 multi-center trial for nuxetamib in both frontline and in chemocombination treatments.

In addition to the approved after and he also having have clinical trials ongoing with any outside and pass it on that and at M. S. K and New York for first line of the storm and maintenance treatment as well as chemo combination trials for refractory and all of US don't want patients we have.

Working through and issued eight and international Phase II multi center trial for next set them up and both frontline and in a chemo combination treatments.

We also have a phase II osteosarcoma trial ongoing at three sites and the U S.

Dr. Merlo: We also have a Phase II osteosarcoma trial ongoing at three sites in the U.S. Now, turning to Onbertumab, our second lead compound. In October, we received a refusal-to-file letter from the FDA regarding the BLA for Onbertumab for treatment of pediatric patients with CNS-leptomeningo-metastasis or neuroblastoma. Upon its preliminary review, the FDA determined that certain parts of the CMC module and the clinical module of the BLA required further detail.

And now turning to our bottom up our second lead compound and October we received a refusal to file letter from the FDA regarding the BLA for them put them out for treatment of pediatric patients with CNS steps from an England metastasis from neuroblastoma.

And its preliminary revenue the F D. A determined that certain part of the CMC module and the clinical module of the BLA for quiet for a little detail no additional non clinical data have been requested or required and it should also be noted that no additional clinical trials all recruitment of additional patients for a request at Westwood cash crested in the book.

Dr. Merlo: No additional non-clinical data have been requested or are required, and it should also be noted that no additional clinical trials or recruitment of additional patients were requested in the refusal-to-file contact. We have maintained a very close dialogue with the FDA regarding the resubmission of the Onbertumab DLA and have scheduled a type B meeting next month where we hope to reach a final agreement with the agency on the remaining details before initiating a rolling resubmission of our Onbertumab DLA.

As usual to file a context we.

We have maintained a very close dialogue with the FDA regarding the resubmission of the Amtrust and that DLA and have scheduled debt type B meeting and next months, where we hope to reach a final agreement with the agency and the remaining details before initiating a rolling submission of our BLA.

We remain confident that we can address all points raised by the FDA, including providing the requested supplementary data from study 101, which will include tumor response data from patients whether they are able to cease and then.

Dr. Merlo: We remain confident that we can address all points raised by the FDA, including providing the requested supplementary data from Study 101, which will include tumor response data from patients with a valuable disease among the patients included in the study. We expect to resubmit the Onbertumab DLA by the end of the second quarter or maybe in the beginning of the third quarter of 2021. The European marketing application for Ombertumab has been prepared in parallel with the U.S. BLA, and we plan to submit the marketing authorization application in late April of this year to EMA and begin staffing our European commercial operations within the next few months.

And the patients included in this study and we expect to resubmit, the and both of them at BLA by the end of second quarter or maybe in the beginning of third quarter 2021 and.

The European marketing application for them and burden that has been for past in parallel with the U S. BLA and we plan to submit the marketing authorization application in late April of this year too.

And to EMA and pick and staffing our European commercial operations within the next few months as previously disclosed and we have we are also developing and burden that for diffuse intrinsic pontine glioma known as D. I P D and a phase one two study at M. S. K and we are planning to open and multi center phase II study for D. I P T patients short.

Dr. Merlo: As previously disclosed, we are also developing Ombertumab for diffuse-intrinsic pontine glioma, known as DIPD, in a Phase I-II study at MSK, and we are planning to open a multi-center Phase II study for DIPD patients shortly. For desmoplastic small round cell tumors, known as DSSRCT, we have recently opened a Phase II study at MSK. Furthermore, in October last year, the FDA cleared our IND for the 177-Lutetium-Ombertamide-DTPa construct for the treatment of medulloblastoma, which is one of the most common types of primary brain tumors in children.

But there's no plastic small round cell tumors snow and ice DSS assay Chi we have recently opened a phase II study at M. S. K.

Furthermore, in October last year, the FDA cleared our IMT for the 177% lutetium and burden that teach P. A construct for the treatment of Metolachlor still net and suite is one of the most common types of primary brain tumors and children.

And 77 to teach them and both of them have D. G. P E and buddy's hour and make it and both of them up and antibody. Rachel later with lutetium 177, and using a D. G. P. A molecule true chelate lutetium radio isotopes for the antibody.

Dr. Merlo: 177-Lutetium-Ombertumab DTPA embodies our naked ombertumab antibody radiolabeled with Lutetium-177 using a DTPA molecule to chelate the Lutetium radioisotope to the antibody. Medulloblastomas are invasive, rapidly growing tumors. Unlike most brain tumors, they spread through the cerebrospinal fluid and frequently metastasize to different locations along the surface of the brain and spinal cord.

If you look at us Thomas I invasive rapidly growing tumors. Unlike most bring too much they spread through the surplus spinal fluid and frequently metastasize to different locations along the surface of the brain and spinal cord and.

And the incidence of mature stroma in the U S is approximately 350 patients per year, and we deem this to be advantageous and finding a regulatory pathway to potential approval for the lutetium labeled and Petsmart T. J P. A construct.

Dr. Merlo: The incidence of medulloblastoma in the U.S. is approximately 350 patients per year, and we deem this to be advantageous in finding our regulatory pathway to potential approval for the Lutetium-labeled ombertumab DTPA construct. We anticipate that our International Multi-Center Phase 1-2 trial will start screening patients with medulloblastoma later this quarter, and based on our clinical experience with the We are obviously excited to see 177-lutetium-ambertumab DTPA make its way to the clinic to potentially establish the safety profile and determine the maximum tolerated dose of this construct. In this study, we hope to leverage our clinical experience from treating 27 medulloblastoma patients with the iodine-131-ambertumab construct. Once again, using an indwelling catheter for the intracerebral ventricular drop delivery, also called monomia, catheter, and reservoir.

We anticipate that our international multi center phase one true trial will start screening patients with medulloblastoma later this quarter and based on our clinical experiments experience with the automated and burden that for.

For <unk>, seven and eight street.

Positive metastasize and the brain. We are obviously excited to see 177 to teach them and but that's not the G. P. Eight make its way to the clinic to potentially establish the safety profile and determine the maximum tolerated dose of this construct and this study we hope to leverage our clinical experience from treating twenty-seven matola pistol and.

Patients with the iodine once and you want them boats and that kind of strength once again using indwelling catheter for the intra sample and triple net drop delivery also called and and Miami.

Cash and vessel work.

In addition to the F D a.

Dr. Merlo: In addition to the FDA, the FDA has also recently cleared our separate IND for a basket trial in B7H3 positive CNS leptomeningocancers in adults. While we hope to leverage our prior experience treating more than 25 adults with the iodinated iodine-131 ombertumab, we expect to initiate the study for the first adult patients to be screened and treated with the 177-lutet And we are thrilled to widen our clinical reach to include these adult indications. As you also recall, we announced that the FDA has granted orphan drug designation and rare pediatric disease designation to our leading bispecific antibody, nivotrotomab, for the treatment of neuroblastoma. That happened in October 2020.

And the FDA has also recently cleared our separate and D for a basket trial and piece of and HD positive CNS lepton and equal Kansas in adult patients, where we hope to leverage our prior experience from treating more than 25 adults with the iron and aided iodine 131 or both of them are we expect to initiate the study.

For the first adult patients to be screened and treated with the 177 to teach them on both from a D. G. P. A during the first quarter of this year and we are thrilled to widen our clinical leads to include these adult indications.

Yeah.

As you also will recall, we announced that the FDA have granted orphan drug designation and rare pediatric disease designation to our leading bi specific antibody and NEVA trucks and Matt for the treatment. That's neuroblastoma that happened in October 'twenty and 'twenty.

Resubmitted and int for a phase II study and small cell lung cancer and the fourth quarter of 27 2020, and the IMT has now cleared. So we are excited to buy it and leave a trop two maps clinical reach to include add on for lung cancer patients. In addition, we plan to expand the ongoing study off for me, but try to map at M. S. K Institute.

Dr. Merlo: We submitted an IND for a Phase II study in small-cell lung cancer in the fourth quarter of 2020, and the IND has now cleared, so we are excited to widen Nivotrotumab's clinical reach to include adult lung cancer patients. In addition, we plan to expand the ongoing study of Nivotrotumab at MSK into two separate Phase II arms, one in oblistoma and one in osteosar And turning to the SATA technology, we are very excited about the prospects of this technology, and we are making good progress in preparing our SATA targets for clinical development.

Phase two arms, one and neuroblastoma and one osteosarcoma.

And turning to the Sada technology, we are very excited about the prospects for this technology and we are making good progress and preparing our SATA targets for clinical development.

And announced targets include TD to Sada for potential use and TD true positive solid tumors, such as melanoma small cell lung cancer and triple negative breast cancer. These seven H three sada, which is intended for the use of treatment and prostate cancer.

Dr. Merlo: Our announced targets include DD2 SATA for potential use in DD2-positive solid tumors such as melanoma, small cell lung cancer, triple negative breast cancer, B7H3 SATA which is intended for the use of treatment in prostate cancer, DPA-33 SATA for potential use in colorectal cancer, and HER2 SATA for potential use in breast cancer or, eventually, also gastric cancer. And these first SATA constructs; we expect to file the first IND for the DD2 SATA in the fourth quarter this year.

D P. A 73 sada for potential use in colorectal cancer and her two sada for potential use in breast cancer will eventually also gastric cancer and these first sada construct we expect to file the first IMT for for the TD true solder in the fourth quarter. This year, we believe the Sada technology can potentially improve the.

Dr. Merlo: We believe the SATA technology can potentially improve the efficacy of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents, and we are truly excited about the SATA technology. So, to sum up, with the approval of Danielsa and the launch already leading to deliveries to multiple treatment centers across the country, and the planned resubmission of the Umbertumab BLA coming up, we believe that we are well-positioned to continue the development of Y-mAbs as a commercial company.

And efficacy Radiolabel therapeutics and tumors that have not historically demonstrated meaningful responses to radio labeled eight agents and we are truly excited about this hybrid technology.

So to sum up with the approval of Fannie Elsa and the launch already leading to deliveries to move to multiple treatment centers across the country and the planned resubmission of both from a BLA coming up we believe that we are well positioned to continue the development of fly maps as a commercial stage company concurrently we plan to widen.

Dr. Merlo: Concurrently, we plan to widen and deepen our pipeline by advancing our antibody constructs through the clinic, predominantly with the SATA constructs, the bispecifics, and the. In other words, we have a lot on our plate for 2021, and we are excited to move forward and build a business that helps patients and fuels our continued development. Now, let me invite Bo to share his remarks on the 2020 financials.

And deepen our pipeline by advancing our antibody constructs true the kidney predominantly with the sada construct the bi specifics and then next generation and personal teacher created and it really it with antibodies.

In other words, we have a lot on our plate for 'twenty and 'twenty, one and we are excited to move forward and build a business that helps patients and fuse and our continued development work.

Now, let me invite Bo to share his remarks on the 2020 financials.

Thank you Klaus.

Bo Kruse: Thank you, Klaus. We reported a net loss for the full year ended December 31st, 2020, of $119.3 million, or $2.97 per share, basic and diluted, compared to a net loss of $81 million.

Reported a net loss for the full year ended December 31, 2020 of $119 $3 million for $2 and 97 per share.

Basic and diluted compared to a net loss of 81 million for $2 30 per share basic and diluted for the year ended December 31st 2019.

Bo Kruse: or $2.30 per share, basic and diluted, for the year ended December 31st, 2019. We were happy to record the first revenues in the history of Y-mAbs in 2020.

We were happy to record the first revenues and the history of Wimax and 'twenty and 'twenty.

Total net revenues of $28 million for the year ended December 31, 2020 related to our licensing arrangements and China with cyclone and Israel with Takeda.

Bo Kruse: We recorded net revenues of $20.8 million for the year ended December 31, 2020, related to our licensing arrangements in China with Cyclone and in Israel with Takeda. There were no revenues reported in the year ended December 31st, 2019. We incurred $2.2 million of royalty expense for the year ended December 31st, 2020, related to our licensing revenue. There were no such royalty expenses reported in the year ended December 31st, 2019.

There were no revenues reported in the year ended December 31 2019.

We incurred $2 $2 million and royalty expense for the year ended December 31st 2020 related to our licensing revenue and there were no such royalty expenses reporters and the year ended December 31 2019.

And we'll take a closer look at the operating expenses for the full year 'twenty and 'twenty. We note that R&D expenses have increased by $30 2 million from $63 5 million for the year ended December 31st 2019, 290, $793 7 million for the year ended.

Bo Kruse: As we take a closer look at the operating expenses for the full year 2020, we note that R&D expenses have increased by $30.2 million from $63.5 million for the year ended December 31, 2019, to $93.7 million for the year ended December 31, 2020. This increase was primarily attributable to a $13.2 million increase in milestones and license-related costs, primarily related to our acquisition of the SATA technology from MSK. And a $13.4 million increase in personnel costs, a $1.6 million increase in outsourced services and supplies, and a $1.1 million increase in professional and consulting fees.

December 31st 2020.

This increase was primarily attributable to a $13 2 million dollar increase and milestones and license related cost primarily related to our acquisition and I'll speak startup technology from S. K.

And a $13 $4 million increase and personnel costs and <unk>.

One $6 million increase and outsource services and supplies and.

And at one point and $1 billion increase in professional and consulting fees.

G&A expenses increased by $25 3 million from 19 5 million for the year ended December 31, 2019 to $44 8 million for the year ended December 31, 2020, the increased and G&A expenses, primarily restrict at $8 9 billion total increase and personnel cost 12.

Bo Kruse: DNA expenses increased by $25.3 million, from $19.5 million for the year ended December 31, 2019, to $44.8 million for the year ended December 31, 2020. The increase in DNA expenses primarily reflects an $8.9 million increase in personnel costs, $12.7 million increase in commercial expenses for our sales and marketing infrastructure related to the commercial launch of Danielsa, and a $2.1 million increase for business insurance and a $2.1 million increase for professional services. Cash used in operating activities as of December 2020 shows that the cash burn increased by $17.7 million from $73.5 million for the year ended December 31st, 2019 to $91.2 million for the year ended December 31st, 2020. The increase was primarily caused by an increase in the net loss for the period.

7 million dollar increase and commercial expenses for our sales and marketing infrastructure related to the commercial launch of Sarnia and stuff and $2.1 billion increase for business insurance and I took one 1 million total increase for professional fees.

Cash used in operating activities as per December 'twenty, and 'twenty show that the cash burn increased by $17 7 million from $73 5 million for December 31st 2019, $291 2 million for the year ended December 31st 2020.

The increase was primarily caused by the increase and the net loss for the period and it's also itself increased by $38 3 million per day December 31st two steps and in 'twenty and was partially offset by an increase in non cash expenses, including depreciation and stock based compensation of $22 million.

Bo Kruse: The net loss itself increased by $38.3 million for the year ended December 31, 2020, and was partially offset by an increase in non-cash expenses, including depreciation and stock-based compensation of $20.2 million. We ended 2020 with a cash position of $114.6 million compared with the 2019 year-end cash position of $207.1 million. As our work on the AlbertaMAP BLA resubmission has progressed through the fourth quarter, and we have continued to accelerate the commercial ramp-up for the launches of Daniosa, and AlbertaMAP is approved,

We ended 2000, and Sweeney with a cash position of $114 6 million compared with the 2019 year and cash position of $207 1 million.

And so we'll work on the Doberman BLA Resubmission has progressed from the fourth quarter and we have continued to accelerate the commercial ramp up for the launches of the new zone and a better map if it is approved.

We've seen our cash burn increase we expect the cash burn from operating expenses for 2021. So continue to remain roughly in line with the rate of the fourth quarter for 'twenty and 'twenty well Oh.

Bo Kruse: We've seen our cash burn increase. We expect the cash burn from operating expenses for 2021 to remain roughly in line with the rate of the fourth quarter of 2020, where our operating spending was in the mid-30s. In terms of financial run rate, we recently completed a secondary offering and raised a total of $115 million for the company before commission and expenses. This raise, together with the sale of the Danielse PAV at close in January, which was sold for $105 million, of which we get to keep $62 million after sharing $6040 with MSK, and our 2020 year-end cash position of $114.6 million, means that we now have an extended run rate, so This concludes the financial update, and I'll now turn the call over to Thomas.

Operating spending wasn't and image studies.

In terms of financial run rate, we recently completed a secondary offering and raised a total of 115 minutes for the company before commissions and expenses. This raised together with the sale of <unk> for close in January and was sold for $105 million, which would get to keep six 2 million after sharing 60 40 with it.

S K and our 2020 year and cash position of $114 6 million means that we now have and extended run rate. So we continue to believe why must remain in a very healthy financial position.

This concludes the financial update and I'll now turn the call over to Thomas.

Thank you very much and thank you Claus. This this marks the end of today's prepared remarks, and I'd like the operator to open up the call for questions now. Thank you.

Thomas Gad: Thank you very much, Bo, and thank you, Klaus. This marks the end of today's prepared remarks, and I'd like the operator to open up the call for questions now. Thank you.

Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

Operator: Thank you. Thank you.

Operator: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. 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 the star keys.

A confirmation tone will indicate your line is and the question queue.

You May press Star two 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 and his darkies one moment. Please while we poll for questions.

Operator: One moment, please, while we poll for questions. Thank you. Our first question comes from the line of Alec Stranahan with Bank of America. Please proceed with your question. Hey guys.

Yeah.

Thank you. Our first question comes from the line of Alec Stranahan with Bank of America. Please proceed with your question.

Hey, guys. Thanks for the questions and congrats on closing out a solid 'twenty and 'twenty.

Alec Warren Stranahan: Thanks for the questions, and congrats on closing out a solid 2020. So, first, for me, on nivotrotumab, how are you approaching the small-cell lung cancer study given the various modifications that were proposed following the results last year from the BASC-IT trial? And I guess, you know, how do you see this asset sort of slotting into the treatment paradigm for both neuroblastoma and osteosarcoma, given that Danielza may actually reach approval for these indications first?

So first for me on and do you have a roadmap and how are you approaching the small cell lung cancer study given the various modifications that were proposed falling the results last year from the basket trial and I guess I'm you know how do you see this asset sort of flooding into the treatment paradigm and both neuroblastoma and obviously.

So I called my given that Daniels.

And they actually reach approval and these indications first and that's.

Dr. Merlo: I'm not sure I understand the last part, but you can get back to that. But for the small cell lung cancer study, the idea is to take patients that are second-line small cell lung cancer patients, meaning patients that have relapsed after being treated in the front line or continue to progress. And as you for sure also know, some of the PD-1 and PD-L1s in neuro-oncology treatments are approved in second-line small cell lung cancer.

I got a follow up.

And then I'm not sure I caught the last part, but you can get back to that but for the small cell lung cancer study and the idea is to take patients that are second line non small cell lung cancer patients, meaning patients that have relapsed after being treated.

Treated and frontline all continues to progress and and then as you push you also know some of the PD one PDL ones immuno oncology treatments approved in second line small cell lung cancer and most likely the patients for the also I've seen these and potentially also additional chemotherapy before they came come onto NEVA taught them that we are giving the product and company.

Dr. Merlo: So most likely, the patients will also have seen these and potentially also additional chemotherapy before they come onto Nivotrotomab. We are giving the product in combination with corticosteroids on a weekly basis, a biweekly basis, sorry. And the idea is to give subcutaneous administration that should further reduce the side effects, potential side effects, or risk of side effects from T-cell activation systemically, cytokine release. So that was the answer to Nivotrotomab, I think. What was the other question?

And with corticosteroids on a weekly basis, a biweekly basis, sorry, and and and the idea is to keep subcutaneous administration and that should reduce further the side effects potential side effect of risk of side effects from from T cell activation systemically cytokine release. So so so that was the answer to the individuals from up I think but what's the other.

Yeah.

Yeah, and then just you know how do you see it flooding and maybe behind Daniels, our given they're going after similar indications and it's somewhere and target.

Alec Warren Stranahan: Yeah, and then just, you know, how do you see it slotting in maybe behind Danielza, given they're going after similar indications and a similar target?

Dr. Merlo: Well, we are, you can say in the neuroblastoma setting, we are treating patients in the third line that have been exposed to Danielsa, and as you can see also when you look at the data from the 201 study, we had a 68% overall response rate based on the investigators' overall evaluation, leaving 32% of the patients not responding.

Well, we are you can say and the neuroblastoma setting we are treating patients and third line that have been exposed to Daniels and and as you can see also when you look at the data from the 201 study we had a 68% oil response rate based on investigators all evaluation and leaving 72 per cent of the patients.

Not responding and.

And so that's definitely still and unmet medical need and in the.

Dr. Merlo: And so there's definitely still an unmet medical need in the nervous stoma setting, so I don't think it's going to cannibalize in any way the market for Daniosa. And as I also said, this is a very early stage study in the nervous stoma setting. So I don't think it's going to

And then open the stoma sitting so I don't I don't think it's going to cannibalize and anyway there.

Market for Danielle.

And and it's as I said also this is a very early stage study and then I'll just almost sitting so I don't think it's going to.

I think it's way too early to start discussing whether one would substitute the other one and one is a commercial product and it's on the market and available on the shelf for the other one for development program.

Dr. Merlo: I think it's way too early to start discussing whether one would substitute the other one. One is a commercial product, and it's on the market and available on the shelf. The other one is a development program that has several years ahead of it before it could potentially get BLA approval.

Several years ahead of it before it could potentially get to a BLA approval.

Okay.

Alec Warren Stranahan: Okay, that's very helpful. And one more question, if I may, on the SATA platform. Yeah.

Very helpful and one and one more question if I may I'm actually I'm the decider platform.

Yeah, you know your ability to sort of confined the radiation to the target tissue and in preclinical models is definitely encouraging but.

Alec Warren Stranahan: You know, your ability to sort of confine the radiation to the target tissue in preclinical models is definitely encouraging, but could you maybe speak to the residency time in other organs as it's excreted and what will be done in patients to manage this as the first product enters the clinical industry?

Could you maybe speak to the residency time and other Oregon as its excrete it and what will be done and patient to manage this and that's the first product and theirs.

And clinically for this year.

Dr. Merlo: Yeah, the actual construct, per se, is, of course, not a problem because it's not toxic in any way. So, and, of course, if there is normal tissue expression of the target the tumor-binding part of the construct is binding to, then you may have some normal tissue binding of the construct. The first one is for TD2, and we don't think that there's an issue with the doses that we are working on in terms of side effect profiles from TD2 binding to eventual nerve fibers.

Yeah. The actual contract per se is of course, not a problem because it's not toxic and anyway, so and and of course, if there is normal tissue expression of the target that you want finding product and the construct is binding to and then you may have some normal tissue binding us off the construct the first one is for TD true and and and we don't think that there's an issue with the doses that we work.

And in terms of side effect for classroom that you'd get to binding to the eventual nerve fibers and we are definitely not concerned about the radiation and since we know that at M. S. K. They have given up to a very high doses of radio labeled T to chew and she bought it for patients in the past so software that are substantially higher than the doses, we expect to use with the sada.

Dr. Merlo: And we are definitely not concerned about the radiation since we know that at MSK, they have given up to very high doses of radiolabeled TD2 antibody to patients in the past, so those are substantially higher than the doses we expect to use with the SATA. So then when we shoot in the DOTA molecules with lutetium-177 that's supposed to bind to the DOTA end of the SATA construct that's bound to the tumor, then you can say, but what about normal tissue toxicity from the DOTA molecules with lutetium caged in the molecule?

So then when we shoot and the total molecules with their do teach them 177, net as opposed to bind to the data and that's the true them up off of the Sada construct that's bound to the tumor and then you can say, but what about normal tissue toxicity from the total molecules with lutetium cases, and the in the molecule and and that's a very tiny little molecule.

Dr. Merlo: And that's a very tiny little molecule, so of course, it's going to spread to the entire water phase of the patient's body, which is typically 70% of an adult male and a bit less for an adult woman. But the thing is that this DOTA molecule will pass through the kidneys in circulation, and every time it passes through, half of it is going to leave the body through the kidneys and into the bladder.

And so so of course, it's kind of spread for the entire water finish up the patient's body, which is typically 70% up and that all the mail and and a bit less for an adult woman and.

But the thing is that that debt. This dota molecule with posture with the kidneys and circulation and everytime. It passes through half of it is going to leap and the body true the kidneys and into the bladder now bladder radiation is of course, not very comfortable and you make it a radiation for status and Atlanta from the plateau. If you don't put in a cast and make sure you continue.

Dr. Merlo: Now bladder radiation is, of course, not very comfortable, and you may get radiation cystitis in the bladder from the radiation if you don't put in a castor and make sure you continuously drain the bladder while the patient is having the circulating DOTA radiation construct in there. But I think that's... That's my only real clinical topic to focus on in terms of toxicity, and in the pre-IND discussions we have had with the agency, they don't seem to be utterly concerned about that side of it either, so we are quite comfortable that we will be able to move this into the clinic in the fourth quarter of this year.

Mostly trained and bladder while the patient is having the circulating dota radiation construct and there, but I think that's it.

And that's my only real clinical and topic to focus on in terms of toxicity and and and and the the pre IND discussions we've had for the agency. They don't seem to be utterly concerned about that side of it either so so we are quite comfortable that we will be able to move this towards the clinic in the fourth quarter of this year.

Alec Warren Stranahan: Perfect. Thank you. And congrats again on the progress.

Per.

Thank you and congrats again on the progress.

Thank you very much and I think.

Thomas Gad: Thank you very much, Alec.

Our next question comes from the line of Robert Burns with H C. Wainwright. Please proceed with your question.

Operator: Our next question comes from the line by Robert Burns with H.C. Wainwright. Please proceed with your question.

Hi, guys. Thanks for taking my questions and congrats on the quarter just a few from me if I may. So my first question is around the Alberta memory submission and I just wanted to get a sense well it remains to be done with completing the resubmission package to the FDA and with regard to the type B meeting does why not been turned on issuing a press release on the results for that meeting. So that's my first one.

Robert John Burns: Hi guys, thanks for taking my questions, and congrats on the quarter.

Dr. Merlo: Just a few from me, if I may. So my first question is around the Invertebrate Resubmission. I just wanted to get a sense of what remains to be done with completing the resubmission package for the FDA. And with regard to the Type V meeting, does YMAB intend on issuing a press release on the results of that meeting? That's my first one.

Okay, Yeah, well I mean, we are putting together all the data we have one of the things that happened in December where there was a new paper published by <unk> and the European and pediatric oncology organization.

Dr. Merlo: Okay, yeah, well, I mean, we're putting together all the data we have. One of the things that happened in December was there was a new paper published by Styrofoam, the European Pediatric Oncology Organization, where they gave data from 63 patients with CNS, lepto-meningo-noblistoma relapse, and shared all the survival data that is precisely as rotten and poor as The good thing here is that there are some more granularity and details from that database than was available initially from the Central German Cancer Register database.

They gave data from 63 patients with CNS, let somebody I don't know if the stomach.

And relapse and and she at all and survival data that is precisely this run and and for US as for all the other studies that has been published the good thing here is that there are some more granularity and details from that database than there was available initially from the central German canceled registered database. So now we have to see.

That's a historical control we have worked with my opinion January to make sure and agree with them that they would give us access to debt to the data from that.

Dr. Merlo: So now we have two sets of historical controls. We worked with Zyrapen in January to make sure and agree with them that they would give us access to the data from that study, and we have gotten access to that, which the FDA seems to be very happy about. So now we have used that data set also as a second search historical control panel.

Ah study and and we have gotten access to that which the FDA seems to be very happy about and so now we have used net dataset and second a.

So its historical control panel. So so that has been has been put together and and submitted to the FDA and preparation for the type B meeting at the end of the next months.

Dr. Merlo: So that has been put together and submitted to the FDA in preparation for the type B meeting at the end of next month. And then, in terms of when we have had that meeting, and we receive the minutes from the meeting, that typically happens... eight to fourteen days after the meeting. Then, of course, we will come and guide you on what the outcome of the meeting was and what we expect that to mean in terms of resubmission. Okay, awesome.

And then in total.

And what when we have had that meeting and we received the minutes from the meeting that typically happens and stuff.

8% to 14 days after the meeting there and of course, we will come in and guide what the outcome for the meeting was and and what we expect that to me and in terms of the Resubmission.

Okay awesome. Thanks Klaus.

My second question. So could you provide any additional color around the trial design for Daniels and the frontline neuroblastoma setting that's slated to begin this year for instance, I assume it's going to be a non inferiority trial against Daniels, though with event free survival being the primary endpoint, but are you.

Robert John Burns: Thanks, Klaus. My second question, so could you provide any additional color around the trial design for Danielza in the frontline neuroblastoma setting that's slated to begin this year? For instance, I assume it's gonna be a non-inferiority trial against Danielza with event-free survival being the primary endpoint, but are you writing into the protocol the exclusion of ASCT in the noxidimab arm explicitly

Are you writing into the protocol the exclusion of a S. C T and then knocks it and my arm explicitly.

No were not because of you know.

Uh huh.

And if patients have received bone marrow transplant, then they can come and still but we're not requiring the bone marrow transplant and and as you have also seen previously when Dr. Morris treating patients he doesn't give them bone marrow transplant and the frontline setting.

Dr. Merlo: No, we're not because, you know, if patients have received bone marrow transplants... then they can come in still, but we're not requiring the bone marrow transplant. And as you have also seen previously, when Dr. Moore is treating patients, he doesn't give them bone marrow transplants in the frontline setting. So it's not, but we will put into the analysis section of the protocol that we will do separate analysis of the patients with bone marrow and those without bone marrow.

So it's not I thought people putting for the analysis section of the protocol that we would do a separate analysis of the patients will go and Maryland without for them now.

Okay.

And considering the totality of the data seen to date for Daniels and neuroblastoma, and what time point and do you believe you could potentially go to the F D. A with some interim data.

And potentially request accelerated approval and the frontline setting.

It's a little too early for us to say, but I am hoping and the second half of this year that we can have a.

Type B meeting with the FDA to discuss this we still have a breakthrough designation for this construct and nobody stole myself. So we are eligible for additional meetings and you know as you may recall, we had the 59 patients frontline study that was recently completed full enrollment at M escape and as soon as we have collected the data from that study.

Dr. Merlo: Okay. And considering the totality of the data seen to date for Danielle's and neuroblastoma, at what time point do you believe you could potentially go to the FDA with some interim data to potentially request accelerated approval in the frontline setting?

The most likely putting that together with the data set from comes off Tomorrow study and asking for a type B meeting.

Dr. Merlo: It's a little too early for us to say, but I am hoping in the second half of this year that we can have a type B meeting with the FDA to discuss this. We still have a breakthrough designation for this construct in the opostoma, so we are eligible for additional meetings. And you know, as you may recall, we had the 59 patients in the front line study that was recently completed at MSK, and as soon as we have collected the data from that study, we would be most likely putting that together with the data sets from Dr. Moore's study and asking for a type B meeting. But I can see already now that some of the patients that we are treating are patients that are actually in the front line. So, and as I said before, I mean.

But I see let me now some of the patients that debt. We are treating our patients that are that are actually and.

And frontline.

So it was really and.

And as I've said before I mean.

Debt definitely idea and M. S. K, they would I mean why would they.

Not continued to treat patients and frontline, but and that set them out and so, but but but it's not an approved indication yet and we are pursuing debt.

No that makes complete sense. Thank you so much cost and congrats again on the quarter.

Thank you very much take care of them.

Our next question comes from the line of Ed surgery.

Please proceed with your question.

Hi, This is Paul on for Ed Thanks for taking a question.

And for Daniels are hoping to get some additional comments on how you anticipate for launch trajectory to shape out in the coming months and maybe in context of the current Covid dynamics and also you've recently partnered with licensing and distribution partners and China, Israel Eastern Europe, and can you help us understand the opportunity for Daniels and and burden that indeed.

Robert John Burns: Definitely at MSK, they would, I mean, why would they not continue to treat patients in the front line with eczema, but it's not an approved indication yet, and we are, of course, pursuing that.

Dr. Merlo: No, that makes complete sense. Thank you so much, Klaus, and congrats again on the quarter.

Particular regions and how after the patients might book Thanks.

Robert John Burns: Thank you very much. Take care, Rob.

Operator: Our next question comes from a line by Etzer Darout with Guggenheim. Please proceed with your question. Hi, this is Paul Long from Etzer. Thanks for taking our question. For Danielza, hoping to get some additional comments on how you anticipate the launch trajectory to shape out in the coming months, maybe in context of current COVID dynamics, and also, you've recently partnered with, you know, license and distribution partners in China, Israel, and Eastern Europe. Can you help us understand the opportunity for Danielza and Invertimab in these particular regions and how applications might look? Thanks.

Yeah in terms of commenting on the launch and I can only say that I mean, we will of course report and the first quarter sales when we get to our first quarter reporting.

I'm happy to see that that would be have been able to ship to a number of sites outside of and MS. Kay also.

M S K minutes to just shortly ahead of the.

Two next hospitals to come in and and placed the first order, but what we have seen a very positive.

Lying to whats accepting the day they use it for next year and exit them up so so very comfortable with the way. This has panned out and in the first three to four weeks looking very much for what you report on the quarter. When we have all our first quarter conference call in terms of partnering obviously the most interesting part here is the Chinese partnering because China.

Thomas Gad: Yeah, in terms of commenting on the launch, I can only say that, I mean, we will, of course, report on the first quarter sales when we get to our first quarter reporting. I'm happy to see that we have been able to shift to a number of sites outside of MSK also, but MSK managed to just shortly ahead of the two next hospitals to come in and place the first order, but we have seen a very positive line towards accepting the use of Nexidermab. So I am very comfortable with the way this has panned out in the first three to four weeks.

Well hopefully grant us approval based on the pre BLA package, so we have submitted and and China too.

And to file for approval with our BLA package, primarily consisting of what we filed for the F. D. A.

And and if that's the case, then hopefully and third quarter. This year, we can submit the Chinese DLA for and exit them at.

Thomas Gad: I am looking very much forward to reporting on the quarter when we have our first quarter conference call. In terms of partnering, obviously, the most interesting part here is the Chinese partnering because China will hopefully grant us approval based on the pre-BLA package we have submitted in China to file for approval with a BLA package primarily consisting of what we filed for to the FDA. And if that's the case, then hopefully, in the third quarter this year, we can submit the Chinese BLA for Nexidermab. And then what will be the size of the market? As we speak now, there are about 2,000 Chinese patients that each year receive the diagnosis of neuroblastoma, and there's very limited treatment available for them.

And and then what is the size of the market.

As we speak now that's about 2000 Chinese patients that each year and received a diagnosis of and all of us doing that.

And that's very limited treatment available for these patients.

Now pricing wise, I mean, you're probably not going to be able to get more than 15% to 20% of the U S price.

But with the market that is three fold as big as the U S market is still a very interesting market also from a financing perspective.

In terms of Israel, Israel is a very small country, but they also do have quite a bit of medical tourism.

I mean, it it's it's a I don't think you'll be able to see that the sales and Israel hopefully I hope you can see the sales and Israel.

Thomas Gad: Now, pricing-wise, I mean, we're probably not going to be able to get more than 15 to 20 percent of the U.S. price. But with a market that's threefold as big as the U.S. market, it's still a very interesting market, also from a financial perspective. In terms of Israel, Israel is a very small country, but they also do have quite a bit of medical tourism. I mean, it It's I don't think you'll be able to see the sales in Israel, hopefully.

Anything else by the blip on our financials.

Now the collaboration and distribution agreement with snakes is addressing a relatively sizable market in particular, there is and in Russia, new system set up where well there's allocated a significant amount of hundreds of millions of euro true two pediatric oncology treatments and we off course pursue.

Thomas Gad: I hope you can't see the sales in Israel as anything else but a blip on our financials. Now, the collaboration and distribution agreement with Swix is addressing a relatively sizable market, and in particular, there is a new system set up in Russia where a significant amount of hundreds of millions of euros are allocated to pediatric oncology treatments, and we are, of course, pursuing to try to get under that program.

And to try to get under that program.

Did that answer your question and sensor.

That's perfect that's very helpful. Thanks, so much.

Our next question comes from the line of David Lebowitz with Morgan Stanley. Please proceed with your question.

Thomas Gad: Did that answer your question, Tessa? That's perfect. That's very helpful.

Thank you very much for taking my question you were talking earlier about the IMD.

Tessa Thomas Romero: That's perfect. That's very helpful. Thanks so much. Our next question comes from David Leibowitz with Morgan Stanley. Please proceed with your question. Thank you very much for taking the time.

Filed for.

And Berta Mab targeting <unk>, seven and eight three for adult indications and that was just.

I was a little confused.

David Matthew Nierengarten: You were talking earlier about the IND filed for Umbrtomab targeting B7H3 for adult indications, and I was just... I was a little confused because you initially had mentioned IA-Invertemab, and then you transitioned to LU-Invertemab. Could you just run through that again, the nature of IA-Invertemab?

When you initially had mentioned I am Berta Mab and then your transition to the.

And the Oh.

Matt could you just run through that again.

The nature and.

And what that what that trial is going yeah. Yeah. So the thing is that debt, if we're going to address adults and and as I said, we have 3% to 25 adult patients with the IR day Natus portion of the antibody.

Dr. Merlo: So the thing is that if we are going to address adults, and as I said, we have treated 25 adult patients with the iodinated version of the antibody, we needed a more, you can say, easy, quick way of being able to radio-label the ambertumab construct. And therefore, we put a DTPA chelator on the antibody. So instead of having to put the antibody on a column, iodinate, wash, and elute, and then we have to recheck the binding because some of the tyrosine sites the iodine binds to are sitting close to the antigen-determining side of the antibody. The whole process ends up taking between 60 and 100 minutes.

And we needed a more you can say easy and quick way of being able to a.

Radio labeled and both of them up construct and therefore, we put a D. G. P. A T later on the antibody.

So instead of having to put the antibody on a column and hired and aid and wash and elevate and then we have to recheck, the binding and cause some of the tires and size the IAG and buying stores sitting close to the NTT and determining side of the antibody.

The whole process ends up taking between 60 and and 100 minutes.

Well for a construct like the and both of them are P. G. P. A the only thing I need to do is to pipe had off the amount of radioactive lutetium. So it takes me 10 seconds to radio labeled antibody.

Dr. Merlo: Well, for a construct like the amberum at DTPA, the only thing I need to do is to pipette off the amount of radioactive lutetium. So it takes me 10 seconds to radio-label the antibody because the isotope will bind only to DTPA and nowhere else. And you titrate so you don't put an excess amount of lutetium, so everything will be bound to the antibody. So that's why we created that to be able to address the tens of thousands of adult patients that every year die from CNS leptin and encylmetastases that are B7H3 positive.

Does the isotope will bind only on D C P eight and nowhere.

And and and and.

Titrate. So you don't put excess amount of lutetium, so everything will be bound to the antibody. So so that's why we created that to be able to address the tens of thousands of adult patients that every year the ice from CNS lipson and ankle metastasis that that'd be seven H Street positive.

And that's why we opened a separate and for that because now we have changed the isotope and we may be able to get higher than the 50 military afraid you actually of Iot and that would be put into the hits of the kits and and people are used for debt for the 25 adults we have treated with the existing and boat and my construct and they'd be able to get up so maybe 80 or maybe even 100 and really Korea.

Dr. Merlo: And that's why we opened a separate IND for that, because now we've changed the isotope, and we may be able to get higher than the 50 milligrams of radioactive iodine that we put into the heads of the kids and that we've also used for the 25 adults we have treated with the existing ombudamap construct. We may be able to get up to maybe 80 or maybe even 100 milligrams per dose that we put into the CNS of the patients. Making it clear?

Those that we put into the CNS applications.

What's that.

Making it clear.

Is there any I guess reason why are the efficacy would be different and adults than it would be and pediatric patients.

David Matthew Nierengarten: Is there any, I guess, reason why the efficacy would be different in adults than it would be in pediatric patients?

I think that the only reason why it would be more efficacious as if we can get the radiation and up to a higher dose level and.

Dr. Merlo: I think the only reason why it would be more efficacious is if we can get the radiation up to a higher dose level in adult patients. But it's simply the key reason for going, since we are going after adult patients anyway and we have to start with a phase I, II dose escalation study anyway, rather than staying with the iodinated version, we felt that it was a relatively short delay to go for DTPA conjugation and Lutetium-177 labeling of the antibody constructs. So the antibody binds exactly like the existing antibody; it's just radiolabeled with a different isotope, and it's much faster, and easier, and cheaper to radiolabel.

And in Indiana for patients, but it it's simply that the key reason for going since we're going after adult patients anyway, and we have to start with the phase one dose escalation study anyway, rather and staying with the Io Tonight, and where should be felt that it was a relatively short delay to go for a D. G P a conjugation and to teach and why.

77 labeling of the antibody construct so the antibody binds exactly as the existing antibody. It's just radio labeled with a different isotopes and it's much faster and easier and cheaper to radiolabel.

David Matthew Nierengarten: Thank you for that. I guess the other question is, with respect to the upcoming FDA meeting, it sounds like you have the boxes checked off for the most part. Is there a possibility that you could come out of this meeting with more boxes that you need to check?

Thank you for that.

I guess the other question is with respect to the upcoming FDA meeting and it sounds like you have the <unk>.

Boxes checked off for the most part.

I guess.

Is there a possibility that you could come out of this meeting with more boxes, you need to check.

Yeah.

What's your experience with the FDA and such topics.

Dr. Merlo: What's your experience with the FDA on such topics?

[laughter] I mean.

David Matthew Nierengarten: [inaudible]

Dr. Merlo: I mean, you never know. I cross my fingers and hope that they see it as we see it, that these kids need this treatment, and they need to get it approved for them as quickly as possible. So I certainly hope that they are not coming up with new boxes that we need to check, and if they do, that it will be post-marketing commitments, and they will just give us an accelerated approval based on the tumor responses that we have seen among the first 24 patients.

And I don't know I Cross my fingers and hope that they see it as we see it that these kids need this treatment and they need to get it approved for them as quickly as possible.

And I, certainly hope that that they're not coming up with new boxes that we need to check and if they do that and it will be post marketing commitments and they will just give us an accelerated approval based on the tumor responses that'd be a seat and among the first 20 for patients.

David Matthew Nierengarten: Thank you for that.

Thank you for that.

Tessa Thomas Romero: Thanks, David.

Thanks, David.

Operator: As a reminder, if you would like to ask a question, press star 1 on your telephone keypad. Our next question comes from the line of Tessa Romero with J.P. Morgan. Please proceed with your question. Yeah, hey guys, how are you?

As a reminder, and he would like to ask a question press star one on your telephone keypad.

Our next question comes from the line of Tessa Romero with Jpmorgan. Please proceed with your question.

Yeah, Hey, guys. How are you. Thanks for taking the question and just a quick one for me as we're thinking about the launch for Daniels and I think you noted you started delivering.

Tessa Thomas Romero: Thanks for taking the question. Just a quick one from me as we're thinking about the launch for Danielle, that I think you noted you started delivering the product beginning in February. I guess, can you give us a little bit more of your sense on what metrics you'll be providing with STREET to gauge the health of the launch? Is there anything beyond kind of sales and the top line that we should be thinking about?

Beginning in February.

Yes.

You gave us a little bit more and heavier.

Have your sense on what metrics, you'll be providing the street.

And that the house and for launch and.

Is there anything beyond.

Sales top line that we should be thinking about.

I think.

Thomas Gad: I think it's too early to say what we will actually be able to provide you with, but I would be surprised if we were not able to give you a bit of guidance on how many different centers we have when we get the first quarter results. Of course, the total number of vials that we have sold and total sales and probably also the total number of sites that have started using Dernialza for treating patients.

It's too early to say, what we will actually be able to provide you with but I wouldn't be surprised if we were not able to give you a bit of guidance on how many different centers that would be when we get for first quarter results.

Of course total number of vials that we have sold and and and total sales and and probably also a.

The total number of sites that have started using danielle so for treating patients.

But I think that's as I said, we are very early on and be a few weeks into the first sites, receiving the buyouts and and.

Thomas Gad: But I think that's, as I said, we are very early on. We are a few weeks into the first sites receiving the vials and, fortunately, also a few weeks into the first successful treatments outside of MSK. So we are very excited and very happy with what we have managed to get, Danielle said, but it's a little early to give more details on the launch. That's pretty much what you were expecting to hear, Tessa.

And Unfortunately also a few weeks into that for a successful treatments outside of that Miss queso. So we're very excited and very happy with where we have managed to get done. He also but it's a little early to give more detail of Sunday lunch.

What's that.

Recently, what are you expecting to hear [laughter], Yeah, no no. That's that's helpful. It sounds like there'll be some color.

Tessa Thomas Romero: Yeah, no, no, that's helpful. It sounds like there'll be some color beyond sales, which would be helpful. And I guess my second question is a bit broader. You guys have a lot of trial initiations coming up this year, along with your ongoing studies. It would be helpful if you could sort of walk us through what data flow we should be expecting for the balance of the year, kind of for the key assets, for the key programs.

And beyond channels, which would be helpful and I guess my second question is it debt.

And you guys have a lot of trial initiation and coming up here and to hear you.

Along with your ongoing studies it would be helpful. If you could sort of walk us through what data flow, we should be expecting for the balance of the year and kind of for the key kind of key assets for the key programs.

Dr. Merlo: Yeah, I mean, of course, if you look at Nexidermab, we will be providing updates, of course, on additional submissions like the Chinese submission and the initiation of the two additional studies we're planning to start this year. And hopefully, we should also see some data when we get to PSYOP from the osteosarcoma study with Nexidermab. In terms of Ombertumab, of course, the resubmission to the FDA of the Ombertumab BLA here in the second quarter, hopefully. We are still cautiously guiding that it could slip into the third quarter, but my personal objective is definitely to get it done in the second quarter.

So.

Yeah.

Yeah I mean.

Of course, if if if you look at the next set them up.

We will be providing updates of course on the additional submissions and like the Chinese submission and the initiation of the two studies. We are planning to start this year and hopefully we should also see some data when we get to sign up from the Osteosarcoma study with NEC set them up.

In terms of burn them up of course, the resubmission to the F. D E F and Bud who might be early here in the and and in the second quarter. Hopefully we are still cautiously guiding that it could slip into the third quarter, but my personal objective is death and that just to get it done and the second quarter and the submission to EMA.

Dr. Merlo: And the submission to EMA on April 30th would clearly also be one of the key things that we would be looking for. The other things with Ombertumab would be, of course, the initiation of the multicenter DIPD study and, hopefully, also being able at ASCO to report on the progress of the DIPD Phase 1-2 study at MSK. We are hoping to get an acceptance for publication there. And then, of course, Nivotrotumab, we hopefully will be able to give some updates towards the end of the year at our usual R&D day in December on the status of the small cell lung cancer study and the status of the MSK study with Nivotrotumab. Then there's the second bispecific antibody, the CD33, and CD3.

And on April 30th with fairly also be what else. They are key things that we would be looking for and the other things with a bottom up would be of course, the initiation of the multi center study and and hopefully also being able at ask her to report on the ongoing E. D. I P T phase one twos.

And he had M S K.

We are hoping to get and acceptance of our publications that and and then of course, the and neither touch them at and hopefully we'll be able to give some update to us and it's a year at our usual R&D day in December on the status for the esports for lung cancer study and the status for the M. S. K.

Study when you were talking about and then there's the second Bispecific antibody and the CD 33 city tree.

Dr. Merlo: And hopefully, we can announce that we have gotten approval to start the AML pediatric oncology study with the CD33, CD3 bispecific in the second quarter. And then, I think, one of my real high hopes is that we manage to get this first starter construct into the clinic in the fourth quarter of this year, hopefully in the beginning. But we'll see what happens when we file the IND and get all the stuff together.

And hopefully we can and Alex that we have gotten a and approval true stopped their AML pediatric oncology study with a C. D said, hey, Tracy Detroit by specific and the second quarter.

And then I think one of my real.

High hopes is that we managed to get this for a sada construct into the clinic and in the first and fourth quarter. This year.

Hopefully and the pooling, but but let's see what happens when we file the IMT and and get all this stuff together, there's always some challenges when you start with a new type of molecules on the CMC side and took it and manufacture it and purify it the right way and and but I think we've come a long way and I think right now is.

Dr. Merlo: There are always some challenges when you start with a new type of molecule on the CMC side and get it manufactured and purified the right way. But I think we have come a long way, and I think right now, as we speak, I have 20 grams of rock available on the shelf to conduct the toxicology studies that we need in preparation for the IND filing. Was that kind of giving you a nice overview?

And we speak I have 20 grams of AV block available on the shelf to conduct the <unk>.

And the Tox studies, that'd be neat and preparation for the IND filing.

Was that kind of giving you a nice overview.

Absolutely and that was by always great. Thanks, so much.

Tessa Thomas Romero: Absolutely. That was great. Thanks so much, and thanks for taking our questions.

Thanks for taking our questions.

Operator: Absolutely. Have a good day, Tessa.

Absolutely they have a good day Tessa.

Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question.

Peter Lawson: Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question. Thanks for taking the questions and congrats on the initial shipments. Can you perhaps give us any finer detail around the number of sites that are going out beyond MSK and any kind of initial feedback you're getting from physicians about the use of the product? Anything that surprised you, either on the positive or negative side of things?

Hey, thanks.

Thanks for taking the questions and congrats on the from the initial shipments.

And you kind of perhaps give us any further detail around the number of sites that's coming out to buildings.

M M S K and any kind of initial feedback you're getting from physicians about use of the product.

And anything that surprised you either on the positive or negative side of things.

Thomas Gad: I will give you more details when we report from the first quarter about the number of sites, et cetera. The only thing I can give in color is that I'm positively surprised that there have been absolutely no issues administering the product at sites that have never tried it before. But we also have a very strong team of research nurses and MSLs and back office support that can help the sites and make sure that they are properly trained and prepared for administering the first dose.

I will give you more details when we report from the first quarter about number of sites et cetera.

The only thing I can give color is that I'm positively surprised that there has been absolutely no.

Issues administering the product that sidestep and never have tried it before but we also have a very strong team of research nurses and myself and.

And and back office support that can help the sites and make sure that they are properly trained and prepared for administering the first doses.

Is that okay, Peter Yeah, no that debt that's great.

Peter Lawson: Was that okay, Peter?

Thomas Gad: Yeah, no, that's great to hear that you're not getting cut off, issues around the drug. Like, when we see one cue, it would be predominantly MSK, or is it kind of indicating to you from the initial shipments that it's clearly breaking out of just MSK?

Great to hear that you look at it and kind of.

Issues relative.

Drug.

Is that do you think.

Like when we see one Q it will be predominantly.

M S K or is it kind of indicating to you from the initial shipments that it's it's clearly break it out just M. S K.

Peter Lawson: I hope the trend continues, and then it will mean that it's breaking out from MSK, but let's wait and see.

I hope that trend continues and then it means that it's breaking out from SK, but but let's wait and see.

Thomas Gad: Thank you. And then, just for the resubmission of InverteMAT, what could be the potential outcomes there? What are the range of outcomes from the type B meeting and associated refilings? You know, they want more data, they want a post-marketing commitment, if you kind of run through the...

Great. Thank you and then just.

For the.

Resubmission and Beth.

What could be the potential outcomes, there and what are the range of outcomes from the type B meeting and associated kind of finally re filings.

But they want more data they want to postpone and commitment if you kind of run the true.

Yeah as I previously indicated the FDA had two issues with the with the for shoes to file and one was that they felt that the historical control group did not have sufficient granularity and they've wanted that propensity score analysis.

Dr. Merlo: As I previously indicated, the FDA had two issues with the Refuse to File. One was that they felt that the historical control group did not have sufficient granularity, and they wanted a propensity score analysis on the patients, which requires you to have more granularity of the individual patients and their previous treatment. We initially thought that would not be possible with the Central German Cancer Register database. However, in between, they have actually done a tremendous amount of collaborative work for us.

And on the patients, which requires you to have a more granularity of the individual patients and their previous treatments.

And we initially saw that would not be possible with the central German cancer registered database in between they have actually done a tremendous amount of collaborative work for us.

Peter Lawson: And Germany provided us with way more details than we had hoped they would be able to. And as I also mentioned earlier, unfortunately, there was this new study from Siropin that came out in December as a publication where they granted us access to that database, including very granular datasets from the patients in that study. So I think we can address the FDA's wish for additional granularity on the control group data for historical control.

And Germany, you had provided us with way more details and we had hoped they would be able to.

And as I also mentioned earlier. Unfortunately, there was this new study from sign up and that came out in December as a publication, where they have granted us access to that database, including very granular data sets from the patients and that study. So I think we can address the fda's from wished for additional granularity on the <unk>.

Troll group data and for historical control.

Peter Lawson: Should that not be the case, they have the other possibility to say, but on the other hand, now you have 24 patients with a 6-month follow-up, full data sets, including 10 patients with tumor response data from the one-on-one multi-center study. What we could do is to call the historical data, the MSK study, historical supportive data for an approval based on a tumor response rate of 40% in your one-on-one study. And then we would give you a post-marketing commitment to provide additional oral and progression-free survival.

Should that not be the case they have the other possibility to say, but on the other hand now you have.

20 for patients for six months follow up full datasets, including 10 patients with tumor response data.

From the one and one multi center study what we could do is to call. The historical data and the Emma's case study historical supportive data for an approval based on net.

Tumor response rate of 40 per cent and you are one and one study and then we would give you a post marketing commitment to provide additional low oil and progression free survival, but but that's kind of like the two pass they have to follow and and we are.

Peter Lawson: And that's kind of like the two paths they have to follow. And we are suggesting that they continue with the original path where they now have more granularity. The multi-center study is supportive, as well as the tumor response data, and the new data on patients from the SIROPIN study together with the additional granularity from the German cancer register should be sufficient to support it. Is that clear?

Suggesting that they continue with the original Pas for that and I'll have more granularity. The multi center study is supportive and and as well as the tumor response data are supportive and the new data.

Trolls patients from the so I hope and study together with the additional granularity from the German cancer Register should be sufficient to support this.

And does that clear yeah.

Yeah.

Dr. Merlo: Yeah, no, that's definitely helpful. And then just around kind of the OPEX, how should we be thinking about that? I think you mentioned that the cash burn in 21 remains, what, in line with 4Q?

Definitely helpful. And then just around kind of the Opex, how should we be thinking, though and I think you mentioned that the cash burn and 21 remains in line with for Q.

Peter Lawson: Yeah, yeah, roughly in line with what we were spending in the fourth few, so mid-thirties, maybe a little bit lower per quarter.

Yeah.

Yeah, Yeah, roughly in line with what we were spending and in the fourth Q, So mid thirties, maybe a little bit lower per quarter and.

Does that account for the like the voucher sales.

Bo Kruse: And does that account for the like the voucher sales?

No no that's the operating cash burn so any income would be deducted from debt to get to a soda for and net level gotcha.

Peter Lawson: No, no, that's the operating cash balance. So any income would be deducted from that to get to sort of a net value.

Peter Lawson: Thank you so much. Our next question comes from the line of Sebastiaan van der Schoot with Kempen & Company. Please proceed with your question. Hi Klaus, hi guys, congratulations on the full year results for 2020.

Gotcha Okay.

Partnerships and know about shifts included and that spending right. Thank you. So there's kind of a clean room, but thank you so much.

Our next question comes from the line of Sebastian and vendor shoes with camping and company. Please proceed with your question.

Hi, Charles Hi, guys congratulations from Oh.

Full year results for 2020.

And just two questions. The first one is oh and boots them up Oh.

Operator: I just have two questions. The first one is about building up adult brain metastasis. You mentioned that you have previous experience with the iodine version. I was wondering what the chemical responses were to that particular agent in those patients.

And brain. This you mentioned that you are for previous experience with the.

I would I'm fishing I was wondering what the clinical responses were in depth with.

The particular.

Particular agent and in those patients.

Sebastiaan van der Schoot: In the medulloblastoma patients, we have had a number of patients that seem to stay in remission. Again, this is given on top of a standard regimen, including craniospinal radiation and induction chemo, and for some of the patients, even some surgery. But it is clearly our opinion, and also the investigators at MSK, that this is contributing significantly to keeping these kids in remission. Unfortunately, we will not be able to put everybody into remission like and lasting remissions as it is for the noblestoma, but if we can get to a 50% response for long-term survivors in these patients, we have made a huge leap forward for these patients. But there has been very limited publication. Dr. Kramer presented a little bit at the SIOP in 2019. There was a presentation, but it was primarily safety data.

And in the material weakness from our patients.

We've had a number of patients that seem to stay information again. This is given on the top up for standard regimen, including cranial spinal radiation and induction chemo and for some of the patients even some surgery.

But but but it is clearly the oh opinion and also the investigators is M. S. K that debt. This is contributing significantly to keeping these kids and and relations unfortunate and maybe it will not be able to put everybody into remission like and lasting remissions like it is for the stomach, but if we can get to a 50% response.

Long term survivors situation.

Situations and these patients when you have made a huge need for what for these patients.

But there has been very limited okay.

Dr Kramer percentage, a little bit and at I'm, sorry, up and 2019 and there was a presentation, but it's primarily safety data.

Okay.

And that was for the adult population and you were talking about them.

Dr. Merlo: And that was for the adult population you were talking about.

The same for the adults 25 patients and there's limited information available.

Dr. Merlo: The same for the adult 25 patients; there's limited information available, but there have been a number of patients that have responded positively. I, in particular, recall an ovarian cancer patient that had 14 metastases in the brain that all of them shrunk or disappeared after the first cycle with umbilicumab, in spite of being treatment-resistant to everything else that she had been receiving, and she lived for another 18 months. You normally don't live for 18 months with 14 brain mets from any cancer.

But there has been a number of patients that have responded positively.

And particular recall, a ovarian cancer patients that had 14 metastasis and the brain dead at all of them shrinking or disappearing after the first cycle with them both for that and.

Part of being treatment persistent to everything else that she had been receiving and she lived for another 18 months.

And they don't live for 18 months, where the 14th brain Mets from any cancer.

Dr. Merlo: Great, thank you. And then, regarding maxitumab and osteosarcoma, I was wondering if you could comment on when we could expect a complete data set for that trial and whether that would be enough, you think, for accelerated approval in the future. Yeah, as I said at the ante day in December, we had at that time point 31 evaluated patients, and they're still looking.

Okay, great. Thank you and then regarding and what keeps them up and we'll stay out for Kona.

And I was wondering whether you could come into when we could.

Expect to complete data set for them for that trial and whether that will be enough you think for accelerated approval and.

And the way I'd say talk.

And as I told at the.

On T day in December we had at that time point, and so what do you want and value with patients and and they'd still looking.

At least as promising as we would like it to Luke and and we have added two more sites MD Anderson and children told Us Angeles and.

Dr. Merlo: At least as promising as we would like it to look. And we have added two more sites, MD Anderson and Children's Hospital Los Angeles. And we are looking, when we have the first 39 patients, we will be looking at whether we should continue with a particular subgroup of the patients with osteosarcoma relapse, i.e., where the majority of them are.

And and we are looking when we have the first 39 patients we will be looking at whether we should continue.

Continue with a particular subgroup of patients with osteosarcoma relapse I E where the majority of them is and that's the long match or whether we should continue with everybody, but that's a little too early to say, where we will end up but hopefully we will have a dataset of the 39 patient and we can presented at SIOP.

Dr. Merlo: And that's the long match of whether we should continue with everybody. But that's a little too early to say where we will end up. But hopefully, we will have a data set of the 39 patients we can present at SIOP in October this year. Alternatively, we will give an update at the R&D day in December.

And in October this year, Alternatively, we will give an update at the R&D day in December.

Dr. Merlo: We may discuss a formalized supplementary BLA for this.

Okay great.

Discuss net.

Sebastiaan van der Schoot: We need to discuss a formalized supplementary BLA for this; we need to see the data first. Thank you. You're welcome, Sebastian.

Formalized a supplementary BLA for <unk> for this we need to see the data first.

Okay and thank you.

Youre welcome and Duston.

Operator: Thank you. We have no further...

Thank you we have no further questions at this time I would now like to turn the floor back over to management for closing comments.

Thomas Gad: Thank you. We have no further questions at this time. I would now like to turn the floor back over to management for closing comments.

Thomas Gad: Well, thank you, everyone, for listening today. And I hope you agree we had a very exciting 2020, and we look forward to 2021. And thank you, Bo, and thank you, Klaus.

Well, thank you everyone for listening today and.

And I Hope you agree we had a very exciting 'twenty and 'twenty and we look forward to 'twenty to 'twenty, one and thank you Bo and thank you Klaus.

Thomas Gad: Have a great weekend, everyone!

That's a great leap and everyone.

Operator: Thank you. Take care, everybody. Bye.

And they have picked for everybody right.

Operator: Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.

Ladies and gentlemen, this does conclude today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.