Q2 2021 Y-mAbs Therapeutics Inc Earnings Call

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Operator: Thank you. Thank you. Thank you for me.

Operator: Good day, and welcome to the YMab Therapeutics, Inc. second 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 Securities Litigation Reform Act of 1995. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company's annual report on Form 10K for the fiscal year ended December 31, At this time, I would like to turn the conference over to Thomas Gadd, the company's founder, chairman, and president. Please go ahead, sir.

Thomas Gad: Thank you very much. Good morning, everyone, and thank you for joining us today for our second quarter earnings call.

Good day and welcome to the why Mab Therapeutics, Inc. Second quarter 2021 earnings conference call.

Thomas Gad: During the second quarter of 2021, we continue to make notable progress across all three pillars of our business. First, our leading monocle antibodies, then YELSA and Bertomat. Secondly, our bi-specific compounds developed under the Y-Biclone platform. And finally, the SADA platform, which we also refer to as liquid radiation.

Today's conference is being recorded let.

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.

Thomas Gad: We had a strong start to 2021. We were very thrilled to submit the marketing authorization to EMA for Mbertomat for the treatment of pediatric patients with CNS leptominical metastases from high-risk normal bestoma back in April. Also, after our type B meeting with the FDA in June, we believe we now have a clearer path towards resubmission of the Ombudsma, BLA, in the form of a rolling submission. We intend to initiate this by the end of this year.

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 those risk factors discussed in the company's annual report on form 10-K for the fiscal year ended December 31.

2020 as filed with the SEC on March 1st 2021 and in the company's of subsequently filed SEC reports.

Thomas Gad: As you know, we started delivering Danielsa at the beginning of February, and we are seeing demand from hospitals across the U.S. Second quarter net sales were $9 million, up 67% as compared to first quarter net sales of 5.4 million. During the second quarter, we roughly doubled the number of treatment centers that have gained experience with Danielsa, and we have now delivered it to approximately 20 centers across the nation. Although we have not provided guidance on Daniela sales, I'm pleased to note that both revenues and the number of treatment centers have exceeded our internal expectations for the first two quarters, so we could not be more pleased with that.

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.

Thank you very much good morning, everyone and thank you for joining us today for the second quarter earnings call.

During the second quarter of 2021 and we continue to make notable progress across all 3 pillars of ball of business.

First of all leading monoclonal antibodies and Yeltsin and a bunch of them up.

Secondly, a bispecific compounds developed under the white box on platform and.

And finally, the start up that fall and which also we referred to as liquid radiation.

We had a strong start to 2020.1.

Thomas Gad: I'm also pleased to report the progress we've made so far in China, together with Cyclone Pharmaceuticals, our strategic partner for mainland China, Hong Kong, and Macau. In June, Cyclone Pharmaceuticals Health, a pilot launch presentation of GD2 therapy for Nourbostoma, in the tourism pilot zone in Boa, Hanan, also known as Boa Hope City. Thanks to the drug approval process in Boa Hope City and strong support from the local medical institutions, we believe that Cyclone will soon be able to provide the answer for neurasdoma patients in China.

And we're very thrilled to submit the marketing authorization to EMA for embarrassment for the treatment all pediatric patients with CNS Leptomeningeal metastases from harvest smoke the stoma back in April.

Also off the outside the meeting with the FDA and June we believe and I'll have a clear path towards resubmission of the on Birdsmouth BLA.

And the form of a rolling submission.

We intend to initiate this by the end of this year.

As you know, we started delivering to and Yeltsin at the beginning of February.

And we are seeing demand from hospitals across the U S.

Second quarter net sales were $9 million up 67% as compared to first quarter net sales of 5.4 million.

Thomas Gad: You'll recall that in March, Cyclone received a clinical trial waiver for Danielsa, and in July, the BLA for Daniela for the treatment of patients with relapse and refractory high-res nervousoma was submitted to NMPA in China. We're also very excited to have reached an exclusive distribution agreement with Adium Farmer, also known as Technal Farmer, a company with significant oncology and rare disease businesses and a commercial presence in 18 countries across Latin America. Technopharma will employ sales and marketing expertise to distribute Danielsman on Bertramap if approved in that region. Techno will also submit registration files on our behalf in this territory.

During the second quarter, we have roughly doubled the number of treatment centers that have gained experience with Daniels huh.

And we have now delivered to approximately 20 centers across the nation.

Although we have not provided guidance on and you also the sales.

I'm pleased to note that both revenues and the number of treatment centers have exceeded our internal expectations for the first 2 quarters of we could not be more pleased with that.

I'm also pleased to report the progress we've made so far on China.

Together with the cyclone pharmaceuticals, our strategic partner for mainland, China, Hong Kong and Macau.

And in June and cyclone pharmaceutical health, a pilot launch of presentation of G D to therapy for neuroblastoma.

And the tours and pilot zone, and Boa and on also known as BOE of Hope City.

Thanks to the drug approval process and bow of hope city and strong support of the local medical institutions.

Thomas Gad: Data technology continues to look very promising.

We believe the cyclone will soon be able to provide any other true neuroblastoma patients and China.

Thomas Gad: to look very promising. And Dr. Nykong Chong from Memorial's Lone Kettering Cancer Center recently gave a presentation at Pecks in Boston. To demonstrate how cancer therapeutics often fail in development because of those limiting toxicities or sub-therapeutic doses as a consequence of insufficient therapeutic indexes. Our two-step sata technology uses unique pharmacokinetics to potentially improve the therapeutic index of oncology therapeutics. The BIS-specific programs under the Y-Bi clone platform continue to advance. Our IND for Nevitrota-Mat was cleared last year, and we are getting ready to dose the first patients in our small cell lung cancer study as we speak. I've also planned phase two expansions with a metrotomat in neuropostoma and osteosocoma later this year.

You'll recall that in March and the cyclone received the clinical trial waiver for Danielle zone and in July of the BLA for the and you also for the cheap and of patients with relapsed and refractory high risk neuroblastoma.

Submitted to N M P E and China.

We are also very excited to enter into new and exclusive distribution agreement with ADM pharma also known as techno pharma.

A company with significant oncology and read the cheese businesses and the commercial presence in 18 countries across Latin America.

Checking the pharma will employ the sales and marketing expertise to distribute Danielle side and on boats and that if approved and that region.

Check noble also submitted registration files on our behalf and this territory.

The Sada technology continues to look very promising and Dr. The Nikon Chung from Memorial Sloan Kettering Cancer Center of recently gave a presentation of text and Boston.

Thomas Gad: The IMD for our CD 33 Bicyms.

Thomas Gad: CD-33 bi-specific for pediatric AML has been submitted, and this promising treatment will potentially address a very important pediatric unmet need. SAML remains one of the most challenging hematological malignancies for children today. We ended the second quarter with 233.6 million in casts, so we believe we have a strong balance seat.

So the demonstrate how cancer therapeutics, often fail and development because of dose limiting toxicities.

The sub therapeutic dose and as a consequence of insufficient therapeutic indexes.

Our 2 steps out of technology uses unique pharmacokinetics to potentially improved therapeutic index of oncology therapeutics.

The bispecific programs under the white box on platform.

Thomas Gad: It will support not only the continued commercialization of Danielsa and the potential launch of on birth map but also advance both our Nutisium conjugated and Burtemap DTPA and Nivetruthamap into late-stace development. At the same time, we continue to advance our white bi clone and SADA technology platforms. So we are very pleased with our current financial position, which Boe will elaborate on later in this call.

The new 2 events.

Oh and diesel and the the truth of map was cleared late last year, and we are getting ready to dose the first patients and our small cell lung cancer study as we speak.

Phase 2 expansions, we never chokes on map and neuroblastoma and Osteosarcoma of also planned for later this year.

The I N D fall of CD 33 by specific with pediatric AML has been submitted.

And this promising treatment will potentially address of a very important pediatric unmet needs.

Thomas Gad: Taking our achievement into consideration, we believe Vyrmatch is very well positioned to expand our commercial activities while at the same time advancing our pipeline to continue to address unmet medical needs. And we are very excited to continue to do so. And with that, I'm very pleased to hand over the call to Dr. Klaus Muller, our chief executive officer. Thank you.

S. AML remains 1 of the most challenging hematological malignancies for children today.

We ended the second quarter with $233.6 million of cash. So we believe we have a strong balance sheet and only support the continued commercialization of Danielle zone and the potential launch of on births map.

But also to advance both our lutetium conjugated and burts my of D. G. P E and NEVA truth of map into late stage development.

Klaus Müller: Thank you, Thomas, and welcome to Wymap's Second Quarter, 2021, Earnings Call. We're very pleased that you have chosen to join us today. During the second quarter, we have worked hard to ensure that our pipeline continues to advance to what the market needs. Then he was also approved by the FDA for the treatment of patients with relaxed refractory, high-risk noopostoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

At the same time, we continue to advance our widebody zone and side of technology platforms. So.

And so we're very pleased with our current financial position, which Bo will elaborate on later on this call.

Check out she mentions of consideration we believe biomass is very well positioned to expand our commercial activities. While at the same time of advancing our pipeline to continue to address unmet medical needs and we are very excited to continue to do so and.

And with that and I'm very pleased to hand over the call to Dr. Klaus Miller, Chief Executive Officer. Thank you.

Thank you Thomas and welcome to line, that's that beauty second quarter 2021, the earnings call that the Rfps that you have chosen to join us today during.

Klaus Müller: We were thrilled to ship the first commercial vials to treatment centers across the country during the first quarter, and I'm very pleased with the launch to date. As you would expect, MSK is our largest customer at this stage. But with the continued addition of new sites using Danny Elsie during the second quarter, we expect that in the third quarter, almost 50% of the vials will be sold to other cancer treatment centers across the U.S. Our commercial and medical affairs organization has done an outstanding job educating physicians and nurses about Danielsa, and many treatment centers have now had their first experience with Danielsa. Our understanding is that these treatments have generally gone very well.

During the second quarter, we have worked hard to ensure that our pipeline continues to advance to watch the market.

And then he also for the treatment of patients with relapsed refractory high risk neuroblastoma and the bone of bone marrow will have demonstrated the partial response mine of response or stable disease. The prior therapy was approved by the FDA under accelerated approval pathway.

We were thrilled to ship the first commercial vials to treatments and it's across the country. During the first quarter and I'm very pleased with the launch to date and as you would expect M. S. K is our largest customer at this stage, but with the continued addition of new sites using Danielle said Youre, Inc. Second quarter, we expect that in the third quarter almost 60% of debt.

And those will be sold to other cancer treatment centers across the U S.

Our commercial and medical Affairs organization has done an outstanding job educating physicians and nurses about any Elsa and many treatment centers and I'll have that first experience with any of that our understanding is that these treatments have generally gone very well.

Klaus Müller: In Frontline, updated clinical data for Danielsa and GMCSF for consolidation of high-risk normal stomal patients in complete remission were presented at the American Society of Clinical Oncology, also known as ASCO, annual meeting in June 2021. Patients received five cycles of theniosa and GMCSF in a compassionate use setting for consolidation of high-risk normalostoma in first or subsequent CR. The three-year event-free survival for patients in the first CR was 74% and 19% for second or later CRs.

And frontline updated clinical data for Danielle and Emt exec from the consolidation of high risk neuroblastoma patients and complete remission most of <unk>.

And at the at the American Society of clinical oncology also known as the ESCO annual meeting in June 2021 patient received 5 cycles of Danielle.

And T M CSF and a compassionate use setting for consolidation of high risk neuroblastoma, and first or subsequent to see the true event free survival for patients and first year was 74% and 19% per second of latest E. On the trio of survival for patients and first CR.

Klaus Müller: The three-year overall survival for patients in the first CR was 92% and 66% for second or later CRs. Two-year inventory survival and overall survival were previously presented at our R&D Day in December 2020, and those data points are now poised for the three-year follow-up. I'm very pleased to see how well-bast duration of response and survival rates seem to be holding up. Our ongoing clinical trials for Danielsa in Barcelona, Spain and MSK in New York City for the first-line noroplastoma maintenance treatment, as well as chemo-compination trials for refractory noropostoma patients are all progressing nicely. We are working to initiate international phase two multi-center trials for both frontline and chemocombination treatments, and we also have a phase two osteosacoma trial ongoing. Now, turning to Omburtomart.

And with 92% and 6% to 6% per second of the latest Geos chewy.

Julia event free survival and overall survival of less previously presented at all on D Day in December 2020, and those data points on now poised for the 3 year follow up I'm very pleased to see how well those duration of response and survival rates seem to be holding up.

And the ongoing clinical trials for Danielle and Barcelona, Spain, and M. S K and New York City for the first line neuroblastoma maintenance treatment as well as chemo combination trials for refractory and Augusta on my patients are all progressing nicely. We are working to initiate international phase 2 multi center trials for both frontline and chemo combination treatment.

And we also have a phase II osteosarcoma trial ongoing.

Now turning to on better month on June 1st we had and other type B meeting with the FDA to discuss the route to whats resubmission of the BLA for opt out on that for the treatment of pediatric patients with CNS slips from an income of metastasis from the ultra storm that we are maintaining a very close and open dialogue with the FDA regarding the Resubmission and hoped.

Klaus Müller: On June 1st, we had another type B meeting with the FDA to discuss the route towards resubmission of the BLA for Umbetamad for the treatment of pediatric patients with CNS, lepsum, and ankle metastasis from noblastoma. We are maintaining a very close and open dialogue with the FDA regarding the resubmission and hope to reach a final agreement with the agency for the remaining details shortly. We aim to resubmit the Ombudsma BLA in the form of a rolling BLA by the end of this year.

The reach a final agreement with the agency for the remaining details shortly we aimed to resubmit the BLA.

BLA in the form of a rolling BLA by the end of this year. If approved we strongly believe that a bunch of map of represented very significant advancement in the treatment landscape for CNS metastasis, when no standard therapy exists today.

Klaus Müller: If approved, we strongly believe that Ombetamap will represent a very significant advancement in the treatment landscape for C&S metastasis where no standard therapy exists today. The European marketing application for Umberta Map was prepared in parallel with the USBLA and was submitted to EMA in April of this year. The evaluation of our application is expected to take 210 days plus potential clock stop addition of days.

The European marketing application flow on better map was prepared in parallel with the U S. BLA and was submitted to EMA in April of this year. The evaluation of all application is expected to take 210 days plus potential clock stop addition of days.

Klaus Müller: In addition, interim phase 1 dose escalation data for ombetamap for diffuse intrinsic pontine dialoma, known as DIPD, was presented at ASCO in June and showed the dosing of obertoamab radio labeled with 8 milicarry of iodine 124 appeared to be well-tolerated and proved the distribution volume to potentially cover tumor volumes of up to 20 cubic centimeters. The median overall survival of all 46 patients in the dose escalation study increased by three to four months as compared to the historical control group. This study will continue dose escalation for both infused volume and dose. We are excited to share these results that significantly broaden the potential reach of ambertomab.

In addition, interim phase 1 dose escalation data from third to map for diffuse intrinsic pontine glioma known as the IPD was presented at <unk> in June and showed the dosing of <unk> radio labeled with 8 military of Iot and 124 appear to be well tolerated improved distribution volume to <unk>.

Essentially cover of tumor volumes of up to 20 cubic centimeters. The median overall survival of all 46 patients and the dose escalation study increased by 3 to 4 months as compared to the historical control group.

The study will continued dose escalation for Bose infused volume and dose. We are excited to share. These result that significantly broadened the potential reach of from birth to that the results have also paved the way for our multi center phase 2 study and D. IPG later this year, where we expect to administer up to treat repeated doses from <unk>.

Klaus Müller: The results have also paved the way for our Muti Center Phase 2 study in DIPD later this year, where we expect to administer up to three repeated doses of onberdomab and thereby further improve efficiency. As previously discussed, we are also developing omburtomar, Podestin Small Round Cell Tumers, known as DSSRCT, and we have a phase two study ongoing at MS. The FDA has also cleared our I&D for 177, Lutetium-Omburtimal-P DTPA, for the treatment of medullubostoma, which is the most common type of primary brain cancer in children. Our international multi-center phase 1-2 clinical trial is now open for pediatric patients with medulluburstoma, and the study is based on our clinical experience of treating 27 medulla-plastoma patients with the iodine-131-Omburtum-Map construct.

And thereby for the hopefully improve efficacy.

As previously discussed we are also developing and Burton map of additional plastic small round cell tumors known Sds's Asti cheap and we have of phase 2 study on calling it and Ms. Kay.

Yes.

The yesterday and it's also cleared our IND for 177 to teach them on both of them up the tpa for the treatment of Mcdonald of Stoping, which is the most common type of primary brain cancer and children. Our international multi center phase 1 true clinical trial is now open for pediatric patients with <unk> based on that.

And the study is based on our clinical experience from treating 27 medulloblastoma patients with the iodine 1 sort of do you want on boats and that kind of stops.

Klaus Müller: We are obviously excited to see 177 Lotidium-Mbertum-Map DTPA make its way into the clinic to establish the safety profile and determine the maximum tolerated dose. In this study, known as study 301, we hope to leverage our prior clinical experience with iodine 131 on burtumap, and we will once again be giving the impusion to an amyreous reservoir.

We're obviously excited to see 177 to teach them on both of them up the tpa make its way into the clinic to establish the safety profile and determine the maximum tolerated dose in this study known as study 301, we hope to leverage our prior clinical experience with 18 months of 81 on both of them at and we will once again be giving the infusion true and.

EMEA and rest of us.

Klaus Müller: It is also notable that in June, the Committee for Orphan Medicinal Products, also called Komp, of the European Medicines Agency recommended an orphan drug designation in the EU for 177. Dotisomarbop DGPA for the treatment of medulla mastoma. In addition, our basket trial in B7H3 positive CNS leptamine anglic cancers in adult patients, known as Study 302, where we hope to leverage our prior experience from treating more than 25,000 adults with B7-H3 positive brain metastasis with iodine 131 on Bertomat is now also open for the first adult patients to be screened and treated with 177 Lutetium-Mbertonat DT

It is also notable debt in June the committee for orphan medicinal products also called comp of the European Medicines Agency has recommended and orphan drug designation and the EU from 170, 700 and teach them on both of them up teach P..8 for the treatment of Mcdonnell placed on that and.

In addition, our basket trial and be 7.8 street positive CNS left from an ankle Kansas in adult patients known as study trio true, while we hope to leverage our prior experience from treating more than 25, and also would be 7 H <unk> positive brain metastasis with iodine months or the 1 of them. Both of them that is now also open for first at.

All patients to be screened and treated with 177, the teach them on boats and that <unk> yeah.

Klaus Müller: We are thrilled to widen our clinical reach to include adult patients also now. And then, turning to Y-Bicloin, we have expanded nevatrototomat's clinical reach to include small cell lung cancer patients in our phase two study with subcutaneous administration of the bi-specific antibody. We also plan to expand our ongoing study of nevatrotomab at MSK into two separate phase two studies, one arm in nobostoma and another in osteosocoma.

<unk> and I will turn the call reach to include.

Adult patients also now.

And then turning to the right by column, we have expanded and even trucks of much clinical reach to include small cell lung cancer patients and all of phase II study with subcutaneous administration of us the bi specific antibody. We also plan to expand our ongoing study of need of charter them out at MSA into 2 separate phase 2 studies.

1 of them and know the stoma and in other and Osteosarcoma. In addition, as planned during the second quarter, we submitted and Andy for the next in line by specific antibody and the CDC retreat by specific generated on the lifecycle and platform during the quarter as we had planned we hope to open the study for pediatric AML patients within the <unk>.

Klaus Müller: In addition, as planned during the second quarter, we submitted an IND for the next in-line bispecific antibody, the CD-33 bispecific generated on the Y-Byclone platform during the quarter as we had planned. We hope to open the study for pediatric AML patients within the next six to nine months. Turning to our SADA technology, as you know, we are very excited about the prospect of this technology, and we are making good progress. We are preparing our four disclosed data targets for clinical development.

6 to 9 months.

Turning to our <unk> technology as you know we are very excited about the prospects for this technology and we are making good progress we are preparing all of fortis low sabotage the clinical development the.

Klaus Müller: The first data IND is expected to be against D2. We expect to file this IND in the fourth quarter of this year, and we have recently received what we believe to be positive feedback on our pre-INDI packets from the FDA. In addition, at the American Association for Cancer Research, AACR, conference in April, we reported that pre-targeted radioimmunosherapy against DPA 33 in a xenographed model for colon cancer showed a tumor-to-blood radioactivity uptake of 122 g 24 hours after injection.

The first data and do you expect it to be again.

And.

We expect to file the IND in the fourth quarter of this year and we have recently received what we believe to be positive feedback on our pre IDE package from the FDA. In addition at American Association for cancer Research.

And the conference in April and we reported debt pre tax net radio immunotherapy against the GPA circuitry and of senior crashed model for colon cancer had shown a too much about and Rachel radio activity uptake of 122 measure of 24 hours after injection.

Klaus Müller: DPA 33 is expressed in 95% of all colorectal cancers, and an I&D for DPA 33 Sava is targeted for the end of next year. Our other publicly announced targets include B7H3 SADA intended for the treatment of prostate cancer and H2 SADA for potential use in breast cancer. We believe the SADA technology can potentially improve the efficacy of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radio-label agents, and we are truly excited about this platform.

So the 3 is expressed and 95 per cent of all colorectal cancer.

And and Int for Tpa <unk> Sada is targeted for the index next year.

And our other publically announced targets includes <unk> 7 and 8.3 sort of intended for the treatment of prostate cancer and her 2 sada for potential use of breast cancer.

We believe the Sada technology can potentially improve the efficacy of radio of latency of purity and tumors that have not historically demonstrated meaningful responses to Rachel needs of the agents and we are truly excited about this platform.

Klaus Müller: Looking at some more general aspects, we believe that we are well poised to continue growing WiMAP as a commercial state company, with Danielsa already being shipped to multiple centers across the country, and significant international progress being made under the Danielsa franchise. It's promising, even better than we had hoped for. For Umbertoamap, the past to resubmission of Umbertoamab, the Umbudemab BLA is much clearer after our recent meeting with the FDA, and we now have an understanding of the deliverables that are required by the FDA prior to initiating the resubmission. At the same time, we are widening and deepening our pipeline by advancing our antibody constructs through the clinic, predominantly the SADA constructs, the Bitespics, and the next generation of Burtomab DTPA-Raturitable antibodies.

Looking at some more general aspects, we believe that we are well poised to continue grow why maps at the commercial stage company with any other already being shipped to multiple centers across the country and significant international progress being made on the Daniels of Sunshine.

This promising even better than we had hoped for from both of them up the past 2 resubmission of the PLD.

On both of them at BLA is much clearer after our recent meeting with the FDA and we now have an understanding of the typical set of required by the FDA prior to initiating the resubmission.

At the same time, we of widening and deepening our pipeline by advancing all of antibody construct.

True the clinic predominantly the sada constructs the bi specifics and the next generation on better about the ETP gateway to enable the antibodies and other words, we remain busy and we are very excited to move forward to build of commercial business that helps patients and further leverage of our continued development now let me invite Bo to share his remarks on just caught up on this.

Klaus Müller: In other words, we remain busy, and we are very excited to move forward to build a commercial business that helps patients and further enhances our continued development. Now, let me invite Bo to share his remarks on this quarter's financial results. Thank you, Klaus.

A lot of financials.

Yes.

Thank you Klaus.

Bo Kruse: We reported net revenues of $11 million for the quarter ended June 30th, 2021, representing Daniels sales of 9 million and licensed revenues of 2 million. There were no revenues reported for the quarter ended June 30th, 2020. As we take a closer look at the operating expenses for the second quarter of 2021, we know that research and development expenses decreased by 10.3 million from 30.1 million for the quarter ending June 30th, 2020 to 19.8 million for the quarter ending June 30th, 2021.

We reported net revenues of $11 million per the quarter ended June 30 of 2021, representing the Nielsen sales of $9 million.

And license revenues of 2 million net.

No revenues recorded in the quarter ended June <unk> and 'twenty.

As we take a closer look at the operating expenses for the second quarter 'twenty 'twenty..1 we note that research and development expenses decreased by $10.3 million from $30.1 million for the quarter ended June 30 of 2020 to $19.8 million for the quarter ended June 30 used the 'twenty 'twenty..1 this decrease was primarily attribute.

Bo Kruse: This decrease was primarily attributable to a $13.1 million decrease in milestone payments and licensed acquisition costs provision to the SADA agreements, which were incurred in the ZSASTA license agreements, second quarter of 2020. Selling general and administrative expenses increased by $3.1 million from $10.4 million for the quarter ending June 30th, 2020, to $13.5 million for the quarter ending June 30th, 2021. The increase in selling general and administrative expenses primarily reflects a $3.1 million increase in employee-related costs, including salary, benefits, and non-catch stock-based compensation for personnel related to the loans and commercialization of the NEO.

And sort of $13.1 million decrease and milestone payments and license acquisition cost efficiency of the Sada license agreements, which were incurred and the second quarter of 2020.

Selling general and administrative expenses increased by $3.1 million on.

$10.4 million for the quarter ended June 30 of 2020, $13.5 million per the quarter ended June 30, <unk> 2021 and the increase and selling general and administrative expenses, primarily reflects the 3.1 million total increased employee related costs, including salary benefits and noncash stock based.

And for personnel related to the loans and commercialization of Daniela.

Thomas Gad: We reported a net loss for the quarter ending June 30th, 2021 of 22.9 million, and this corresponds to a 53 cent per share, basic and diluted, compared to a net loss of 40.4 million or $1.1 per share, basic and diluted for the quarter ending June 30th, 2020. We ended the second quarter with a cash position of 233.6 million compared to 114.6 million at year end 2020. The increase reflects the proceeds from the sale of our Daniels of Priority Review Balsha in January, where we needed to take $62 million after sharing 40% of the net proceeds from the sale for our license agreement with MS. Our June 30th, cash balance also reflects the $107.7 million net proceeds raised in our public offering in February 2021, partly offset by the net cash used in operational activities of $50.6 million for the six months into June 30, 2021.

We reported the net loss for the quarter ended June 30, <unk> 2021 'twenty $2.9 million and this corresponds to a 63 Sim.

Basic and diluted compared to a net loss of $40.4 million or 1 on 1 cents per share basic and diluted for the quarter ended June 30 of 'twenty 'twenty.

We ended the second quarter with the cash position of $233.6 million compared to the hungry and $14.6 million at year end 2020 of the increase reflects the proceeds from the sale of all of it and use the priority review voucher and January where we needed 6.2 million ounces of sharing towards the end of net proceeds from the sales per hour.

And typically within the K.

Our June 30, cash balance also with bad debt and grinned and $7.7 million.

The net proceeds raised the big old bringing February of 2021 partially offset by the net cash used in operation of activities of $60.60 and for the 6 months ended June 30 of 'twenty.

'twenty 'twenty 1.

Thomas Gad: We continue to believe why not remain in a very healthy financial position. This concludes the financial update, and I'll turn the call over to Tom. Thank you, Bill. This marks the end of our prepared remarks for today, and I'd like to open up the call for Q&A right now.

We continue to believe why must remain in the very healthy.

<unk>.

This concludes the financial update and I'll and also the call and Elbit systems.

Thank you Paul.

This marks the end of our prepared remarks for today and I'd like to open up the call. The Q&A right now thank you.

Operator: right now. Thank you. Thank you.

Thank you we will now begin the question and answer session.

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

The Julian the question queue. You May Press Star then 1 on your telephone keypad you were here of tone acknowledging your request.

And you were using a speakerphone please pick up your handset before pressing any keys.

To withdraw your question. Please press star and 2 we will pause for a moment of callers join the queue.

The first question comes from Alex <unk>.

And <unk> with Bank of America.

Please go ahead.

Alec Warren Stranahan: Hey guys, thanks for taking our questions. Just a couple on Danielza from us.

Hey, guys. Thanks for taking our questions just a couple of and Danielle the from us.

Alec Warren Stranahan: First, when you look at ways to grow market share in neuroblastoma, I guess at this point, how much is adding new treatment centers versus shifting patients from Danielza that would have otherwise gotten unit toxin, sort of your focus at this point? And how much do you think positive chemo combo data could feed into uptake in the relapse-refractory setting? And then my second question: I believe you mentioned that we could see osteosarcoma data at a conference in the fall. So if you could just help us frame the extent of the data and ballpark on sample size.

The first when you look at ways to grow market share and neuroblastoma I guess at this point, how much is adding new treatment centers versus shifting patients over from Daniela.

That would have otherwise gotten unit toxin and sort of your focus at this point and how much do you think positive chemo combo data could feed into the uptake in the relapsed refractory setting and.

And then my second question I believe you mentioned that we could see osteosarcoma data out of conference and the fall and so if you could just help us frame and the extent of data and ballpark on on sample size and we should expect that and the update that would be great. Thanks.

Alec Warren Stranahan: on sample size. We should expect that in the update. That'd be great. Thanks. Thanks, Alec.

Thanks Alec.

Thomas Gad: Well, I mean, it's too early to say anything about what kind of market share we are digging into, but it's pretty clear to us that, of course, at MSK, they are doing as they've been doing all along while we develop this. They're using it in numerous lines of treatment for an opostoma patient. But I think what we are seeing is that on the new sites that have previously been using dynotoxymab, they are primarily using it for patients where they have tried dynotoxymat, and eventually dynotoxymat in combination with chemotherapy, which is the most common and has not achieved a sufficient response in patients.

I mean, it's too early to say anything about what kind of market share we are digging into but it's pretty clear to us that of course at Emmis cave Theyre doing as they've been doing all along what we develop this day of using it and numerous lines of treatment is not just on the patients, but I think what we are seeing is on on the new sites that debt had previously been using the <unk>.

And Matt they are primarily using it for patients where they have tried Diana talks about the eventually on the touch on that in combination with chemotherapy, which is the most common and and not achieved sufficient response and the patients and then some sides of also started using it and in the primary refractory secondary relapsed patients.

Thomas Gad: And then some sites have also started using it in primary refractory, secondary, and relapse patients. But most of the treatment we are seeing on the sites is kind of like that. That's what also typically happens when you have a new product entering the market. So, there's definitely lots of room for additional growth, and we continue to see very high levels of interest. Also, I can say that our MSLs and our research nurses and our sales teams have had hundreds and hundreds of meetings with and interactions with both physicians and other hospital professionals at sites outside of MSK.

So, but the most of the treatment we are seeing on the sites is kind of like that's what's also typically happens.

And when you have of new product entering the market. So so that's definitely lots of space of additional growth and and we continue to see.

Very high levels of interest and also I can say that our MSL set and our research nurses and.

And our sales teams have had hundreds and hundreds of meetings with any traction with those.

Physicians and and.

And on the hospital professionals at the sites outside of the Miss Queso. So we continue to see is a strong interest and understanding how to use any outside at the sites.

Thomas Gad: So we continue to see a strong interest in understanding how to use Danielsa at the sites. Your last question about the eventual presentation of Osteucommodator. I think it's most likely that you will be seeing the data presented at our R&D day in December. But I think it's too early yet because the study is still missing one patient for recruitment, and then we can do the analysis afterwards. I think was that the answer to your question?

Your last question about the.

The eventual presentation of osteosarcoma data.

I think it's most likely that you will be seeing the data presented at all on the day in December.

But I think it's too early yet because of the study is still missing 1 patients for recruitment and and then we can.

Do the analysis afterwards.

I think once that the answer to your questions.

Alec Warren Stranahan: Yeah, yeah, that's perfect. And if I could just lob another one in. Sure. Could you maybe talk about your, on Burnt Map, your go-to-market strategy in the EU, assuming approval comes, I guess, later this year or early next? Yeah.

Yeah, Yeah, that's perfect and if I could just law of another 1 and share could you maybe talk talk about your from Bert map your go to market strategy.

And the EU, assuming approval comes and I guess later this year or early next.

Yes, it's more likely and we.

Thomas Gad: Yeah, it's more likely since we submitted it in April 210 days. I know that it is, with normal easy calculation, seven months.

We submitted on April of 210 days I know that it is when the normal easy.

Easy calculation of 7 months that would take us to in November but then you have this clock stop situations. So so most likely <unk>.

Thomas Gad: That would take us to November, but you have this clock stop situation. So most likely, EMA will come back to us in September with a bunch of questions after their qualified review of the file. And then we will probably spend somewhere between 30 and 90 days, depending on how detailed the questions they have, putting together the responses, and then the clock stops while we're putting this together. Then the clock starts again when we have submitted our responses.

And we'll come back to us and in September with a bunch of questions. After they are qualified review of the of the file and then we will be probably spending somewhere between 30 and 90 days, depending on how detailed questions. They have and putting together the responses and then the clock stops while we are putting together. This and then the clock starts again when we have submitted.

The responses than if they have additional questions to the responses then the clock stops again, so so although it is called the 210 day revenue period. It means that that's in the ideal situation without any clock stops, but having said that I think it's highly likely that we would be on the market and.

Thomas Gad: Then if they have additional questions about the responses, then the clock stops again. So although it's called the 210-day review period, it means that that's in an ideal situation without any clock stopping. But having said that, I think it's highly likely that we would be on the market in the second quarter next year, pending approval. And we are already in the process of building up a year. European organization that can handle the sales and distribution of Bertimab in Europe.

Second quarter next year pending approval and and we are already now and the process of building up a European organization that can handle the sales and distribution.

And both of them up and Europe.

Alec Warren Stranahan: Was that answering you a question? That's perfect. Thank you.

Is that answering your question.

That's perfect. Thank you.

Thank you and have a nice day.

David Matthew Nierengarten: The next question comes from David Lubowitz of Morgan Stanley.

The next question comes from David Lebowitz with Morgan Stanley.

David Matthew Nierengarten: Thank you very much for taking my question.

Please go ahead.

Thank you very much for taking my question.

David Matthew Nierengarten: First, on Daniel's on the corner, you seem to say that next quarter, MFK would be about 50% of sales. I'm just curious as to, Is that kind of the runway we should expect from MSK going forward as a contributor? It seems that there has to be an upper limit from one hospital.

First on <unk>.

Danielle is on the corner.

And to say the next quarter and thanks, Kay would be about 50% of sales.

And I'm just curious as to.

Is that kind of the run rate, we should expect from that of SK going forward as the.

It kind of contributor it seems that there has to be an upper limit from 1.

Thomas Gad: sales. My first question. Yeah, no, absolutely not.

The hospital as far as how much you can contribute to sales.

The first question.

Thomas Gad: I understand the question. I mean, I don't think MSK is going to be much bigger than we are now. I think the growth is outside MSK, and where we are also continuing to add new centers, basically every month, new centers are joining and working with us. And we can see several of the sites that started using ambertomab, us not on Naxetamat, but then you also early on, have treated more than one patient. I think the highest number is up to six patients outside MSK. So definitely, growth will come from outside MSK. Excellent

Yeah, no absolutely I understand the question I mean.

I don't think MSCI is going to be much bigger than we are now.

You can see the gross this from outside of from S. K.

You're also continuing to add new centers basically every month's NUCYNTA joining.

Working with and we can see several of the size of that started using a bunch of map us net on bearish on the next set them up and then yes. The early on.

And that have treated more than 1 patient I think the highest numbers up to 6 patients outside of them as queso so definitely.

The gross will come from outside and Ms. Kay.

Excellent.

David Matthew Nierengarten: And with respect to the Umberdumab submission, given that the FDA has already reviewed substantial parts of the submission before, what do you anticipate the review process would be like this time? Would they ultimately need the full..., six months, review period, or could it be more abbreviated given that they've probably seen a lot of the data in the past? I tend to agree with you that it will be abbreviated, but I think it's highly likely they will not give us the traditional eight months fast track review due date, but most likely they will be able to approve it before the end of that eight months period.

And with respect of the Alberta, Matt information given that the FDA has already reviewed.

And the substantial parts of the submission.

4.

What do you anticipate the review process would be like this time would they ultimately need the full.

6 months.

You period.

Or would it be more abbreviated given that they probably seen a lot of the data on the past.

I tend to agree with you that most likely it will be abbreviated but I think it's highly likely a day.

It's unlikely they will not give us the traditional 8 months.

<unk> strike of revenue.

The <unk> date.

And most likely they will be able to approve before the end of that the 8 months period, but let's see how it goes with and when we when we get it submitted to be definitely hope and expect to be on the market next year with on both of them up and the U S. Also.

David Matthew Nierengarten: But let's see how it goes when we get it submitted, but we definitely hope and expect to be on the market next year with Lombuton in the U.S. also. Thank you. Thank you for taking my questions.

Thank you. Thank you for taking my questions.

Thank you David.

Robert John Burns: The next question comes from Robert Burns with H.C. Wainwright. Please go ahead. Hey guys.

The next question comes from Robert Burns with H C Wainwright.

Robert John Burns: Hey guys, thanks for taking my questions and congrats on all the progress. Just two from me, if I may. First, you stated in your prepared remarks that Danielza has been shipped to roughly 20 centers as of today. I'm just curious, as we think about the rest of this year, what are you thinking about from an internal metrics sort of benchmark? Where do you think you'll be able to get to by year-end with regard to the number of centers actually prescribing Danielza?

Please go ahead.

Guys. Thanks for taking my questions and congrats on all of the progress just 2 from me from me if I may.

So you can stay there and in your prepared remarks that Daniels is the chip to roughly 20 centers as of as of today I'm. Just curious as we think about the rest of this year. What are you thinking about from an internal metric sort of benchmark, where do you think you'll be able to get to by by year and with regard to the number of centers actively prescribing.

Robert John Burns: And then my second question, so I know that there's going to be a subsequent type B meeting with the FDA this quarter. I was just curious whether there are any other points of alignment that you're seeking with the FDA for, you know, to move forward with that rolling submission. And if so, what are those points that you're still seeking alignment on?

And then my second question, so I know that there's going to be a subsequent and type b meeting with the FDA. This quarter I was just curious whether there are any other points of alignment that youre seeking with the FDA or to move forward with that rolling submission and if so what are those points that you still are.

And seeking alignment on.

Okay.

Thomas Gad: Well, to finish off the last one first, I think we have everything aligned. The FDFs ask us to prepare some analysis, and then we'll be discussing those data points and how we are doing them, and the update is the fiscal analysis plan, and I think we should then be ready to resubmit. So then, but then they would ask us to have a formal pre-BLA meeting and take it. And most likely, it can even be a written response to that.

Just to finish off the first of all on the last 1 first I think we have everything aligned the FDA has asked us to prepare.

On some analysis and.

And then we'll be discussing those data points and the and how we are doing them and the the update of statistical analysis plan and I think we should then be ready to resubmit.

So and.

And then but debt, but didn't they would ask us to have a formal pre BLA meeting.

And Tim and ticketed and most likely it can even be a written response to that so I think yeah.

Thomas Gad: So I think we are not expecting any additional alignment except for making sure that we have understood precisely what the FTA asked us, and they want to make sure that we understand that. So, but I think we are pretty much on track with that. In terms of additional sites, I mean, I think it's, as I previously said, there are about 160 sites in the US that, on a more regular basis, or on a rare occasion, treat patients with an oplostoma.

And we're not expecting any additional alignment and except for making sure that.

We have understood precisely what the FDA asked us and they want to make sure that we understood that so and I think we are.

Pretty much on track with that and.

In terms of additional sites.

I think it's it's as I've previously said Theres about 160 sites and the U S debt on more regular basis, all on the real patient treats patients with neuroblastoma.

Thomas Gad: And I think if we can penetrate into a quarter of these sites, especially if we can penetrate into some of the more important ones, the bigger sites in the first year, I think we have done a pretty nice job. And I think you, hopefully, will see a bit more acceleration than that.

And I think if we can penetrate into the.

The quarter.

And especially if we can penetrate into some of the and more important ones at the biggest sites and the <unk>.

First yes, I think we have done a pretty nice job.

Thank you hopefully can see EBIT more acceleration of debt, but but until now I would have to say that I'm very pleased to see that would be administered to get almost 20 sites.

Thomas Gad: But until now, I would have to say that I'm very pleased to see that we have managed to get almost 20 sites, in addition to MSK, to start using the product. I think it's been a very positive uptake. You know, in the beginning, there were some concerns that many doctors would say we have what we need with dynotoxymar, but that's definitely an attitude that is changing in many places. And also, it seems that the sites are better than we had been concerned about them. They have been concerned about themselves to actually use Thaniyelza, but it is not as complicated as somebody might have tried to convince them it was to use than Yelza.

In addition to that MS. Kate you start using the product I think it's been kind of very positive.

Uptake and.

And you know and the.

And the beginning there were some concern that debt.

And many doctors per se, we have what we need with the.

And it took some of that.

But that's definitely an attitude the this changing many places and on.

Also that net.

And that it seems that the sites.

Better than we had been.

Concerned about them and they have been concerned about themselves to actually used any of that to just not as complicated that somebody might have tried to convince them. It was to us.

Thomas Gad: So I think it would be very positive about the continued development. Awesome. Thanks for the

Danielle zone.

And we are very positive about the continued development.

Robert John Burns: Awesome. Thanks for the clarification, Clouds. Congratulations.

Awesome, Thanks for the clarity of clouds and congrats again.

Thanks, a lot.

Joseph Tom: The next question comes from Joseph Tom with Cohen and Company. Please go ahead.

The next question comes from Joseph Thome, with Cowen and company.

Please go ahead of and good morning and.

Joseph Tom: Good morning, and thank you for taking my questions. Maybe just the first one on the Emburtonabre submission. Are you able to?

Good morning, and thank you for taking my question.

The first 1 on on the and broken out of Resubmission.

Joseph Tom: Are you able to provide just maybe a little bit more context around kind of the additional detailed data the agency requested sort of after the last meeting ahead of the next type B? And then I know the rolling VLA submission is targeted beginning at the end of this year. Are there additional modules then that would need to be submitted next year to sort of complete the submission? And then I have a follow-up question on technology.

To provide just maybe a little bit more context around kind of what the additional detailed data.

On the agency of requested sort of after the last meeting ahead of the next day E and then and of the Rolling BLA submission is targeted to begin at the end of this year.

Are there additional modules and that they need to be submitted next year to sort of complete the submission and.

And then I have a follow up on on Danielle So well.

Thomas Gad: Well, I think it's too early now to say when we will be able to finalize the clinical study report based on the statistical analysis plan that we hopefully will get a green light from the FDA on at this upcoming meeting. But having said that, it was pretty clear that the FDA wanted to make sure that the analysis, where we compare the data from study 1030303-03-133 with the data from the historical control groups, that those two patient cohorts were made comparable.

Well I think it's too early now to say when we will be able to finalize the clinical study report based on the statistical analysis plan that we hopefully get a green light from the FDA on.

And at this upcoming meeting.

But but.

But having said that and it was pretty clear that the FDA and wanted to make sure that the.

On the analysis.

And we compare the data from study 133, <unk> with the data from the historical control groups.

Debt that does too.

Patient cohorts were made comparable.

Thomas Gad: And we're using what's called a synthetic control arm after having discussed this forward and backward with the FDA. So we are putting that together, and that data set, and we have agreed with the FDA about also how to generate the synthetic control arm based on the available historical patient data. So that's what has been going on, and we're building that data database. Actually, we have done it, and the whole data set will be submitted, and the results to the FDA very shortly.

And we're using what's called a synthetic control arm after having discussed this forward and backwards with the FDA.

So we are putting that together and that data set we have agreed with the FDA about also how to.

Generate the synthetic control arm based on the available historical patient data.

So it's that's what's has been going on and we are building debt beta of database of all actually we have done it and to.

And the whole data set will be submitted to and and the results from the FDA.

And very shortly.

Thomas Gad: So I think that's as far as we can get it now. When it comes to when we will be having everything ready for completing the rolling resubmission, I think we'll take that when we have the pre-BLA agreement in place with the FDA. Perfect. And then just in terms of Daniels and news centers, do you get a little more information on kind of how these news sites roll on? Do they take sort of an initial pilot dose and then and then?

<unk>.

That's as far as we can get and now when it comes to when we will be having everything ready for completing the rolling Resubmission I think we will take that 1 we have had the pre BLA agreement in place with the FDA.

Okay, perfect and then.

Just in terms of of Daniel's and New center and he's got a little more information around kind of how these new sites roll on to do they take sort of and initial pilot dose and then and then choose to expand it more broadly to sort of their individual center or is it sort of ordering patterns based on kind of the individual patient.

Joseph Tom: broadly to sort of their individual centers, or is it sort of ordering patterns based on, you know, kind of the individual patients? Yeah, but you can see this happening.

Thomas Gad: Yeah, what you can see what's happening, and that's happening for all sides, is that typically, if they have a patient and they screen the patient, find out they want to put the patients on Danny Elsa, then the treatment would be Monday, Wednesday, and Friday for the first treatment cycle. So they would order the drug for those three treatments. And then, if the patient does well, and they want to continue, then four weeks after the first cycle, they start the second one.

And what's happening and that's happening for all sites is that they typically if they have a patient and the screen the patients find out they wanted to put the patients on daniels than the treatment with the Monday Wednesday, and Friday for the first treatment cycle and so they would order drug for those 3 treatments.

And then if the patient does well and they want to continue then 4 weeks. After the first cycle then they start the second once and they will order. The so they have product for the next 1 nobody audis 4.5 cycles and then leave.

Thomas Gad: They will order it then so they have the product for the next one. Nobody orders for five cycles and then leaves it, and we can see that also, so that's why I mean we receive orders almost on a weekly basis from MSK, and we receive orders from most of the other sites that are treating more patients also on a weekly or biweekly basis. So, I think that's how all sides would do because it's such an expensive therapy, so if you buy six miles and all 30 vials and you only Yep, that makes a lot of sense. Great Thank you very much.

The EBIT and <unk>.

And we can see that also so that's why I mean, we receive on us almost on a week the basis from from the MSA and we receive orders from most of the other sites out of treating more patients also on a weekly or biweekly basis. So so so I.

I think thats, how all sides of a do it because it sits and expensive therapy. So if you buy 6 vials and.

I'm, sorry of the vials and the only end up spending 6 of them and you pay $20000 per vial and then you have the pretty expensive and inventory.

Okay that makes a lot of things great. Thank you very much.

Thanks.

The next question comes from Sarah <unk> with Guggenheim Securities. Please go ahead.

Etzer Darout: The next question comes from Etzer-Diru of Guggenheim Securities. Please go ahead.

Etzer Darout: Thanks for taking a question. Just one question for me on Danielza. So recalls sort of conversations around, you know, increasing engagement with the FDA on the frontline setting, you know.

Great. Thanks for taking the question just 1 question from me on the needs of the recalls of the conversations around.

And increasing engagement with the FDA on the front line setting.

Etzer Darout: Post-launch and with a couple of quarters under your belt, I just wondered if you initiated those conversations.

And at post launch and.

On a couple of quarters under your belt, just wondered if you initiated those conversations.

Etzer Darout: If you initiated those conversations, or if not when you plan to start to have dialogue on sort of a buy-in, if you will, into sort of the plans for a frontline setting for Friada. Yeah, thank you.

Or if not when do you plan to start to.

Logan and sort of a buy and if you will and to sort of the plans for front line setting.

<unk> corporate debt.

And.

Thomas Gad: I think I've been saying before that we expect to do that in the beginning of next year. We are waiting for MSK to close in the first quarter of this year, their frontline study, and then we need some follow-up on the last patients in that frontline study with next setting them up. So when we have those data towards the end of this year, together with the data set with three years of follow-up from Dr. Morr's study, I think we have sufficient material to approach the FDA early next year and have a discussion.

I think I've been saying before that we expect to do that and the beginning of next year. We are waiting for the MSA closed in the first quarter. This year. The frontline study and and then we need some follow up on the last patients and that frontline study with mix of them up so when we have those data towards the end of this year and together with the data.

And with 3 years follow up from Dr. Maura study I.

I think we have sufficient material to approach the FDA.

The early next year and and have a discussion on what additional data.

Thomas Gad: and what additional data could eventually be necessary if we wanted a supplementary VLA approved. So we are continuing to collect the data from the MSK study, and then, together with the data from Dr. Moore's study, I think we have a nice data set to discuss with the agency. Got it. Thank you. Congratulations on the progress.

And should it be necessary, if we wanted the supplementary BLA approval.

So and so we're continuing to collect the data from the M. S case study and then together with the data from Dr. Maura study I think we have and nice dataset to discuss with the agency.

Got it. Thank you congrats on the progress.

David Matthew Nierengarten: The next question comes from David Nearingarten with Wedbush Securities. Please go out.

Thanks.

The next question comes from David Nearing Garden with Wedbush Securities.

Please go ahead.

David Matthew Nierengarten: Thanks for taking my questions. I had a couple. First, on Danielza.

Thanks for taking my questions I had a couple of first on Daniels.

David Matthew Nierengarten: I mean, part of the appeal, or, you know, we've talked in the past about part of the appeal being maybe less of a requirement to refer a patient to a larger center for treatment or things like that. So is that part of this kind of the right word, you know, diffusion into, you know, are they diffusion into smaller centers, diffusion into, you know, use in centers that would otherwise be referring to MSK?

And.

And as part of the appeal.

We've talked in the past about part of the appeal being <unk>.

Maybe a less.

A less of a requirement to refer patients to a larger center for treatment of things like that so is that part of the kind of the.

And the right word the diffusion and 2 are they did the fusion and the smaller centers diffusion and to.

And you use and.

Centers that would otherwise be referring to M. S K and I'm, just kind of curious of part of the.

David Matthew Nierengarten: I'm just kind of curious if part of the selling point here is that, and, you know, it's part of the strength and the prescriptions. And then on Letitium, on the DTPA, on Alberta Mab, I think you commented that you expected the first patient in Q3 this quarter. You know, BID was submitted a few months ago, well, late last year, part of that gap getting sites signed up or, you know, kind of, or trying to find qualified patients. I'm just curious why it's taken a little bit of time there. And, you know, if we could only expect...

Selling point here is that and that's.

Part of the strength and the prescriptions and then on the <unk>.

And you see him on the on the D Tpa and the burden Mab.

Thank you commented that the you expect the first patient and then in Q3 of this quarter.

Yes.

The idea of submitted a few months and well.

Late last year.

Part of that GAAP getting them.

Signed up or the kind of or trying to find qualified patients I'm just curious why and.

And why it's taken a little bit of time, there and.

And if we could expect.

Thomas Gad: you know, for enrollment trends going forward. Sure.

And for enrollment trends going forward. Thanks.

Sure I mean.

Thomas Gad: I mean, um, I think for Daniela, what we are seeing is that definitely sites that might not have treated patients in the past but just referred them to them can now, because it is an easier to handle product, treat patients with Daniela. But I also think that's actually driving some of the bigger sites that could have been showing more resistance to what's moving from what they have been heavily involved in developing themselves, dynotoxymab, to move to what's being open to. actually treat them with any other. Some parents then simply will say that then we go to another side, and actually we'll be using teniosis.

I think for the Daniels.

But we are seeing is that definitely sites that might not have treated patients and the past, but just before it can now because it is at and easier to handle product.

Treat patients with Daniels.

But I also think that's actually driving some of the peak of sites that could have been showing more resistance to what's moving from what they had been heavily involved in developing the myself Dino talk some of that to move to what's being open to actually treat with any other because some parents and simply stayed it and then we go to another site.

And actually we'll be using any of them, but we want to have all the treat the treatment. That's on outpatient treatment. Once you have the new antibody approved by the FDA.

Thomas Gad: We want to have the treatment as an outpatient treatment. We want the new antibody approved by the FDA, so I think that's helping to open up. But again, as I said, it's very limited knowledge we have until now, and we are still learning every day, but very positive about what we have been seeing until now.

That's helping to open up but again thats debt, it's very limited knowledge, we have on until now and we are still learning every day, but but.

And the very positive.

What we have been seeing until now.

Thomas Gad: Also, that some of the bigger COG sites have started using necetamab. In terms of starting to recruit patients with ombotamap, DGP, Lutetia, 177, It has taken a while to get through all the approval processes in the institutions, but both studies are open for recruitment, and I know they are actually screening patients, and I know that they are planning to start treating the first patients also now. So it did take some time.

Also that some of the bigger <unk> sites have stopped using the next set them up.

And in terms of the the.

The starting of recruitment of patients on both of them up <unk> to teach and 177.

It has taken a while to get through all of their approval processes.

And the institutions.

But but.

Both studies of open for recruitment and I know the actually be actually screening patients and I know that they are planning to start trading and the first patient is also now so so it did take some time once it caused by I mean, everybody's flame and COVID-19 per everything so I'm happy to do that to you also on but I think it's.

Thomas Gad: Was it caused by, I mean, everybody is blaming COVID-19 for everything, so I'm happy to do that here also, but I think there are things that had been a little bit delayed in those settings, but it's a complicated treatment.

The other thing.

And a little bit delayed.

And in those settings, but but it's a complicated treatment and hum.

David Matthew Nierengarten: And with the Omair catheters and the radiolabine, with the latium, you have the radio, pharmacy security group involved in addition to the IFD at the hospital. So there's a long process of activities going on. So typically, from when you get an I&D approved today, it is a minimum of six months before you see the first patient entering a study, simply because most institutions do not want to sign a contract. They may tell you that they want to work with you and do this, but until the I&D is approved and the protocol is cap and stone, they're not signing the contract with you. So, and then it's... then you need to go to the IEP also, so things take a long time. I hope that explained what I said.

The catheter and and the regulator and the lutetium you have the radio.

The pharmacy Security group involved in addition to the <unk> at the hospital of so there's a long process of activities going on so typically from when you get and Int approved to date it is and minimum of 6 months before you see the first patients.

Entering the study simply because most institutions do not want to sign a contract they may.

Tell you that they want to work with you and do this but until the I am the IND is approved.

And the protocol has carved in stone and that signed the contract with you.

So and then it.

And then you need to go to the <unk> also so things take a long time.

And that explains that.

David Matthew Nierengarten: Yeah, yeah, it's understandable. I was just curious if there was a particular factor beyond that. Like, again, as you mentioned, the radiation approval or if it was patient availability, but that sounds like all the above. Yeah, no patient.

Yeah, Yeah. It's it's understandable I was just curious if there was of particular.

Hillary factor beyond that like you know again as he mentioned the radiation.

Approval or a.

Or if it was the patient availability, but it sounds like all of the above.

David Matthew Nierengarten: Yeah, no patient availability doesn't seem to be an issue. Okay. Thank you. Thank you, David.

Yeah, no patient availability it doesn't seem to be an issue.

Okay, great. Thank you.

Thanks, David.

Tessa Thomas Romero: The next question comes from Tessa Romero with J.P. Morgan. Please go ahead.

The next question comes from the Tessa Romero with Jpmorgan.

Please go ahead.

Tessa Thomas Romero: Hi guys, good morning, and thank you for taking our questions here. So my first one is kind of around what your latest thoughts are on how we should be thinking about the accuracy of tracking with third-party vendors such as Symphony. Should these services, over time, be expected to be tracking Danielle's accurately? And then I have one more. Okay.

Hi, guys good morning, and thank you.

Okay.

A question here on.

My first 1 of kind of around.

What your latest thoughts are on how we should be thinking at all of the accuracy of tracking with third party vendors such as Symphony and should the service over time, the expected to be tracking Daniels and accurately and then I have 1 more.

Well I mean.

Thomas Gad: I'm actually amazed that they were this close. I think they were pretty close. I think they were about 10% below our actuals. But having said that, based on the way they are actually collecting the data, there is definitely a high risk of some uncertainty. But we are trying to find out precisely how they are collecting their information.

I'm actually amazed that day, where this close [laughter] and I think they were pretty close I think there were about 10% below our.

The actual but having said that I think <unk>.

Just on the way the actually collecting the data there's definitely a high risk of <unk>.

Some of uncertainty.

But we are trying to find out precisely how they are collecting the information, but but but definitely the they did a good job of this time.

Tessa Thomas Romero: But definitely, they did a good job this time. It's hard to be more than that. Sorry, Jess.

Okay.

Okay, and it's hard to demand.

Thomas Gad: No problem; thanks, class. That's helpful. And then I guess my next question is just, I think we've discussed this before, kind of how reimbursement and formulary access been going as you move into more sites and new treatment centers. I think we've talked about kind of 10% of use going into the front line. Is this kind of what you're seeing as you're kind of moving forward here about right, or how is it looking? Well, I, I, as in,

Sorry.

No problem. Thanks, that's helpful. And then I guess my next my next question is Josh I think we've discussed this before.

And and it had reimbursement and formulary access and you move.

And 2 more sites and new treatment and.

And I think we've talked about kind of 10% of.

Going into the front line of this kind of what Youre seeing out of your kind of <unk>.

Moving forward here about right or how it goes.

Lucky.

Well I think that as we grow sales outside of the Ms Kay more and more sales and and the second line and third line setting and and I would say, we actually seeing way more sales and so the fourth line setting and then we had expected.

Tessa Thomas Romero: Well, I think as we grow sales outside of MSK, more and more sales are in the second line and third line setting. And I would say we're actually seeing way more sales in the third and fourth line setting than we had expected, because that's where many sides would start treating patients. But having looked at reimbursement issues, there are absolutely no issues. We haven't seen any issues with reimbursement, and that's been very positive.

Because that's where many sites would start treating patients, but but having looked at the reimbursement issues. There's absolutely no issues, we haven't seen any issues with reimbursement.

And and that's been very positive.

Thomas Gad: Okay, great. Thanks for taking our questions. Thank you very much.

Okay, great. Thanks for taking our question.

Tessa Thomas Romero: Thank you very much. Have a good day, too!

Thank you very much of a good data.

Arlinda Lee: The next question comes from Arlinda Lee with Canacord. Please go ahead. Hi, guys. Thanks for taking my questions. I guess I had another one on the market.

The next question comes from Arlinda Lee with Canaccord.

Please go ahead.

Hey, guys. Thanks for taking my questions I guess I had.

And another 1 on on the market.

Arlinda Lee: You just talked about how, as sites start gaining experience with this, they tend to go in a later line. Can you maybe talk about the 20 sites that are open right now? What proportion of the population do you think that covers? And then the larger sites that you're most interested in, what proportion of patients do those cover, and what do you think your penetration is right now? Thanks.

You just talked about how and start.

Gaining experience with it they tend to go on the later line can you maybe talk about the 25 day.

Opening right now what the portion of the population do you think.

That covers and then.

Largest types that you're most interested in what pushed the proportion of patients.

On the cover and what do you think of your penetration and that's right now.

Okay.

Well I think it's very difficult to give you anything precise the here.

Thomas Gad: Well, I think it's very difficult to give anything precisely here, and initially, there are 160 doctors treating patients with an opestoma in the US on a more or less regular basis. 50 of those sites are treating probably 70 to 80% of all the patients, and I would say a lot of the sites we have been skipping to belong to medium-sized sites. Whether there are 10 sites that are really choppednut sides, and until now, I think we're into two or three of these top sites.

And initially there was 160 sites.

Treating patients with no the stoma and the U S on the more or less regular basis.

The safety of those sides of treating will be.

70% to 80% of all of the patients.

And I would say.

Lot of the sites getting through is belonging to the.

Medium sized.

Sites.

And whether there is all types that are really chop and outside and until now I think range of 2 or 3 of these sites.

Thomas Gad: But a lot of it is also getting into the formulary in these hospitals, which is more laborious in the bigger hospitals than it is in the smaller hospitals. And I see that we are taking good proper care, I also have to say on the first side. The big ones are starting to use it, and I even saw that... I think it was still not toxic for the Angerangeload for now, so they had been treating or were planning to treat their first two patients with Naxidamab, and they also had experience treating patients with optersacoma, which I know for sure, for sure, is true, because they're part of our osteosacoma studies. So I think we will see this spreading out, but it takes a little time to get on the formal area in these bigger sites, and it takes a little longer than in the smaller sites.

But a lot of it is also to get into the formulary and we talked about which is more of labor some of them that they get off the shelf and it is and the smaller hospital.

And I E.

We are making good progress there I also asked the question.

Per site.

The big ones are starting to use it and even show of that.

I think about the dividend.

And so that's.

The announced that they had.

And treating of planning to treat the first 2 patients for the next set them up and they also had and you're also treating patients.

And the former which I know for true for sure is true because they are part of our Oklahoma studies.

So I think we will see this spreading out but it takes a little time to get on the formulary and these bigger sites and it takes longer than and the smaller sites.

Arlinda Lee: Great, thank you. And then on the ex-do us.

Great. Thank you and then all of that.

Arlinda Lee: That's not it. Yeah, no.

Yeah.

Thomas Gad: Yeah, no, that makes sense. It's great progress. On the X2S market, can you maybe talk a little bit about what the normal timelines are for the Chinese market? And then I think you previously mentioned that some of the, that this is a pretty large market. Can you provide additional color and how do you think the Chinese market is and whether that impacts the moms that have been traveling to other places to get treatment?

Yeah, Yeah, no that makes sense of its great progress.

On the ex Cmos and Mark can you maybe talk a little bit about what.

And what the normal timelines are for the China market and then and thank you previously mentioned from that.

The debt.

That's a pretty large market can you provide additional color on how big do you think the China market is and where there.

The impact yeah, and traveling to other places to get treatment.

Thomas Gad: Yeah, well, I would say most of the Chinese patients that we have treated have been treated by Dr. Morriside in Barcelona. I think he is up to about 100 Chinese patients that he has treated so far in the last three years.

Yeah, I would say most of the Chinese patients that would be of treated have been treated that Dr. Morris side and Barcelona.

It's up to about 100, and Chinese patients that history and until now and the last 3 years.

Thomas Gad: But the approval process in China is not something where you can get clear guidance that now you don't get a Perduvade, like we do. But I think a qualified guess is that sometime at the end of the first half next year, we should be able to get approval in China. That's our initial expectation.

But the approval process and China is not something where you can get a clear guidance and now you don't get up the <unk> day, and we do them.

But I think of qualified guesses that sometimes.

Sometimes and in the end of say the first half next year, we should be able to get an approval in China. That's our initial expectation.

Thomas Gad: Um, having said that, um, initially, you will be approved for the Chinese market, and you can sell without reimbursement. Then it takes a while to get government-funded reimbursement, and that could be another year. But that also would require you to go on strike.

Having said that.

Initially you will be on the Chinese market approved and you can sell without reimbursement and then it takes them a while to get.

Government funded reimbursement and that could be another year or so but that also require you to the.

And the go to guidance.

Thomas Gad: But having said that, it is our estimation that the Chinese market is at least two to three times as big in the number of patients as the US market. But it's also our estimation that we'll probably not be able to get more than about 20 to 25% of the price in the U.S. So, value-wise, the Chinese market could be anywhere between half of the value of the U.S. market and up to the same value as the U.S. market. But it's depending on where pricing and reimbursement ends up, but we're definitely very excited about it.

But having said that it is our guest imation that the Chinese market is.

At least 2 to 3 times, so to speak and number of patients as the.

The west market and.

And but it's also our estimation and we will probably not be able to get more than about 20% to 25% of the price and the U S. So value wise, the Chinese market could be anywhere between all of that.

The market and up to the same value of Mark.

But it's depending on where pricing and reimbursement of himself, but we are definitely very excited about this.

Thomas Gad: And as you can see from the most recent data from United Seraputics, where they had sales of about $53 million in the second quarter of the European toxin. It is estimated that about 40 to 44 million of those sales were in the U.S. That means that combined with our sales, we are looking right now at a $200 million U.S. market. But the... Price per patient and drug cost for dynotoxymab is about 40% of ours.

And as you can see with the with the most recent data from from the.

The United Therapeutics, where they had.

Sales of about $53 million and second quarter.

Toxin.

You can still estimated at about $40 million to $44 million of those.

Net sales was in the U S that means that combined with our sales and the like.

Now of the 200 million dollars' worth of market, but the.

Price per patient and drug costs for Guyana took some assets about 40% of balance.

Thomas Gad: In the other people we're looking at, in Daniela Price, the market is potentially more than $400 million per year. So the U.S. marketing itself is interesting. Then with the Chinese market, if that turns out to be in the ballpark of a couple of hundred million also, then we have really back into some very interesting markets here. And also, within countries covered by our Latin American partner, Technopharmine, and the Swiss and Europe are Eastern Europe and Russia. I think we are pretty well-poised for nice growth in the coming year.

And.

And that any of the prices of the market that potentially could be more than $400 million per year. So some of the U S marketing itself. Since the thing then with the Chinese market that comes out to beat and the ballpark of a couple of hundred million also then.

And we went through some very interesting market share and also for the income.

Countries covered by all of them.

Latin American partner, taking assignment.

And the snakes and Europe.

Eastern Europe, and Russia, I think we are pretty low poised for him and ask Brooks.

Thomas Gad: Great. Thank you very much. You're welcome, Alenna. This concludes the question-answer session. I would like to turn the conference back over to Thomas God for any closing remarks.

Come and goals.

Yeah.

Great. Thank you very much.

Youre welcome Melinda.

This concludes the question answer session I would like to turn the conference back over to Thomas for any closing remarks.

Thomas Gad: Thank you, everyone, for joining our call today. We hope you have a great day and look forward to speaking with you again.

Thank you everyone for joining our call today and.

Hope you have a great day and look forward to speaking to you soon thank you.

Thomas Gad: We hope you have a great day and look forward to speaking to you soon. Thank you. Bye.

Yes.

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

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

Okay.

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Operator: The

Okay.

And then.

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