Q1 2021 Y-mAbs Therapeutics Inc Earnings Call

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Good day and welcome to the White map Therapeutics incorporated first quarter 2021 earnings Conference call. Today's conference is being recorded let me quickly remind you that the following discussion contains certain statements that are considered forward looking statements as defined in the private Securities Litigation Reform Act of 1995 because.

Operator: Welcome to the WiMabs Therapeutics Incorporated first quarter 2021 earnings conference call. This conference is being recorded. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined in the Private Security Licitation Reform Act of 1995. Because forward-looking statements involve risk and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including the fiscal year ended December 31st, 2021 as filed with the SEC on March 1st At this time, I would like to turn the conference over to Thomas Gad, the company's founder, chairman, and president. Please go ahead, sir.

Forward looking statements involve risks and uncertainties. They are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward looking statements due to a variety of factors, including.

The fiscal year ended December 31st 2021 as filed with the SEC on March 1st 'twenty, 'twenty, one and and the company. So quaintly filed SEC reports at this time I would like to turn the conference over to Thomas Gad, The company's founder Chairman and President. Please go ahead Sir.

Thanks, Joe that's on your.

Thomas Gad: Thank you, Tonya. Good morning, everyone, and thank you for joining us today for our first quarter. 21.

Good morning, everyone and thank you for joining us today for our first quarter.

'twenty one.

So during this quarter, we have continued on execution of our strategy on expanded on all three pillars of our business.

Thomas Gad: So doing this quarter, we have continued our execution of our strategy and expanded on all three pillars of our business, which is first our leading monoconal antibodies, Daniela, and Oberthomat. Secondly, our bi-specific compounds developed under the white biclone tech platform. And finally, the Satter technology platform, which we also refer to as liquid radiation.

Which is first of all leading monoclonal antibodies Daniels on on births map secondly, a bi specific compounds developed on the white bikes on tech platform and finally, the Sada technology platform, which we also referred to as liquid radiation.

We've had a strong start to <unk> 2021 and we are thrilled to submit and marketing authorisation application from Burns from up.

Thomas Gad: We've had a strong start to 2021, and we are thrilled to submit a marketing authorization application for Burtemap for the treatment of pediatric patients with CNN, CNS metastases from high-risk nobostoma in Europe. We submitted that last week on April 27. Further, we gave an update on a Burst Map in the U.S. and after our Type B meeting with the FD on March 26. And here we are continuing to work hard towards being able to resubmit the BLA for on BirthMap late in this second quarter or in the third quarter of this year.

Well the treatment on pediatric patients with CNN.

CNS.

Metastases from high risk neuroblastoma, and and Europe.

And we submitted that last week on April 27.

Although we gave an update on and birth from IP and the U S and also a type b meeting with the FDA on March 26, and.

And here, we are continuing to working hard to what's being able to resubmit the BLA from Birch map.

Late in this second quarter on the third quarter of this year.

We believe these are important achievements as on Birdsmouth and potentially address a significant unmet.

Thomas Gad: We believe these are important achievements as a birth map can potentially address significant unmet medical needs and therefore have a substantial impact on the treatment landscape for CNS metastases where there is currently no standard therapy today. As you know, we received U.S. approval for Danielsa in relapsed primary refractory high-risk norbestoma in November last year. We just started delivering Danielsa at the beginning of February and saw demand from hospitals throughout the U.S., so this is very exciting. The first quarter net sales are 5.4 million, which represents less than two months of commercial sales, and we are pleased to report these first revenue numbers.

On met medical need and therefore have a substantial impact on the treatment landscape for CNS metastasis, where there's currently no standard therapy today.

As you know we received U S approval for Danielle, So and relapsed primary refractory high risk neuroblastoma and November last year.

And we just started delivering Danielle signs at beginning of February and so demand from hospitals throughout the U S. So this is very exciting.

The first quarter net sales of $5 4 million.

It represents less than two months of commercial sales and we are pleased to report these first revenue numbers.

Although we have not provided guidance on Danielle so sales.

Thomas Gad: Although we have not provided guidance on Daniela sales, I'm pleased to note that despite COVID-19 forcing us into a partial virtual launch mode, both revenues and reach exceeded our internal expectations for these first few months, and we could not be more pleased with that. Going forward, the data technology continues to look very promising. We recently had positive feedback from the FDA on our pre-I&D package for our DD2 Sata construct and expect to file an IND in the fourth quarter of this year.

I'm pleased to note that despite COVID-19, forcing us into a partial virtual launch mode.

Revenues and reach.

Seeded our internal expectations for these first few months and we could not be more pleased with that.

I'm going on the Sada technology continues to look very promising and we had we recently had.

Positive feedback from the FDA on a pre IDE package.

On our G D two sada construct.

And expect to file and R&D.

And the fourth quarter of this year.

In addition at ACR and April we reported that pre targeted radio immunotherapy against G. P 833 and <unk>.

Thomas Gad: In addition, at ACR in April, we reported that pre-targeted radioimmunotherapy against GPA-33, in a centenograph model of colon cancer, demonstrated a high therapeutic index, a favorable tumor to tissue ratio showing radioactivity uptake of 122 measured 24 hours after injection. GPA 33 is expressed on 95% of all Polorectial cancers, MD for the GPA 33 starter is targeted for next year. So very

Intergraph models colon cancer demonstrated a high therapeutic index.

A favorable too much on tissue ratio.

Showing radioactivity uptake of 122 measured 24 hours after injection.

G P a 33.

It's expressed on 95 per cent of all cooler.

Colorectal cancers and D. I N D flow the G. P. A 33 Sada is targeted for next year, so very exciting.

The bispecific programs on the other way by clone.

Thomas Gad: The BIS-specific programs under the White Biclone platform continue to advance. Our IND for Niva Tritomat was cleared last year, and we are getting ready to dose the first patients in our small cell lung cancer study this quarter. In addition, we are planning for a phase two expansion in neuroblastoma and osteosocoma later this year. Our CD-33 bidsosel for pediatric AML is scheduled to enter into the clinic in late 2021 and will potentially be addressing an important pediatric unmet need as AML remains one of the most challenging chematological malignancies for children.

Platform continue to advance.

Oh and default NEVA truth on that what's clear last year, and we are getting ready to dose the first patients and our small cell lung cancer study this quarter.

In addition, we are planning for a phase two expansion and neuroblastoma and Osteosarcoma later this year.

Our CD 33, five per se because of pediatric AML.

And is scheduled to enter into the clinic and late 2020 one.

And will potentially be addressing an important pediatric unmet medical need S. AML remains one of the most challenging and.

And that's a logical malignancies for children.

I'm pleased to note that cyclone pharmaceuticals on strategic partner for mainland, China, and Hong Kong received a clinical trial waiver.

Thomas Gad: I'm pleased to note that Cyclone Pharmaceuticals, our strategic partner for mainland China and Hong Kong, received a clinical trial waiver for Daniela in May, which should accelerate our time to market, and we continue to view this opportunity as significant for WIMAPs, potentially serving a large unmet medical need in China. We are very pleased with our progress so far in China. I can also note that Takeda filed a BLA-in-March this year from the citamap in Israel.

Danielle so on March which should accelerate our time to market and we continue to view this opportunity is significant for wimax.

Essentially serving a large unmet medical need and China.

We are very pleased with our progress so far on China.

And I can also note that Takeda filed a BLA and March of this year on the seats and Israel.

So all we are very pleased with the continued interest and boats and yachts and a broken up globally.

Thomas Gad: So overall, we are very pleased with the continued interest in both Danielsa and Burtramap globally. We ended the first quarter with approximately 252 million in cash after having closed the sale of our Danielza Priority Review Voucher for 105 million. Under our agreement with MSK, we received 60% or 62 million of the proceeds of that sale. In addition, we completed an oversubscribed secondary offering led by J.B. Morgan, Morgan Stanley, and Bank of America, in which we sold approximately 2.8 million shares of our common stock, including the full exercise of the overall lotment option at $41 a share. We're solving for net proceeds of approximately 107 million.

We ended the first quarter with approximately 252 million and cash after having closed the sale of our Daniels our priority review voucher for $105 million.

Under our agreement with M. S. K, we've received 60% or 62 million of proceeds on that sale.

In addition, we completed an oversubscribed secondary offering led by JP Morgan Morgan Stanley and Bank of America.

And which we sold approximately two 8 million shares of our common stock, including the full exercise from the over allotment option at $41 a share.

We're solving and net proceeds of approximately $107 million.

So we believe we have a strong balance sheet not only to support the casino compensation of Danielle and potential launch of and brought Smith from.

Thomas Gad: So we believe we have a strong balance sheet, not only to support the continued communication of Danielsa and potential launch of on Birdsmap, but also to advance our Lutetium conjugated on Birdsmap D-TPA construct and neither trotum up into late-stage development. At the same time, we continue to advance our two platforms. The Wi-Fi clone platform and the startup platform.

And also to advance our on lutetium conjugated on Birdsmouth D. G. P. A construct.

And neither children them up into late stage development.

At the same time, we continue to advance our true platforms.

And by zone platform on the Sada platform.

We're very pleased with our current financial position and boat.

Thomas Gad: We're very pleased with our current financial position and both. We'll talk more about that later on this call. Taking our achievements into consideration, we believe Weimarimates is very well positioned to expand on our commercial activities while at the same time advancing our clinical pipeline to continue to address unmet medical needs, and we are very excited to continue to do so. And I'm pleased to hand over the call to Dr. Murla, our chief executive officer. Thank you.

Well talk more about that later on this call.

Checking on achievements into consideration, we believe why and I was just very well positioned to expand on our commercial activities. While at the same time advancing our clinical pipeline to continue to address unmet medical needs and we are very excited to continue to do so and I'm pleased to hand over the call to talk to them or low Chief Executive officer. Thank you.

Thank you Thomas and welcome to Wimax up here and ask first quarter, 2020, one earnings call and they're very pleased that you have chosen to join US today. During the first quarter. We have worked hard to ensure that our pipeline advances to watch the market.

Dr. Murla: Thank you, Thomas, and welcome to WiMAP, Sepurik's first quarter 2021 earnings call. We're very pleased that you have chosen to join us today. During the first quarter, we have worked hard to ensure that our pipeline advances towards the market. Our efforts included initiating commercial sales of Daniels in the U.S., as Thomas just alluded to, while at the same time making progress with the resubmission of the U.S.BLA and submitting the European Marketing Authorization application for VIRMAP.

And that's what's included initiating commercial sales outstanding outside the U S. S. Thomas just eluded you while at the same time, making progress with the Resubmission of the on a bunch of them up here late and submitting the European marketing authorization application on.

In addition, we have initiated a phase II study with NEVA touch on about and.

Dr. Murla: In addition, we have initiated a phase two study with nevatrotomab in small cell long cancer under our own I&D and initiated two phase one two studies with Letetium 177 on bertomap DTPA in medullopostoma and in B7-8-8-Bastoma and in B7-83-positive CNS leptominal metastasis tumors in adult patients, and advanced our ongoing Now, let me turn to Naxitamat.

Most of the long pants on all onto all 90 and initiated two phase one two studies with a.

The teach them 177 on boats and my T. J P eight and Metolachlor stoma, and and B seven H Street positive CNS kept him and he called metastasis too much and adult patients.

And at boss and bonds and our ongoing studies and other areas.

We are also continuing to work on new Bispecific construct and I'll start on programs.

Now, let me turn to and like I said I'm at.

And then he also has indicated and combination with GM CSF for the treatment of pediatric patients one year on H older and adult patients with relapsed or refractory high risk neuroblastoma, and the bone of bone marrow, who have demonstrated a partial response minor response or stable disease two prior therapy.

Dr. Murla: Ananiazza is indicated in combination with DMCSF for the treatment of pediatric patients one year of age or older and adult patients with relapse or refractory, high-risk noropostoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved by the FDA under the accelerated approval regulation based on overall response rate and duration of response. We were thrilled to send out the first commercial vials to treatment centers across the country in early February.

And this indication was approved by the FDA on the accelerated approval regulations.

Based on all response rate and duration of response.

We were thrilled to send out the first commercial and miles to treatment centers, including M. S K across the country and early February.

The total net sales of $5 4 million as Thomas just mentioned and.

Dr. Murla: The total net sales of 5.4 million, as Thomas just mentioned, we are very pleased with the launch. As you would expect, MSK is our largest customer to date, but Viles have been shipped to more than 10 other cancer centers across the country now. And our highly targeted commercial and medical affairs organization has done an outstanding job of educating physicians and nurses about Danielsa. Many treatment centers have had their first experience with Danielza, and we believe that treatments have gone generally very well.

We are very pleased with him with the launch.

As you would expect.

M. S. K is our largest customer to date.

But.

<unk> had been shipped to more than 10, although Kansas eight centers across the country no and our highly targeted commercial and medical Affairs organization has done an outstanding job and educating physicians and nurses about Danielle. So many treatment centers have had their first experience with any outside and we believe that treatments have gone.

Generally very well and it is.

And we have had pre BLA meetings in China, and together with sites and we expect to submit the Chinese BLA and third quarter. This year, which hopefully will lead to a 2020 two approval and launch in China.

Dr. Murla: In addition, we have had pre-BLA meetings in China, and together with Sightloan, we expect to submit the Chinese BLA in the third quarter this year, which hopefully will lead to a 2022 approval and launch in China. Our clinical trials ongoing with Anilza in Barcelona, Spain, and at MSK in New York for our first-line neuropostoma maintenance treatment, as well as chemotherapy combination with necetamap for refrac We are working to initiate an international phase two multi-center trial for Daniela, and both frontline and with chemo-combination treatments. And we also have a phase two osteo-sacoma multi-center trial in Goa.

Our clinical trials ongoing with any outside in Barcelona, Spain, and M. S K and New York flow, well first line neuroblastoma and maintenance treatment as well as chemotherapy combination with it and and like I said and map for refractory neuroblastoma patients are also progressing nicely.

And we're working to initiate and international Phase two multi center trials with any other and both frontline and with chemo combination treatments and we also have a phase II osteosarcoma multi center trial on building.

Dr. Murla: Now turning to Amburtomap, on March 26th, we had a tight B meeting with the US FDA to discuss the road towards resubmission of the BLA for Onbernaap for treatment of pediatric patients with CNS leptomynegal metastasis from norbustoma. We are maintaining a very close and open dialogue with the FDA regarding the resubmission and have scheduled a second type B meeting on June 1st, where we hope to reach final agreement with the agency on the remaining details concerning the granularity of the data from our identified historical control groups and how we will work forward with the agency.

Now turning to our bet on that and.

March 26, we had a type b meeting with the U S. F D. A to discuss the road to watch Resubmission of the BLA on bottom up for treatment of pediatric patients with CNS clipped and I think on metastasis from the oldest on that.

We are maintaining a very close and open dialogue with the FDA regarding the Resubmission and have scheduled a second type B meeting.

On June 1st what we hope to reach final agreement with the agency on the remaining details concerning the granularity of the data from our identified historical control groups and how we would work forward with this and all.

What did you agree on the statistical analysis plan. This additional granularity data was submitted to the update in late April.

Dr. Murla: In order to agree on the statistical analysis plan, this additional granularity data was submitted to the FDA in late April. We still aim to resubmit the Umbudsman BLA in the form of an eroding BLA by the end of the second quarter or in the third quarter of 2021. The European marketing application for Mburtomab was prepared in parallel with the U.S. BLA and was submitted to the European Medicines Agency by email last week on April 27th.

And we still aim to resubmit, the a bunch of a BLA and the former from rolling BLA by the end of second quarter and so on quota of 2021.

The European marketing application from budget was prepared and parallel with the U S B and a and was submitted to the European Medicines Agency EMA last week on April 27th and <unk>.

Valuation of all applications and scheduled for 210 days, however, the breath and clock stop whenever we respond to any questions posed by the H D E and the European regulatory authorities and the truck assumes only once we have submitted our responses. So the 210 days without any.

Dr. Murla: The evaluation of our applications is scheduled for 210 days. However, the Brevue clock stops up whenever we respond to any questions posed by the FDA or the European regulatory authorities, and the clock resumes only once we have submitted our responses.

Dr. Murla: So the 210 days are without any responses from our side. In addition, we have begun staffing for our European commercial organization this quarter, and we are excited to prepare for our first European product launch. As previously disclosed, we are also developing... from the bottom up for diffuse intrinsic pontioma, known as DIPG, in a phase one study at MSK, and we are planning to open a multi-center phase two study for DIPG patients later this year.

Responses from all sides.

In addition, we have begun staffing for our European commercial organization and this quarter and we are excited to prepare for our first European product launch.

And as previously disclosed we are also developing on boat on that but diffuse intrinsic pontine glioma known as D. IPG and a phase one study and M. As Kate and we are planning to open and multi center phase two study, but the IPG patients later this year.

But that's my plastics more Rumsfeld, you must know and that's D S and Sochi Chi we have a phase two study ongoing at M. S. K.

Dr. Murla: For desmoplastic small round cell tumors, known as DSSICT, we have a phase two study ongoing at MSK. Then, turning to the lutecium-labeled version of our umbertoa B7H3 antibody. In October 2020, the FDA cleared our I&D for the 177, Lotetotetototomy, PTPA for the treatment of medulibostoma, which is the most common type of primary brain cancer in children. Medulipostoma are invasive, rapid-growing tumors that, unlike most brain tumors, spread through the serposinal fluid and frequently metastasize to different locations along the surface of the brain and the spinal cord.

Len and turning to the lutetium labeled portion I'll follow on thoughts about piece of a nice three antibody in October 2020, the FDA cleared our IND from the 177 and to teach them on boats on the beach P. Eight for the treatment of medulloblastoma.

Which is the most common type of primary brain cancer, and children, medulloblastoma and base and rapidly growing tumors that unlike most brain tumor spread through the surplus spinal fluid and free can frequently metastasize to different locations along the surface of the brain and the spinal cord.

And our international multi center phase one two trial is open for P. J I think patients when they do look at Soma and based on all the clinical experience from treating 27 patients when the dollar per store with our Iot and once or any one on Burma construct we are.

Dr. Murla: Our international multi-center phase one-two trial is open for pediatric patients with medulla postoma, and based on our clinical experience of treating 27 patients with medulla bostoma with our iodine 131 on burtermar construct, we are very enthusiastic about this new trial and to see this construct moving into the clinic and to get started on establishing safety profiles to determine the maximum tolerated doses of the ambutton In this study known as 301, we hope to leverage our prior clinical experience from iodine 131 on Bertima once again giving the infusion through Anamaya, Casetan, and Bresovar.

I'm very enthusiastic about this new trial.

And to see this construct moving into the clinic and to get started on establishing safety profiles will determine the maximum tolerated doses in this mode of using the on button that antibody and this study known as true you wouldn't be hope to leverage our prior clinical experience from the.

And what's really one on both of them at once giving once again, giving the infusion true and in my Castletown reservoir.

In addition, our basket trial and be seven eighth Street positive CNS, let somebody go Kansas and adults known as study trio true, while we hope to leverage our prior experience from treating more than 25 adults with the Io donate a portion of and brought them up is now opened for the first adult patients to be screened and treated with the 177 O teach them on both of them up to H P.

Dr. Murla: In addition, our basket trial in B7H3 positive C&S leptominical cancers in adults, known as 303-2, while we hope to leverage our prior experience treating more than 25 adults with the iodinated version of ambertomap, is now open for the first adult patients to be screened and treated with the 177 lotitium-um-Mbertum of DGBA. And we are thrilled to widen our clinical reach to On our Bispacifics, we are also excited to extend the nevatrozumat clinical reach to include adult cancer patients in our Phase 2 study with subcontaneous administration of the BISPic. We also plan to expand the ongoing Nevatrototrachympath study into separate phase two arms, one in oobostoma and one in osteosocoma. In addition, we are preparing I&D for the next inline bi-specific antibody.

And we are thrilled to buy it and our clinical and reach to include adult indications.

On our bi specifics. We also are excited to widen that need but trust me much clinical.

Reach to include adult cancer patients at all and Phase two studies with subcutaneous administration upset by specific.

We also plan to expand the ongoing.

Neither trust them up and M. SK interest separate phase, two one and neuroblastoma, and one and osteosarcoma and.

In addition, we are preparing and I and thank you for the treat the next in line by specific antibody. The CD 33 by specific generated on our why Python and platform and the idea for pediatric AML is scheduled for second quarter. This year, which is the June quarter.

Dr. Murla: The CD-33 bi-specific was generated on our Y-Byclone platform, and the I&D for pediatric AML is scheduled for the second quarter this year, which is the current quarter. Now, I was turning to our SADA technology. As you know, we are very excited about the prospects for this technology, and we are making good progress on preparing our four to slow SADA targets for clinical development. At the AACR annual meeting in April, we presented our first animal data for DPA-33 SADA. In a xenographed model of colorectal pyotoneal carcinomatosis, DPA-33 SADA showed a favorable tumor to block radioactivity uptake of 122 hours after injection.

Now turning to our Sada technology as you know we are very excited about the prospects for this technology and we are making good progress on preparing all of Fortis low salad sockets for clinical development at the ACR annual meeting in April we presented on our first animal data for the Tpa study trees on it.

And as Gino grasp models of colorectal ph and Youll Carcinomatosis D. P. A retreat Sada showed a favorable true much blot Rachel radioactivity uptake of 122 measured 24 hours after injection D.

D. P. 833 is expressed on 95 per cent of all colorectal, Kansas and we are targeting and I and D for the G. P. A 33 next year.

Dr. Murla: DPA 33 is expressed on 95% of all colorectyl cancers, and we are targeting an I&D for DPA 33 next year. Our other publicly announced targets include DD2 SADA for Potential Using D2 Positive Solid Summers, for which we expect to submit our first IN in the fourth quarter of 2021. We also have a B783 SADA for the intended use in the treatment of prostate cancer, and we have a HER2 SADA for potential use in breast cancer.

Although publicly announced targets include G D true sada for potential use and TD to positive solid tumors for which we expect to submit all first I and D. In the fourth quarter of 2020 one.

We also have a b seven and eight streets out at for the intended use and treatment of prostate cancer, and we have a hertz, who sada for potential use in breast cancer.

I believe the Sada technology can potentially improve these because he got radio labeled therapies and tumors that have not historically demonstrated meaningful responses to radio labeled agents and we are truly excited about our startup technology on liquid radiation technology.

Dr. Murla: We believe the SADA technology can potentially improve the efficacy of radiolabled therapies and tumors that have not historically demonstrated meaningful responses to radiolabled agents, and we are truly excited about our SADA technology or liquid radiation technology.

With the launch of Danielle.

Dr. Murla: With the launch of Daniela already leading to deliveries to multiple treatment centers across the country and internationally, and the planned resubmission of the Ombudsma PLA coming up, we believe that we are well positioned to continue the development of WMAPs as a commercial stage company. Concurrently, we plan to widen and deepen our pipeline by advancing our antibody constructs through the clinic, predominantly the SADA constructs, the BISP specifics, and the next-generation of Burtomar PCPA radio-label antibodies.

Already leading to deliveries to multiple treatment centers across the country and internationally and the planned resubmission. After the on burden of a BLA coming up we believe that we are well positioned to continue the development of Wimax as a commercial stage company.

Currently we plan to widen and deep and mile pipeline by advancing our antibody constructs true the Atlantic predominantly the sada construct the bi specifics and the next generation and on both from a PPA radio labeled antibodies.

In other words, we remain busy.

Dr. Murla: In other words, we remain busy, and we are very excited to move forward and build a business that helps patients and elevates our continued development. Now, let me invite Bo to share his remarks on his financial performance this quarter. Thank you, Klaus.

And we are very excited to move forward on.

A business that helps patients and elevates our continued development and I'll, let me invite Bo to share his remarks on his call.

This quarters financials.

Okay.

We reported net income for the quarter ended March 31st 2021 of $33 4 million corresponding to 80 cents per basic share was <unk> 75, G and so on a fully diluted basis. This compares to a net loss of 26.6.

Bo Kruse: We reported net income for the quarter ended March 31st, 2000, and 21 cents of 33.4 million corresponding to 80 cents per basic share or 75 cents on a fully diluted basis. This compares to a net loss of 26. 0.2 million or 26 cents per share basic and the loser for the quarter ended March 31st, 2020. The main reasons for the net income to go up are revenues and other income. We reported net revenues of $5.4 million for the quarter ended March 31, 2021, representing the sales of then Yelta, and there were no revenues reported in the quarter ended March 31, 2020.

Point 2 million or 26%.

<unk> per share basic and diluted for the quarter ended March 31st 2020.

The main reasons for the net income to go up its revenues and other income we reported net revenues of $5 4 million for the quarter ended March 31st 2021, representing the sales force and yoga and there were no revenues reported in the quarter ended March 31st 2020.

We also recognized $62 million from monetization of the 10 years of P. O V. As other income in the quarter ended March 31st 2021, whereas there was no other income in the quarter ended March 31st 2020.

Bo Kruse: We also recognized 62 million from the monetization of the Danesa PAB as other income in the quarter ended March 31st, 2021, whereas there was no other income in the quarter ended March 31st, 2020. As we take a closer look at the operating expenses for the first quarter of this year, we note that R&D expenses increased by $3 million, from $18.6 million for the quarter ended March 31, 2020, to $21.6 million for the quarter ended March 31, 2021.

And it would take a closer look at the operating expenses for the fourth quarter of this year. We note that on <unk> expenses have increased by $3 million from $18 6 million and for the quarter ended March 31st 2000, and 'twenty to 'twenty, one 6 million and for the quarter ended March 31st 2021.

This increase was primarily attributable to a $2 million increase and outsource manufacturing expenses, two and a half million dollar increase and employee related costs and $8 million increase and the clinical trials and the first quarter. This year.

Bo Kruse: This increase was primarily attributable to a $2 million increase in outsource manufacturing expenses, $2.5 million increase in employee-related costs, and $0.8 million increase in clinical trials in the first quarter of this year. The increases were partially offset by a $3.1 million decrease in outsource research and supply.

Increases.

Partially.

Offset by a $3 $1 million decrease and outsource research and supplies.

Selling general and administrative expenses increased by $3 9 million from $8 1 billion in the quarter ended March 31st 2022 12 million for the quarter ended March 31st 2021.

Bo Kruse: Selling general and administrative expenses increased by $3.9 million from $8.1 million in the quarter ended March 31, 2020, to $12 million for the quarter ended March 31st, 2021. The increase in selling general and administrative expenses primarily reflects a $3.3 million increase in employee-related costs, including salary, benefits, and non-cash, stock-based compensation for present. We ended the first quarter with a cash position of 252.3 million compared with the 2020 year in a cash position of 114.6 million.

The increase and selling general and administrative expenses, primarily reflects a $3 3 million dollar increase and employee related costs, including salary and benefits and noncash stock based compensation for personnel.

We ended the first quarter with a cash position of $252 3 million compared with the 2020 year and cash position of $114 6 million.

Increase was driven partly by the completion of the sale of five or 10 years. The P O V and January.

Bo Kruse: The increase was driven partly by the completion of the sale of our Danese PVE in January, and partly it reflects the 107.7 million net rates in conjunction with our secondary offering in February. Cash used in operating activities shows that the cash burn increased by 10.1 million to 31.9 million for the quarter ended March 31, 2021. The increase was primarily caused by an increase in operating expenses for the period as our work on the Umbudsma BLA resubmission has progressed.

And partly it reflects the $107 seven.

And $1 billion net rates in conjunction with our secondary offering in February.

Cash used in operating activities show that the cash burn increased by $10 1 million interest 31 9 million for the quarter ended March 31, 2021. The increase was primarily caused by the increase in operating expenses for the period and that's all work on it but it might be on a resubmission as true progressed.

We will continue to accelerate the loans activities is often elsa and embed them up it's a true which has also caused our operating cash burn and true increase we expect.

Bo Kruse: We'll continue to accelerate the launch activities of Danielsa and Alberta Map if approved, which has also caused our operating cash burn to increase. We expect the cash burn for operating activities for 2021 to remain roughly in line with the rate of the first quarter of 2021. We continue to believe that WMAS remains in a healthy financial position.

The cash burn from operating activities for 2021 to remain roughly in line with the rate of the first quarter of 2021.

We continue to believe that Wyman should remain in a healthy financial position.

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

Thomas Gad: This concludes the financial update, and I'll now turn the call over to Thomas. Thank you, Bo, and thank you, Klaus. Latonia, I think we can open up the lines for Q&A at this point. Thank you.

Thank you Bo and thank you Claus, let Tony I think we can open up the lines from Q&A at this point. Thank you.

Thank you at this time, we will conduct a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad income.

Operator: Thank you. At this time, we will conduct 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 Q. You may press star 2 if you'd 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. Once again, that's Star 1 at this time. One moment while we pull for our first question. Our first question comes from David Lebescu from Morgan Stanley. Please proceed.

Formation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue for participants using speaker equipment and it may be necessary to pick up your handset before pressing the star keys once again Thats star one at this time, one moment, while we poll for our first question.

Our first question comes from David Lewis from Morgan Stanley. Please proceed.

Well. Thank you very much for taking my question Congrats on the nice launch.

David Matthew Nierengarten: Thank you very much for taking my question. Congratulations on the nice launch. My question is about the launch itself. Are there any specific dynamics regarding the initial uptake, aside, obviously, from Memorial Slovak?

And my question is on the launch itself are there any specific dynamics regarding the initial uptake aside obviously from from Memorial Sloan Kettering Kettering are being the largest customer.

David Matthew Nierengarten: and Kettering being the largest customer.

Is there any.

Stocking that some hospitals might do to prepare and will there be a lumpiness that we might see as the year goes on.

David Matthew Nierengarten: Is there any stocking that some hospitals might do to prepare? Will there be any lumpiness that we might see as the year goes on, just given the nature of the small population? Any insight?

Given the nature of the small population any insight you might provide there would be helpful.

David Matthew Nierengarten: Any insight you might provide would be helpful.

Yeah, absolutely. Thank you, David and and I think of course, there were a number of patients that was converted from special license use on compassionate use <unk>.

Thomas Gad: Yeah, absolutely. Thank you, David. And I think, of course, there were a number of patients that were converted from special license use or compassionate use when the product became commercially available that were converted at MSK. But I don't think you'll see any stalking of this.

When the product became commercially available debt that was converted at and mesquite, but I don't think you'll see any stocking oh. There. So that's just reflecting you can say and maybe a quicker ramp up and then you could have expected, but but I definitely don't.

Thomas Gad: So that's just reflecting, you can say, maybe a quicker ramp up than you could have expected, but I definitely don't can foresee that from the ordering that we have seen that sites are stocking up and are saying that typically the site will be using two vials per infusion per patient and typically doing cycle three infusions Monday, Wednesday, Friday. So if they're planning to treat the patient next week, they would have ordered the product by yesterday this week, six vials for the next week.

Foresee that net debt from then ordering that we have seen that that sites are stocking up anything typically beside we'll be using a two vials per infusion per patient and typically doing flash cycle tree intrusion Monday Wednesday Friday. So so if they are planning to treat the patient next week and they would have on what does the product.

By yesterday this week six miles for the next week and and then.

Thomas Gad: And then so we get, and we get, and we can see that's the pattern we see from both at MSK and also sites outside MSK. They order for the patients that they are planning to treat the following week, and because we can ship basically day-to-day and it's a relatively expensive product, so I don't think there's any stalking issue.

So we get and and we can see that that's the pattern. We see from both at the M. S. K and also sites outside and MS. Kate They order for the patients that they're planning to treat the following week.

And and because we can ship basically on a day to day and it's a relatively expensive products. So so I don't think there's any stocking issue.

And and I think as I said, we are very comfortable with the initial accounts. We are in particular and very pleased to see that and number of sites and so said more than 10 sites outside amoskeag have started using daniels.

Thomas Gad: And I think, as I said, we are very comfortable with the initial loans. We are, in particular, very pleased to see that a number of sites, as I said, more than 10 sites outside MSK, have started using Danielsa. And I think some of them have actually treated quite a few patients now, so they're continuing to put new patients on treatment. So, a very good start for it. I was very happy with the sales teams.

And and I think some of them have treated actually quite a bit of patients now so and continuing to put new patients on treatment. So very good start for us very happy with it.

Air Force.

Okay, that's helpful and as far as the special license use.

Thomas Gad: So that's helped? As far as the special license use being converted, was that mostly done at this point? No, that happened in February. So that's done.

And being converted is that mostly done at this point or should we expect more of those patients to convert AR as the year progresses.

No that that happened and in February.

So that's done so nobody that no more no more patient debt early access and I think the last clinical trials and.

Thomas Gad: So nobody, no more patients had early access. And I think the last clinical trial patients, so there were still a few study patients that needed to go into our clinical trials, but that also happened in the first quarter. So we don't have any additional clinical trial recruitments ongoing in the U.S. for Exitamat, so I think we will have no more early access patients and no more clinical trials. Thank you very much. Thank you very much, Edna.

So and there was still a few Ah Ah study patients that needed to go into to our clinical trials, but that's also happened and in first quarter. So so we don't have any additional clinical trial recruitment is ongoing and the U S. Four and makes it on that.

So I think we all know more early access patients and Nobel and technical trials.

Thank you very much for taking my questions and again congrats on the first quarter. Thank.

And then give them up.

Our next question comes from Alec Stranahan with Bank of America. Please proceed.

Alec Warren Stranahan: Our next question comes from Alex Stranahan with Bank of America. Please proceed.

Hey, guys. Thanks for taking our questions and one off from my congrats on the launch so far as well on two from me.

Alec Warren Stranahan: Hey guys, thanks for taking our questions and want to offer my congratulations on the launch so far as well. Two from me.

So the first United Therapeutics posted better than expected sales for Rituxan and <unk> and they pointed to the fact that kids are starting to come back for treatment on that.

Alec Warren Stranahan: So the first, United Therapeutics posted better than expected sales for unitoxin in one Q, and they pointed to the fact that kids are starting to come back for treatment as the pandemic abates. So I'd be interested to hear whether you're seeing similar market dynamics for Danielza. And then any feedback you're receiving on clinical experience and treatment sites outside of MSK that I may be using Dan Yelka for the first time would be great. Thanks. Thanks, Alec.

The pandemic abates, so I'd be interested to hear whether you're seeing similar market dynamics for Daniels AR and then any feedback.

And you're receiving on clinical experience and treatment sites outside of M. S. K that are maybe using Danielle so for the first time would be great. Thanks.

Thanks, and I like and and.

I think it's it's difficult for us to say anything about where the patients are coming back from COVID-19, I would say the number of patients. We see undecided. We know the best which is of course M. S. K is pretty stable with stable last year and and it doesn't seem to have changed a lot I think what I'm day increased sales number for United Therapeutics.

Thomas Gad: And I think it's difficult for us to say anything about whether patients are coming back from COVID-19. But I would say the number of patients we see on the side we know the best, which is, of course, MSK, is pretty stable. Was stable last year and doesn't seem to have changed a lot. I think the increased sales number for United Ceputics is, to the best of my knowledge, two things. It's a plus 13% price increase by January 1st.

To the best of my knowledge is are two things its and plus 13% price increase by January 1st, which always helps a bit and but it's also the fact that United Therapeutics. As you May also have seen and that report.

Thomas Gad: Which always helps with this, but it's also the fact that United Therapeutics, as you may also have seen in their report, decided to abandon their attempt to get a supplementary BLA for the relapse refractory setting where we have an approval. And I think that made them stop sponsoring clinical trials in the relapse refractory setting. And therefore, those trials are continuing on the COD auspicious, and they probably now have to buy the product. I think it's a combination of those things.

Decided to abandon their attempt to get a supplementary BLA for the relapsed refractory setting where we have and approval.

And and I think that made them stop sponsoring clinical trials and the relapsed refractory setting.

And therefore, those trials are continuing on the C O T auspicious and they probably now have to buy the product. So I think it's a combination of all of those things, but it's great to see that the market has that size because it it's reinforcing nothing and then we have a fantastic opportunity for these patients and the relapsed refractory setting.

Thomas Gad: But it's great to see that the market is that size because it's reinforcing us and that we have a fantastic opportunity for these patients in the relapser factory setting that is offering a treatment that doesn't necessitate hospitalization for eight days in the context of administering this product. And that it's not a 10 to 20-hour infusion, but just the median time to infusion is about 37 minutes for an acetylimate while we're still giving two and a half times as much antibody.

That is offering a treatment that doesn't necessarily necessitate hospitalization for eight days.

And the context of administrative and this product and and and that it's not a 10 to 20 hour and intrusion, but just median time to infusion.

It's about 37 minutes for my next set them up while we are still giving two and a half times as much antibody. So but I think we are very satisfied with the situation but of course also with the fact that our United Therapeutics, Jigsaw gave up and getting the approval for a supplementary BLA and relapsed refractory setting.

Thomas Gad: So I think we are very satisfied with the situation, but also with the fact that United Sapute gave up getting the approval for a supplementary BLA and with actual factors. Did that answer your question? Yeah, the feedback on maybe sites that are using Daniels for the first time, just their clinical, Yeah, I think we have been positively surprised, but I also know that our research nurses and MSLs are doing a great job making sure that the centers are comfortable. I mean, I'm not saying that nobody is seeing any side effects or having any infusion issues. You always have that, in particular with a product like TD2.

And that absolutely with your question on.

Yeah, the feedback on the on maybe sites that are using Daniels, but from the first time just their clinical experience.

Yeah, I think we have been positively surprised when I also know that our research nurses and MSA also doing a great job and making sure that the centers are comfortable I mean, I'm not saying that nobody is seeing any side effects of having any intrusion issues, you always have that and particular with up.

Product like and TD to anybody, but but it's gone very well and as I also mentioned, we have sites that have treated more than full patients already so.

Thomas Gad: But it's gone very well, and as I also mentioned, we have sites that have treated more than four patients already. So that's been very encouraging. So most of the experience has been very positive. Great. Thanks. And congrats again on the progress.

So that's been very and encouraging.

So most of the experience has been very positive.

Okay, great Thanks and.

And on the progress.

Thank you very much on Inc.

Our next question question and come from etc. Route with Guggenheim. Please proceed.

Edsa Derrude: Our next question comes from Edsa Derrude, Guggenheim. Please proceed.

Great. Thanks for taking the questions and offering up on congrats as well on sort of the early launch for Daniels and I guess and first question is is are you seeing enough maybe data week to week to gauge sort of demand and beyond them at scale at this point and I know, it's early and I guess as you.

Edsa Derrude: Great, thanks for taking the questions and offering up a congrats as well on sort of the early launch for Danielle's. I guess the first question is, are you seeing enough data week to week to gauge sort of demand beyond MSK at this point? I know it's early, and I guess, you know, as you think about sort of the second quarter and beyond, and then I have a second question. Well, I mean, I think it's way too early for us to start guiding on anything. We are satisfied with what we saw in the first quarter.

Think about sort of the second quarter and be on and then I have a second question.

Well I mean, I think it's way too early for us to start guiding on on anything we are satisfied with what we saw on the first quarter. If you are broadening it to say would I expect that we would be able to beat for the first quarter sales and the second quarter I, certainly hope, so, but but I think if we are and are at a very early states now.

Thomas Gad: If you were broadening it to say, would I expect that we would be able to beat first quarter sales in the second quarter? I certainly hope so. But I think we are at a very early stage now. But that's also kind of like responding to the issue about the stocking.

But that's also kind of like responding to the issue about the stocking I don't think what we saw with the $5 $4 million net sales and first quarter, what sort of a reflection of somebody stocking the product. So I would definitely expect us to be able to exceed that sales number for the second quarter, but right now to start predicting anything I think it's just too early.

Thomas Gad: I don't think what we saw with $5.4 million in net sales in the first quarter was a reflection of somebody stocking the products. So I would definitely expect us to be able to exceed that sales number for the second quarter. But right now, to start predicting anything, I think, is too early. Great, great.

Yeah.

Great, Great and I've been getting questions around sort of going back to sort of the bystander effect with this antibody drug conjugates and you know we've talked about this earlier on just wondered if you could maybe on sort of compare and contrast, if you will on what sort of the radio nucleotide and and its ability in terms of sort of the buys.

Edsa Derrude: And I've been getting questions around sort of going back to sort of the bystander effect with antibody drug conjugates. And, you know, we talked about this earlier on. Just wondered if you could maybe sort of compare and contrast, if you will, with sort of the radio nucleotide and its ability in terms of the biostender effect, given sort of the interest that we see sort of coming in from investors at this point.

And just given sort of the interest debt that we see sort of comedy and thank.

And from investors to this point.

Yes, I mean, theres no doubt that that the interest in a range of conjugated and.

Edsa Derrude: Yes, I mean, there's no doubt that the interest in radio-conjugated antibody constructs is increasing also from Big Pharma. I think everybody is paying attention to Roche, which recently presented new data with their three-step technology for basically a similar type of technology. The only thing they're to our startup, they're just using full antibodies and a clearing agent, and then instead of using a beta emitter, they're using an alpha-emeter. But with our technology, we can also use the alpha-emeter. I'm a strong believer in the alpha-emeter.

Antibody construct is increasing and also from big pharma I think everybody is paying attention to Roche had recently presented new data with their true step technology from four <unk>.

Basically a similar type of technology, the only thing that true up to our startup there just using food antibodies and and the clearing agent and then instead of using a P. J and made are they using and alpha and beta but with our technology. We can also use outside mirrors and I'm a strong believer and outside mirrors are we just not.

Thomas Gad: We're just not at the point where we have a construct that I'm ready to push formally into preclinical development. But we believe that our proteose technology for using alpha-metters with our Satter-Tec will be ready within the next 12 to 18 months to initiate formalized development. So we do see a lot of interest. We also get a lot of interest from potential pharma partners to work with us on this technology. I think for everybody that looks carefully at Sata-tech, it stands out compared to anything else that's out there in the radioconjugated field, and that's also the feedback that we are starting to get from potential partners. Did that answer the question?

At the point, where we have a construct that I'm from.

Ready to push formally into preclinical development.

But but we do believe that our approach is technology for using alpha and made us with our solid uptake will be ready within the next 12 to 18 months to initiate a formalized development.

So we do see a lot of interest and we also see a lot of interest from from from potential pharma partner tool to work with us on on this technology I think for everybody that looks carefully at the side I'll check it stands out compared to anything else that's out there and and the radio conjugated field and and that's also the feedback that that'd be stopped getting.

From a potential partnering.

Did that answer on the Christian.

Yeah, just maybe more specifics around sort of the bystander effect with with video and yogurt.

Edsa Derrude: Yeah, just maybe more specifics around sort of the bystander effect with radio nucleotides compared to sort of what we see with ADC. Well, I mean, the challenge with radio nucleotides is that if you don't get rid of them, they keep circulating through your bone marrow, and your bone marrow is the most sensitive organ. You can also see something in the liver and the heart and the kidneys, but the bone marrow is typically where people are limited, and of course also the blood. And with the technology we are using.

Nucleotide and compare to sort of what we see with adcs.

Well I mean, the challenge with the radio nucleotide and if you don't get rid of them. They keep circulating true your bone marrow and your bone marrow is the most sensitive work and you can also see something and the LIBOR and the heart and and and the kidneys, but but the bone marrow is typically what people is limited and and of course also the blood and.

And with the technology, we're using.

Because we give the isotope.

Thomas Gad: Because we give the isotope, Cates, in a Dota molecule that is very tiny, it leaks out through the kidneys within hours after the administration. And there's one thing that is the primary, there's actually two things that drive the radiation damage you get from, to other tissues. And that is the duration of the exposure. And then, of course, also the intensity.

Capes and net dota molecule that is very tiny it leaks out to where the kidneys within hours after the administration.

And and there's one thing that is the primary that's actually true thing that drives the radiation damage to gauge from from flow to other tissues.

And that is the duration of the exposure and.

And then of course also the intensity.

But you can with those few hours of the circulation of how is it true you can get to quite extensive amounts of radiation you may remember that new to Sarah and probe for a newer endocrine too much just given us 200 milligram and on.

Thomas Gad: But you can, with those few hours of circulation of our isotope, you can get to quite extensive amounts of radiation. You may remember that Lutocera, for neuroendocrine tumors, is given as 200 milicharis on a peptide that has a relatively short circulation time, but 200 milacaries is a relatively high dose. That's four times as much as we're giving for the on Burtamath. So I think we will see, and I think that's also reflected in the data from TPA 33, that was presented at ACR with 122fold as much radiation to the cancer cells as we got to the blood in those animals.

On a peptide that is having a relatively short circulation time, but 200 milligrams it relative to high dose that's four times as much as we're giving for the on board them up. So I think we will see and I think that's also reflected with the data from the a tpa should treat that was presented at ACR with 122 fold as much radiation to the Kansas.

As we got to the block and in and those animals.

Thomas Gad: I think that is what we can show that nobody else can show. The only other data in this ballpark you can see is coming out from the tree-step procedures where you use a dextron-like molecule to... eliminate all circulating full antibodies, but for a cancer patient to lose all their antibodies is probably not an optimal setting. It works fine in an animal, but I would be cautious about exposing cancer patients to the risk of losing all their circulating antibodies, including potential antitumal antibodies.

And that is what we can show that nobody else can show the only all the data in this ballpark you can see is coming out from the Trinidad procedures, where you use extra and like molecule to and.

Eliminate all circulating full antibodies, but from a cancer patient to lose all your antibodies, there's probably another and optimal setting it works fine and and animal, but I would be cautious on on exposed and cancer patients for the risk of losing all day circulating antibodies, including potential anti tumor antibodies.

Thomas Gad: But that's a completely different discussion. The time will show. Right, great, thank you, and congrats again on the progress.

But that's a completely different discussion.

Time will show.

Right.

Thank you and congrats again on the progress.

Thank you very much.

Our next question comes from Joe Thome with Cowen. Please proceed.

Joe Thome: Our next question comes from Joe Thome with Cowan. Please proceed.

Hi, there good morning, and thank you for taking my questions and just a couple on the launch I think and just walk us through a little bit the process of bringing new centers on board is there a duration that's associated with that and you have to work through any sort of kind of P and T Committee approval and order to get Daniel the on board broadly.

Joe Thome: Hi there, good morning, and thank you for taking my questions. Just a couple of them about the launch. If you can just walk us through a little bit the process of bringing new centers on board. Is there a duration that's associated with that? Do you have to work through any sort of kind of P&T committee approval in order to get Danielle on board broadly? And then second, from a reimbursement perspective, have you seen any pushbacks from any centers outside of MSKCC? and how much time will it take if there is any to stabilize that? Thank you.

And then second from a reimbursement perspective have you seen any pushback from any centers outside of M. S. K C C.

And and how much time will it take if there is any to stabilize that thank you.

Sure. So we have a pretty clear set up for this and and we also have a hot where we can help getting ah patients registered and and help also getting reimbursement in place typically what happens is that first of all I, we haven't and curt's any problems getting a commission.

Thomas Gad: Sure. So we have a pretty clear set up for this, and we also have a hub where we can help get patients registered and help also get reimbursement in place. Typically, what happens is, first of all, we haven't encountered any problems getting permission at sites to actually bring the product into hospitals. So that has been operating pretty smoothly. Almost everybody has been interested in getting practical assistance, in terms of talking to research nurses that know about the practicalities around the administration of the antibody and our MSLs about the potential side effects, etc.

Commission and sides to to actually bring the product into the hospitals. So that has been operating pretty smoothly.

Almost everybody has been interested in getting a practical assistance in terms of talking to research nurses that know about the practicalities around the administration and the antibody and L. A and myself about the the potential side effects et cetera.

And so so that has been quite smoothly.

Thomas Gad: So that has been quite smoothly. Reimbursement, of course, we were very interested and excited about how that would actually go. And I can say until now we have not had a single patient that was refused reimbursement. And most, I would say, more than 90% of the patients get the reimbursement in place within one to two weeks after the doctor suggests that they should have an acinamate. We've only had one patient where it took four weeks, and that was the only time we had that insurance company involved in the process.

Embarrassment of course, we were very.

Interested and excited about and how that would actually go on and I can say until now we have not had a single patient that was refused reimbursement and most I would say eat and more than 90 per cent of the patients get the reimbursement in place within one to two weeks. After the doctor suggest that they should have next to them and we've only had one patient where it took four weeks.

And that was the only time, we've had that insurance company and into the process and and they gave in and and that's accepted reimbursement and that was no issues with that and yet.

Thomas Gad: And they gave in and accepted reimbursement. There were no issues with that in the end. So that has been very nice and very successful. We were pleased with that. There's no doubt in my mind that we are addressing an unmet medical need. And I also have heard about the first cases of patients where the parents have actually pointed through the possibility of Rath and, in this elapsophactory setting, treating their kids with dynotoxymab and chemo asked for next to the map. So I think we are making good progress. That's great.

So that has been very nice and very successful so and so we were pleased with that.

No doubt in my mind that we are addressing an unmet medical need and and they also have heard about the first cases of patients that were the parents have actually pointed toward the possibility of rather and in and there's a relapse refractory setting treating that kids with a guy and I talk to him up and chemo asked for it makes it a map. So I think we are making.

Joe Thome: That's great and very helpful. Thank you very much.

Good progress.

That's great and very helpful. Thank you very much.

Yeah.

Our next question comes from Robert Burns with H C. Wainwright. Please proceed.

Robert John Burns: Our next question comes from Robert Burns with H.C. Wainwright. Please proceed. Hi guys. Thanks

Hi, guys. Thanks for taking my questions and congrats on the launch and as long as the quarter on just one from me if I might so I'm just curious as to how many of the tier one prescribers and to your commercialization team and been able to make contact with to date and does the rate of contact.

Robert John Burns: Hi, guys. Thanks for taking my questions, and congrats on the launch as well as the quarter. Just one for me, if I may.

Robert John Burns: So I'm curious as to how many of the tier one prescribers your commercialization team has been able to make contact with to date? And does the rate of contact track with your own internal expectations, or has the pandemic affected it? Well, I can say that I don't know what the rate is in terms of tier 1 customers that we have actually made contact with, but I would guess that we have made contact with about two-thirds, at least of them. And I can also see that among the sites that we have started shipping product to, there are a couple of really big tier 1 hospitals that have started trying to use Nekxenema. Okay, that's completely fair.

Track with your own internal expectations or has the pandemic affected it.

Well I can say that.

I don't know what the rate and terms of tier one.

Customers that we have actually made contact with but I would guess that'd be a made contact with about two thirds at least of them and I can also see that among the sites that we are I've started shipping product to there's a couple of really big tier one hospitals that have started to.

Trying to use a next set them up.

Okay. That's completely fair one additional follow up on sort of curious as well and it seems you know you've made contact with two thirds of the tier one prescribers are you know what is the average timing between contact and actual ordering of Daniels and has there been any gating factors on the prescriber and outside of the free.

Thomas Gad: One additional follow-up question, I'm sort of curious as well, since you've made contact with two-thirds of the tier one prescribers. What is the average timing between contact and actual ordering of Danielle's medication, and have there been any gating factors on the prescriber end, outside of the frequency that these patients are seen that have limited Danielle's output? Rob, I think it's way too early to start elaborating on that. Of course, we have a lot of statistics on this now, but it's only been two months. And, actually, as we are speaking now, it's for three months.

And see that these patients are seen and.

And let me Daniel on the offering.

Rob I think it's way too early to start up and elaborating on that of course, we have a lot of statistics on this now, but but it's only for two months and as I said, Oh actually as we are speaking now is for three months, but.

Robert John Burns: But I would say I've not heard about any sides, tier one, tier two, tier three, that have said, you know, this is not relevant. I mean, sometimes it's the attitude, especially if they were principal investigators in the Nexima or the ombudomop clinical trial, not on Persma, the unitoxin clinical trials, that they can do everything they need for these patients with unitoxin, I mean, it gives all by itself that if you have a clinical study where only 42% of the patients go into remission, you have 58% of your patients that have an issue.

I would say I've I've not heard about any sides tier one tier two tier three and that has said you know this is not relevant I mean, sometimes this is up the attitude, especially if they were principal investigators on the next set of my Oh.

Both of them up and clinical trial, not on especially on the unit talks and clinical trials that they can do everything they need for these patients with <unk>.

And unit toxin, but in reality it is not the truth I mean.

It gives all by itself that if you have a clinical study with only 42 per cent of the patient come into remission and you'll have 58% if you're a patient that has an issue. So that's up but but you know we are very early into the launch you're very happy with what we have seen and I'm. In particular are very happy that we haven't been able to get actual commercial sales to more than 10 sites out.

Thomas Gad: So there's a, but, you know, we are very early into Lawrence. We're very happy with what we have seen, and I'm in particular very happy that we have been able to get actual commercial sales to more than 10 sites outside MSK so this early on in the launch process. And we keep pushing out there and are seeing, I would say, continued strong interest in the product.

<unk> M S K.

So this early on and the launch process and and we keep pushing out there and are seeing I would say continued strong interest and and the product.

Robert John Burns: No, I completely agree. Thank you for the clarity lesson. Thank you. Have a good thing.

No I completely agree thank you for the clarity Klaus.

Thank you and good day.

Our next question comes from Peter Lawson with Barclays. Please proceed.

Peter Lawson: Our next question comes from Peter Lawson with Barclays. Please proceed. Hey, thanks for taking the question.

Hey, Thanks for taking the question and just just as we sit and think about that is true.

Peter Lawson: question just as we think about the sales over the last quarter or part of the quarter and how they've trended and What does that look like going into April? Well, I think it's very early for us to give any indications. I think I've stretched myself as far as I can when I said I certainly foresee that we would be able to outperform the sales of the first quarter and the second quarter.

Sales at school.

And I have trended and what does that look like going into April.

Yeah.

Well I think it's it's very early for us to give any indications I think I've stretch myself as parts of Canada, and I said I I suddenly foresee that that will be able to outperformed the sales of our first quarter and second quarter. So so so definitely we have no indications that debt, but what we saw in the and.

Thomas Gad: So definitely, we have no indications that what we saw in the first quarter is not reflecting real sales or use as a product. As I said, we can see the sites are actually ordering when they have a patient. They're getting ready to treat the patients the next week. They order before the end of the previous week.

The first quarter is not reflecting our REO sales or use of the product as I said, we can see the sites are actually ordering when they have a patient and they're getting ready to treat the patient and the next week. They order before the end of the previous week.

Thomas Gad: So nobody is stocking up, and I can, you can, you know, if you look at our clinical trial data that has been published, the median, or the average number of doses or cycles, sorry, the average cycle number per patient in this relapsar factor is 5.3 cycles of antibody. And so that takes into consideration that some patients drop off after one cycle, and some patients progress after three or four cycles and, therefore, drop off.

And so nobody is stocking up and and I can you can you know if you look at our clinical trial data that has been published the media and Oh, the average number of doses or cycle, sorry and that.

And every cycle number per patient and and this relapsed refractory. So it was 5.3 cycles with antibody.

And and so that takes into consideration that patients some patients drop off after one cycle and some patients progressed after three or four cycles, and therefore trouble, but you end up with on average because we say we get five cycles. After you come into remission and that typically happens after one two or three cycles and so if youre in Michigan have to treat.

Thomas Gad: But you end up with an average because we say we give you five cycles after you come into remission, and that typically happens after one, two, or three cycles. And so if you are in remission after three cycles, you end up with eight cycles. So the median is expected to be 5.3 based on our clinical trial data.

And so you end up with eight cycles. So the media and is expected to be $5 three based on our clinical trial data and that means that old and new patients. That's the audit and February and in March and in April.

Thomas Gad: And that means that all the new patients that started in February and in March and in April, they will continue for an average of 5.3 cycles, which means the February patient will, on average, finish their treatment in July. And so that means that we have a number of patients that come back, right now, for retreatment every month.

And they will continue for on average of $5 three cycles, which means the February patients.

Well on average and finish that treatment in July.

And so and so that means that debt, we have and number of patients that come back.

And right now for pretreatment.

Every months.

Peter Lawson: Did that answer the question? Yeah, that's really helpful. What percentage of the sites do you think are treating more than one patient or, I guess, discontinuations or you've had decisions from decisions not to use this again, that kind of pros? I don't see, yes, but I don't think that I have had any sites that have said, well, this was such a bad experience that I'm never going to use next to them again. I don't think that has happened yet. It may happen at some point, but, you know, it hasn't happened yet.

Did that answer the question.

Yes, that's really helpful citizenship and do you think that are treating more than one patient.

And I guess discontinuation.

Decisions from physicians to use this again.

Just the kind of.

And I don't I don't yes.

Any sites that have set up but this was such a bad experience and I'm never going to use and exit them up again, I don't think that has happened yet and it.

They have and at some time point, but you know it hasn't happened yet.

But but and and and I think that's definitely a number of sides that have.

Thomas Gad: But, but, and I think there's definitely a number of sites that have, as I said, reported positively back and started treating not only one patient but several patients. But, as I said, we are very early into the launch. We're talking about very preliminary data. I certainly hope when we have the second quarter call that we will be able to give a bit more details. But I think typically you want to have at least three or four quarters before you start feeling more comfortable about treatment and retreatment and how many patients actually completed all the cycles they were intended and to see whether the 5.3 average number of cycles that we saw in the clinical trials is also reflected in what's happening in the clinic. So I think we are very early on, and I hope that gives you some clarification, Peter. Yeah, that's great. Have you had any sites that have converted from United Stroke? They left up to Australia.

As I said reported positively back and and started trading not only one patients but several patients.

But but as I said, we are very early into the launch we're talking very preliminary data I suddenly opened and we.

After the second quarter.

Cold and he will be able to give me a bit more details, but I think typically you want to have at least three or four quarters before you start feeling more comfortable about treatment and re treatment and how many patients actually completed all the cycles. They were intended and to see whether the 5.3 average number of cycles that'd be soy and the.

Clinical trials is also reflected on what's happening and are in the clinic. So so I think we offer free already on and the.

I hope that gives you.

And some clarification Peter [laughter] yeah.

That's great and if you had any sites.

That's it from Detroit and it flips on the studios.

Well, it's two different indications I don't think any of the sites outside M. S. K that are using and to chucks and would stop using you and the tox and because it's approved and in patients that I and complete remission and frontline. So many of them will probably continue with that for a while until the parents and say hey come on and I don't want My Kid and the hospital I want.

Peter Lawson: Well, it's two different indications. I don't think any of the sites outside MSK that are using eunitoxin would stop using it because it's approved for patients that are in complete remission and on frontline. So many of them would probably continue with that for a while until the parents say, hey, come on, I don't want my kid in the hospital. I want my kid to be treated with a new outpatient treatment. But more data need to be reported, and hopefully, we can at some point get a supplementary BLA for the frontline indication.

My Kid.

To be treated with a new outpatient treatment, but more data needs to be reported and hopefully be at some time point and get a supplementary BLA for the frontline indication, but I think we are as I said very early on now and and so so we are approved and an indication where nothing else is approved of our United Therapeutics, just told us that and the quarterly report that day.

Peter Lawson: But I think we are, as I said, very early on now. And so we are approved in an indication where nothing else is approved for. United Therapeutics just told us in their quarterly report that they are not pursuing a supplementary BLA for those patients.

And not pursuing yourself and mature BLA for those patients.

Peter Lawson: Perfect. Thank you so much. Congratulations. Once again, ladies and gentlemen, to ask a question, that's Star 1 on your telephone keypad. Our next question comes from Tessa Romero, J.P. Morgan. Please proceed.

Okay. Thank you so much congrats.

Okay.

Once again, ladies and gentlemen to ask a question Thats Star one on your telephone keypad. Our next question comes from Tessa Romero and J P. Morgan. Please proceed.

Tessa Thomas Romero: Good morning, guys. Thanks for taking our question and congratulations on the initial progress here. Switching gears to a pipeline question from me, a question actually about the upcoming ASCO presentations. I think you will be giving an update on the Phase 1, DIPG study. How should we be thinking about a win scenario for this update? And then can you remind us what the next steps are in the DIPG and DSRC? indications. Thanks so much.

Good morning, guys and thanks.

Thanks for taking our question.

Congrats on the progress here.

And a pipeline question from me a question actually on the upcoming Ash.

And.

I think he will be giving an update on the phase one the I T. G study.

And how should we be thinking about.

Okay, and then can you remind us what are the next steps and the D. I.

T G M D F. R E T indications thanks, so much.

Thomas Gad: Yes, so the DIPD is an update presentation from what was presented two years ago in 2019 by Marks for Dane, so you'll see data from higher dose cohorts, and you'll see data on more patients, and you'll see additional follow-up on survival. As you may recall, the survival in these patients is typically less than 10% after two years, and very, very rarely do you see patients surviving five years. So that's what you could expect.

Yes, and so the diabetes and updated presentation from what what percentage of two years ago and 2019 by marks per day, and so you'll see data from a higher dose cohorts and youll see data on more patients and you'll see additional follow up on on the survival.

As you may recall that the the survival and these patients is typically less than 10 per cent after two years and and very very rarely you see patients surviving five years. So so so that's what you could expect.

And and in terms of continued planning for the D. I P. D. It's our intention to initiate later this year and multi center phase two study that potentially could support a a supplementary BLA for on bottom up Iot.

Thomas Gad: And in terms of continued planning for the DIPD, it's our intention to initiate later this year a MULSI-SEN-A-Fase-2 study that potentially could support a supplementary BLA for Ombudomab iodine in the indication DIPD. So, but first we need to get the approval for on-Beromab in the CNS-Leptaminol-en-en-en-en-en-en-en-en-elel-Bastoma indication, and then with the data from that phase-2 study, hopefully we can get a supplementary BLA, or as a minimum together with the phase one study from MSK, generate enough data to support reimbursement or a compendial listing for on VATEMPT SETs, for on-MAPI IRETI-D setting. On the DSRCT, as you may also recall, that's a very tiny little indication.

And the indication D. I P. T. So so but first we need to get the approval for on bottom up and C. N S Lepton and NGO neuroblastoma indication and then with the data from that Phase II study hopefully we can get a supplementary BLA all as a minimum together with the phase one study from SK generate enough.

And data to support a reimbursement a companion listing for on but I'm at Iot and did the IPD setting.

On the E. S. S. E. T. S. You may also recall that as a very tiny little indication and it's maybe 150 are young adults and teenagers every year and the U S. That's diagnosed with this horrible sarcoma and.

Thomas Gad: It's maybe 150 young adults and teenagers every year in the U.S. that are diagnosed with this horrible sarcoma in Tepyotunile, and there we give ombiotin as an IP administration in 250 ML of saline solution to these patients. And they first started the phase one study where data was presented at CETOS in 2000. We had shown safety and a clear indication of treatment benefit in the phase one study where patients only were given one dose.

Peer two Neely and there we gave the on both of my body and that's an IP administration and 215 and also a sale and solution.

And these patients and the first study the phase one study with data was presented.

And that's C to us and 2000 and then at 19, we had shown on the safety and a clear indication of treatment benefit and in the phase one study where patients are only giving one dose and now we have expanded into a phase II study where patients received two doses again as I said I think the debt regulatory path.

Thomas Gad: And now we have expanded into a phase two study where patients received two doses. Again, as I said, I think the regulatory pathway for these patients is still a little uncertain in the current setting. As I said, it's an indication for ultra-orphine. Would it be sufficient to have data published just to see any uptake in that? We'll have to wait and see until the product comes to the market and more data is generated, and what the FDA's attitude would be to this, but it's definitely based on the data that's been generated.

For these patients is still a little on certain into Q1 setting.

And so it's an ultra orphan indication.

Would it be sufficient to have data published just to see any uptick and that we will have to wait and see until the product comes to the market and and more data is generated and what the F. D. A attitude would be to this but it but it's definitely the data that's being generated and in that setting also.

Tessa Thomas Romero: Okay, great, thanks, Koss. And then one clarifying question, hopefully it's quick. It's just, have you guided to a number of sites for Danielle's up by the end of this year? I'm just wondering if we haven't given any guidance at all. I think what we have said is, I think, Paul, remind me, what the media and analyst expectation for sales is for Danielle this year. What

Okay, great. Thanks, and then.

One clarifying question and hopefully it's quick and just on have you guided to.

And Skype for Danielle.

And on the here and just.

Wondering it.

Yeah.

We haven't given any guidance at all and I think what we have said is that I think Oh reminds me the media and analyst expectation for sales as per Danielle. So this year what is that as debt 20, so cheap.

Thomas Gad: Is that 20, 30,? Sorry, sorry, it's in the mid-20s. That's in the mid-20s.

And the Mitcham.

And that's in the mid Twenty's and the only thing.

Well, it's not just.

Tessa Thomas Romero: That's not, no, I'm not, cloud, not sales, just sites, so sites use yeah, and that's, but that was my point. We haven't said anything about sites. We have said that we are very comfortable with the median sales estimation by the analysts and feel comfortable that we can definitely reach and, most likely also exceed that medium. But we are still very cautious in what we are. We need to learn more about what's happening out there and also to see how well the centers, and as I said, until now, we have been very positively surprised at how well the centers are managing the administration of NekSIDAMAP. So they are definitely doing a good job. but We are early on in this process, but we are very positively surprised.

Site from site.

Yeah, and and that's what but that was my point, we haven't said anything about sites.

We upset that debt and <unk>.

We are very comfortable with the median sales estimation by the analysts and and feel comfortable debt that we can definitely do reach and most likely also exceed that medium.

But we are still very cautious on what we are we need to learn more about what's happening out there and also to see how well they send us and as I said until now we have been very positively.

And surprised at how well listen this is managing the administration of mixing them up so they are definitely doing a good job, but I thought it would be out early on and in this process and but very positively surprised about how things have been going.

Thomas Gad: I hope that was a little helpful. Not too helpful. No, no, that's great. I just wanted to clarify. Yeah.

Okay, I hope that with a little help go not to.

No no that's true.

Yeah.

Operator: At this time, I would like to turn the call back over to management for closing comments.

Thank you and at this time I would like to turn the call back over to management for closing comments.

Thomas Gad: All right, well, thank you, everyone, for joining us today, and we look forward to continuing to work at Lepambs, expanding all the pipelines and

Alright, well, thank you everyone for joining us today and.

We look forward to continue working on apps and.

And expanding our pipeline and launches.

Well, thank you and have a great weekend.

Thomas Gad: Thank you.

Thank you. This does conclude today's teleconference. You may disconnect. Your lines at this time and thank you for your participation and have a great day.

Thank you.