Q3 2020 Y-mAbs Therapeutics, Inc Earnings Call
Good morning, and welcome to the Y M ABS.
Operator: Good morning, and welcome to Y-mAbs Therapeutics Incorporated's third quarter 2020 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 10-K for the fiscal year ended December 31, At this time, I'd like to turn the conference over to Thomas Gad, the company's founder, chairman, and president. Please go ahead, sir.
Therapeutics incorporated third quarter 22008 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 forward looking statements involve risks and uncertainties are not guarantees of future performance and actual results.
They 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 31st 2019, that's filed with the FCC March 12 2020.
And then the company's subsequently FCC reports.
At this time I'd like to turn the conference over to Thomas.
The company's founder Chairman and President. Please go ahead Sir.
Thank you Jerry good morning, everyone and thank you for joining us today.
Operator: Thank you, Jerry. Good morning, everyone, and thank you for joining us today. So, the third quarter of 2020 has been strong for Y-mAbs. We believe we've made significant progress in executing our strategy. Nacitamate BLA is currently under review with the FDA, as you know, and the PDUFA rate is coming up later this month. Additionally, Nacitamate has a rare pediatric disease designation, which means we are receiving a priority review voucher if Nacitamate is approved. We are also expecting to resubmit the OnBirdsMap BLA late 2020 or in the beginning of 2021. In addition, the FDA has cleared our two INDs for the lutetium-labeled next-generation ombudsman, and we expect this exciting compound to enter the clinic by the end of the year, targeting both pediatric medulloblastoma patients but also B783 positive brain metastasis in adult patients. We ended the quarter 2020 with approximately $131 million in cash.
So the third quarter was 2020 has been strong for why much Oh, we believe we've made significant progress on executing our strategy.
This isn't my P.L.A. is currently under review with the FDA, Yes, you know the PDUFA date, that's coming up later this month. Additionally, an assistant Matt.
That's a rare pediatric disease designation, which means we have receiving a priority review voucher, if unless it's much improved.
We're also expecting to resubmit the unfortunate B.L.A. late 2020 only at the beginning of 2021. In addition to U.S.J. has cleared out trying to use for.
The Lutecia play both next generation numbers come out and we expect this exciting compound to enter into the clinic by the end of that yeah.
Targeting both pediatric medulloblastoma patients, but also.
B seven athree positive brain metastasis and adult patients.
We ended the quarter at 2020 with approximately 131 million in cash.
So we believe we have a strong balance sheet to support the potential commercial launches of both <unk> and <unk>, while at the same time.
Thomas Gad: So we believe we have a strong balance sheet to support the potential commercial launches of both Mephismap and OnBirdsMap while, at the same time, continuing to advance the remainder of our development pipeline. We also believe that our CAST positions should carry us through the end of 2022, without taking into consideration any product sales or potential partnership income, which Bo will elaborate on later in this call.
Continued to advance the remainder of our development pipeline.
We also believe that our cash position should care just through the end of 2022.
Without taking into consideration any product sales for a potential partnership income, which Oh will elaborate on later on this call.
As a company we continue to work hard to stay true to our precision oncology field addressing unmet medical needs.
Thomas Gad: As a company, we continue to work hard to stay true to our position in the oncology field, addressing clear and unmet medical needs and focusing on advancing our therapies to reach the lives of pediatric patients living with rare diseases. Concurrently, I think it's very exciting to see our pipeline maturing into adult populations, such as lutetium-labeled ombretomab in adult B7H3-positive cancers. And our GD2-CD3 bispecific, which we anticipate will enter a phase 2 small cell lung cancer study later this year. We are also very pleased with the progress of both of our technology platforms, namely the Wi-Fi clone bispecific platform.
And focusing on advancing all therapies to read the lives of pediatric patients living with rare disease.
I'm currently I think it's very exciting to see our pipeline maturing into adult populations.
Yes look see some labeling birch, Matt and I don't be 73 positive cancers.
And our GT to Cdthree by specific which we anticipate will enter a phase two small cell lung cancer study later this year.
We also are very pleased with the progress of our folks off out tick technology platforms, namely the white bikes don't buy specific platform where.
Well, we also have a CD 33, cdthree by specific plans to go into clinic for pediatric and adult patients next year.
Thomas Gad: We also have a CD33-CD3 bispecific plan to go into clinic for pediatric AML patients next year. And our self-assembly, disassembly, radiopharmaceutical platform, also referred to as SADA, or liquid radiation, as we like to call it. Today you'll hear remarks from Dr. Klaus Merlau, our Chief Executive Officer, who will provide a business overview, and from Bo Kruse, our Chief Financial Officer, on our third quarter financial results, and I'm pleased to hand over the call to Klaus for that. Thank you. Thank you very much, Thomas, and welcome to Y-mAbs Therapeutics' third quarter 2020 earnings call. We're very pleased that you have chosen to spend this morning with us.
And our self Assembly. This assembly radiopharmaceutical platform also referred to as Sato or liquid radiation that we like to call them.
Today, you will hear remarks from Dr., Charles Murray law, what she's Chief Executive Officer, who will provide a business overview and Trump or Cruz, all Chief Financial Officer.
On our third quarter financial results and I'm pleased to hand over the call to close that thank you.
Thank you very much Thomas and welcome to why maps that you had excess sort of caught up 2020 earnings call.
I'm very pleased that you have chosen to spend this morning with us trying to sort of quota. We have continued to work hard to ensure that our pipeline, including our lead candidates next set them up in about a month and wants to what the markets.
Klaus Merlau: During the third quarter, we have continued to work hard to ensure that our pipeline, including our lead candidates Nexidimab and Ompertimab, advances toward the market. As you know, back in June, the FDA accepted our BLA for Accetamide for Treatment of Patients with Relapsed Refractory High-Risk Noble Stoma for Priority Review. The FDA set up a due date of November 30, 2020, and the agency also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.
As you know back in June the FDA has had except that will be laid for next set them up for treatment of patients with relapsed or refractory Hyvisc no stone up a priority review the FDA set up in Twoq to date on November Thirtyth 2020, and the agency also indicated that and it be are they finding communication data that.
It is not currently planning to hold an advisory committee meeting to discuss the application.
If approved we expect that this indication will be approved under accelerated approval based on the overall response rate and duration of response.
Klaus Merlau: If approved, we expect that this indication will be approved under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may then be contingent upon verification and description of clinical benefit in a post-marketing commitment. We expect that the confirmatory post-marketing clinical trial required to verify and describe clinical benefits will be study 201, which is already ongoing. Study 201 will then have to enroll a total of more than 80 patients and measure overall response rates, ORR, progression-free survival, and overall survival. ORR is the primary endpoint of the study.
Continued approval for this indication may then be contingent upon verification that description of clinical benefit in a post marketing commitment we expect that the confirmatory post marketing clinical trial, but glad to verify and describe kind of call benefit will be the study Joel one which is already ongoing study to Orion will then have.
To enroll a total of more than 80 patients and make sure all response rates Oh, a progression free survival and overall survival.
The Oh as the primary endpoint of the study that progression free survival and all said either secondary endpoints into long term taught a lot.
Klaus Merlau: The progression-free survival and overall survival are secondary endpoints in the long-term follow-up. Nexidimab has received priority review, often drug breakthrough therapy, and rare fetal disease designations from the FDA. And upon potential approval, we believe Noxetamab will be a much-needed breakthrough for patients with venastafacturin or opostoma who historically have not had any approved treatment available. At the International Society of Pediatric Oncology Virtual Congress in October this year, otherwise known as SIOP, Dr. Mora from SJD Barcelona Children's Hospital presented data from the company's Pivotal 201 multicenter study. The central independent evaluation showed an overall rate of response of 68%, and the rate of complete responses was 59% for the 22 patients presented. In addition, bone marrow clearance was observed, with complete responses in 7 of 9 patients who had positive bone marrow at trial start. The median duration of responses for long-term follow-up was, at the time of the conference, 27 weeks.
Next hit 'em up has received priority review all.
Often dropped breakthrough therapy, and raffi dag to seize designations from the FDA and up on potential approval. We believe that set them up will be a much needed breakthrough for the patients with Astra factor into that but still not who historically not have had any approved treatment debatable.
At the International Society of pediatric oncology World Congress in October this year, otherwise known as it's I O P dumped a mora from S.J.D. basketball not children's hospital presented data from the company's pivotal jewel one multicenter study.
The central independent evaluation killed and all rate of a sponsor of 68% and the rate of complete responses was 59% for the 22 patients presented in addition bone marrow Terence was observed.
Cleat response in seven of nine patients who had positive bone marrow at trials that the median duration of responses for long term follow up was at the time of the conference 27 weeks.
In addition to be like the BLE for next set them up in relapsed refractory in Opus Stoma, we have trials ongoing in Barcelona and at Memorial Sloan Kettering in New York for first line go up the stone mountain as well as chemo combination trials for all the facts right almost all patients.
Klaus Merlau: In addition to the BLA for nuxetamab in relapsed refractory neuroblastoma, we have trials ongoing in Barcelona and at Memorial Sloan Kettering in New York for first-line neuroblastoma, as well as chemocombination trials for refractory neuroblastoma patients. Now, we turn to Ambertumab, our second lead compound. In October, we received a refusal letter from the FDA regarding the BLA for Ambertumab for the treatment of pediatric patients with CNS-leptomeningo-metastasis from noblestoma. Our BLA was originally submitted in August 2020. Upon its preliminary review, the FDA determined that certain parts of the CMC module and the clinical module of the BLA required further detail.
Now turning to him, but I'm Oh second lead compound in October we received every fusion to five letter from the FDA regarding that be life on burden that for the treatment of pediatric patients with CNS leptonic them metastasis from now but still.
Oh, yeah. They wasn't originally submitted in August 2020 upon its preliminary revenue the FDA determined that certain parts of the CMC module and the clinical thought you'll have to be at eight required for the detail.
No additional nonclinical data have been requested or are required and it should also be noted that no additional clinical trials.
Klaus Merlau: No additional non-clinical data have been requested or are required, and it should also be noted that no additional clinical trials of additional patients were requested in the. Y-mAbs is confident that it can address all points raised by the FDA, including providing the requested additional CMC information and supplementary data from Study 101, which will include response data from patients with a valuable disease among the patients included in Protocol 101. In addition, in an oral presentation at SIARP, Dr. Kim Kramer from MSK presented interim results for 17 patients enrolled in the company's Pivotal 101 multi-center study. The study showed a 12-month overall survival rate of 87 percent with a median follow-up of 26 weeks. This compares very favorably to an OS of approximately 30% in a historical control group.
For additional patients was requested to ending reps.
Refuse to file later, well I'm EPS is confident that it can address all points raised by the FDA, including providing that requested additional CMC information and supplements every data from study one a one which will include response data from patients with it that it will disease. Among the patients included in total called one on one.
In addition, an oral presentation that syrup dr. <unk> at an old presentation that SAP Dr. Kim Kramer from M.S.K. presented interim results for 17 patients enrolled and the company's pivotal one to one book to send to study. The study showed a 12 months overall survival rate of 87%.
The median follow up of 26 weeks. This compares very favorably to the UN always off approximately 30% in a historical control group the.
The preliminary all survival data results from the multi center study, one or one encouraging and appears almost identical. So the results of study Oaktree lunch retreat, which was conducted at them Washington Kettering why recruitment is still ongoing we have very pleased to see the preliminary I'm talking about data in the multi center city.
Klaus Merlau: The preliminary oral survival data results from the multicenter study 101 are encouraging and appear almost identical to the results of study 03133, which was conducted at Memorial Sloan Kettering. While recruitment is still ongoing, we are very pleased to see the preliminary results on Berta in the multicenter setting that appears to support the conclusions from the MSK data. We believe the preliminary survival curves are very similar to the original MSK data, and this is good news for children with CNS leptomaniac metastasis from the upper stomach.
That appears to support the contributions from the M.S.K. data. We believe the preliminary survival curves are very similar to the original M.S.K. data and this is good news for children with CNS Leptonic metastasis from Delta still Matt.
As previously disclosed we are also developing a button that put the juice intrinsic primetime like no.
Klaus Merlau: As previously disclosed, we are also developing on BertaMAP a diffuse-intrinsic pontine glioma known as DIPT in a Phase 1 study at MSK. And we are planning to open a multi-center Phase 2 study for DIPT patients this year. For desmoplastic small round cell tumors, known as DSSR-CT, we recently opened a Phase 2 study at Memorial Sloan Kettering. Let's now turn to the Lutetium Label Humberto map. In October, the FDA cleared our IND for 177 lutetium ombudsman DTPA for the treatment of medulloblastoma, which is one of the most common types of primary brain cancer in children. Medulloblastomas are invasive, rapidly growing tumors that, unlike most brain tumors, spread through the cerebrospinal fluid and subsequently metastasize to different locations along the surface of the brain and the spinal cord.
No one has T.I.P.T. in a phase one study at M.S.K. and we are planning to open a multi center phase two studies for the I P. T patients this year.
That's my plastic small round cell tumors known as the EPS. This I see we recently opened a phase two study at Memorial Sloan Kettering.
Let's now turn to the Cheecham label them, but tomorrow.
In October the FDA cleared how I N D for 177 decision on both of my P.G.P.A. for treatment of Metolachlor still not which is one of the most common types of primary brain cancer in children.
But do look the stillness I invasive rapidly growing tumors that unlike most plain too much spread through the sample of spinal fluid and subsequently metastasized to different locations along the surface of the brain and the spinal cord.
177 to teach them on both of my P.T.A. embodies the company's naked a button up antibody radio labeled with the Cheecham bunch 77, using D. P. H a key late there to teach them I can read you I said two to the antibody we.
Klaus Merlau: 177 Lutetium Umbertumab DTPA embodies the company's naked Umbertumab antibody, radio-labeled with 177 Lutetium, using DTPA to chelate the 177 Lutetium radioisotope to the antibody. We anticipate that an international multi-center Phase I-II clinical trial will be initiated for the screening of pediatric patients with dulloplastoma during this quarter after the opening of the IND. And based on our clinical experience with iodine-131 ombudsman for B7H3-positive brain metastasis, we are obviously excited to see the 177-lutetium construct make its way into the clinic to potentially establish a safety profile and determine the maximum tolerated dose in these patients. In this study, we hope to leverage our clinical experience from treating 27 medulloplastoma patients with the iodine-131 ombudsman, again using indwelling catheters for intracerebral ventricular drug delivery, also known as the Omaya catheter.
We anticipate that an international multicenter phase one two clinical trial will be initiated and initiated for the screening of pediatric patients with build up is still maturing this quarter. After the opening up the <unk> and based on our clinical experience with ire Dean One study won a bunch of my Toby seven eight street positive brain metastasis.
We are obviously excited to see the once they went to seven to teach them kind of struck make its way into the clinic to potentially establish a safety profile and to determine the maximum tolerated dose and these patients in this study we hope to leverage our clinical experience from treating 27 medulloblastoma patients with the 13 once 31 numbers on that.
Against <unk> again, using indwelling catheter sport into sample then trigger electronic delivery also known as the <unk> Canada.
In addition, the FDA has recently cleared our separate I Indeed for basket trial in B seven eight street positive CNS, let somebody can metastasis, Kansas in adults, where we hope to leverage our prior experience from treating more than 25 adults with Irene once or do you want a button that we.
Klaus Merlau: In addition, the FDA has recently cleared our separate IND for a basket trial in B7H3-positive CNS leptomeningo-metastasis cancers in adults. Well, we hope to leverage our prior experience treating more than 25 adults with iodine-131 on BertaMask. We expect to initiate the study for the first adult patients to be treated with 177 lutetium on the bottom of DTPA during the fourth quarter of 2020, and we are thrilled to widen our clinical reach to include adult indications. Now, let's talk about nivotrozumab, our GD2, CD3 bi-specific antigen. In September, the FDA granted orphan drug designation and rare pediatric disease designation to our leading bispecific antibody, nivotrotumab, for the treatment of neuroblastoma. Nivotrotumab is a humanized anti-TD2 bispecific antibody in phase I-II clinical development in collaboration with MSK in patients with relapsed refractory neuroblastoma, as well as high-grade osteosarcoma and other TD2-positive solid tumors where patients have relapsed or are refractory to previously known standard therapy.
We expect to initiate the study for the first adult patients to be treated with one seven to seven looks he shouldn't a bunch about TCPA during the fourth quarter up 20, 2020, and we are trying to widen our clinical reach to include adult indications.
Now, let's talk about neither trust them up or do you do to Cdthree by specific antibody in September the FDA granted orphan drug designation and rare pediatric disease Disick nation to our leading by specific antibody neither towards them up for the treatment of snow, but still not never tried them up is a humanized anti <unk>.
By specific antibody in a phase one two clinical development in coverlet collaboration with M.S.K. in patients with relapsed refractory I know, but still not at school, that's high grade Osteosarcoma and I'll, let you get to positive solid tumors, where patients have relapsed or refractory to previously known to stand up a therapy.
We plan to expand the ongoing study of need for trucks them up into two separate phase two arms, one and opus DOUMA and one in osteosarcoma as well as initiating a separate phase two multi center study in small cell lung cancer, we expect to submit Eni and de for the lung cancer study during the fourth quarter Twentytwenty.
Klaus Merlau: We plan to expand the ongoing study of nivotrotumab into two separate Phase II arms, one in norepistoma and one in osteosarcoma, as well as initiate a separate Phase II multicenter study in small cell lung cancer. We expect to submit an IND for the lung cancer study during the fourth quarter of 2020, and we are excited to widen nivotrotumab's clinical reach to Turning to the commercial aspects, we are targeting the small universe of pediatric cancer centers that treat the majority of neuroblastoma patients. We believe that we have built a lean and highly targeted commercial organization ahead of the launch of both Naxidomab and Ombetamab, if approved. Assuming approval of Naxidomab, our commercial team is in place and ready to launch Naxidomab within a few weeks of its approval in the U.S., and we believe we are also well-positioned for the launch of Ombetamab, if approved, in the U.S.
And we are excited to widen to the Trojan loves clinical reach to include adult patients also.
Turning to the commercial aspects, we are giving a small universe of pediatric cancer centers and agree that treat the majority of the new up customer patients. We believe that we have built at lean and highly targeted commercial organization ahead of the launch of both next set them up and a better tomorrow.
If approved assuming approval of an accident that our commercial team isn't planes place and ready to launch next set him up within a few weeks of its approval in the U.S. and we believe we are also better positions for the launch of them put them up if approved in the U.S. European marketing application pump button map is potentially only a few months behind that.
Klaus Merlau: The European marketing application for Ombetamab is potentially only a few months behind the U.S., and we plan to begin staffing our European commercial organization in the next few months. And then on to our exciting SADA technology As you will recall, in April, we entered into an agreement with Memorial Sloan Kettering Cancer Center and Massachusetts Institute of Technology for a worldwide exclusive license and research collaboration to develop antibody constructs based on the SADA radio immunotherapy platform. The SATA technology's two-step payload delivery has been shown in an in vitro setting to shrink or completely eliminate tumors in vivo in animals while other tissues were spared. No clearing agent was needed, and no significant toxicity to bone marrow, kidney, or liver tissues were observed.
Yes, and we plan to begin staffing all European commercial local news organization in the next few months.
And then onto our exciting sort of technology as you will recall in April we entered into an agreement with them All Sloan Kettering Cancer Center, and Massachusetts Institute of Technology for worldwide exclusive license and research collaboration to develop antibody constructs based on this out of reach <unk>.
Immunotherapy platform.
The SATA technology, it's Tuesday payload delivery has been shown in an in vitro setting to shrink.
Ought to completely eliminate two mous also in vivo in animals, while other tissues were spared no.
No clearing agent was needed and no significant toxicity to that bone marrow kidneys and liver tissues were observed we believe that the SATA technology may allow for rapid clearance of the compound, while maintaining high ticket uptake and thereby causing less immunogenicity.
Klaus Merlau: We believe that the SATA technology may allow for rapid clearance of the compound while maintaining high target uptake and thereby causing less immunogenicity. In addition, the SATA technology appears to be modular, whereby any DOTA-modified radioactive payload combined with any therapeutic antibody seems possible. We are excited about the prospects of the SATA technology, and thus far, we have announced four SATA targets in preclinical development. This includes our newest construct, B7H3 SATA, which we intend to use for the treatment of prostate cancer. We plan to submit the first IND for a SATA construct in the second half of 2021, and we have high hopes to see liquid radiation transform today's cancer treatment. Finally, a few more general comments. To support our growth plans, we increased our headcount by 25 to a total of 114 employees during the quarter.
In addition, this out of technology appears to be modular whereby any dota modified radioactive payload combined with any therapeutic antibody seems possible. We are excited about the prospects. After some technology and thus far we have announced for SATA targets in preclinical development. This includes our newest.
Construct D. Seven eight street data, which we intend to use for treatment of prostate cancer. We plan to submit the first I'd for SATA construct and the second half of 2021, and we have high hopes to see liquid radiation transforms todays cancer treatments.
Finally, a few more general comments to support our growth plans, we increased our headcount about by 25 to a total of 114 employees during the quarter.
Due to the recruit recruitment of sales force and supporting functions. The increase is significant compared to recent quarters.
Klaus Merlau: Due to the recruitment of Salesforce and supporting functions, the increase is significant compared to recent quarters. With the PDUFA date for Nexidermab coming later this month and a planned resubmission of the Umbertumab DLA coming up, we believe that we are well positioned to transform Y-mAbs into a commercial state company. Concurrently, we plan to widen and deepen our pipeline by advancing our antibody constructs through the clinic, predominantly the SARTA constructs, the bi-specifics, and the next generation of birth-to-life radio-labeled antibodies. With that in mind, now, I turn over to Bo and invite him to share his remarks on the second quarter financials. Bo?
With that produce the data for an exit it must coming later this month and the planned resubmission of the person might be late coming up we believe that we are well positioned to transform BIME EPS into a commercial stage company.
I'm currently we plan to widen and deepen our pipeline by advancing our antibody constructs through the clinic predominantly decide to construct the bi specifics and the next generation of buttoned up regulate with antibodies.
Well, there's now let me turn over to Bo and invite him to share his remarks on the second quarter financials, though right.
<unk>, we reported a net loss for the quarter ended September Thirtyth, 2020, $32.8 million or 82 cents per share basic and diluted compared to a net loss of 23.9 million or 70 cents per share basic and diluted for the quarter ended September Thirtyth 2019.
Bo Kruse: Thank you, Klaus. We reported a net loss for the quarter ending September 30th, 2020 of $32.8 million, or $0.82 per share, basic and diluted, compared to a net loss of $23.9 million, or $0.70 per share, basic and diluted, for the quarter ending September 30th, 2019. We entered the third quarter with a cash position of $131 million compared with the 2019 year-end cash position of $207 million. As our work on the Umberto Mapp BLA submission progressed through the quarter, and as we continue to accelerate the commercial ramp-up for the potential launches of Nexidimap and Umberto Mapp, we've seen our cash burn increase. We expect that the cash burn from operating expenses for the fourth quarter of 2020 to increase slightly but remain roughly in line with the third quarter.
We ended the third quarter with a cash position of 131 billion compared with the 2019 year end cash position of 207 million.
That's how we're going to do but it may not be a late submission has progressed through the quarter and as we have continued to accelerate the commercial ramp up for the potential launch itself next see them up on Burma, we've seen our cash burn to increase we expect that the cash burn from operating expenses for the fourth quarter in 2020 to increase slightly but remained roughly.
With the third quarter.
As we take a closer look at the operating expenses for the third quarter, we know that research and development expenses have increased by 1.3 million from 19.7 million for the quarter ended September Thirtyth 2019 to 21 million for the quarter ended September Thirtyth 2020. This.
Bo Kruse: As we take a closer look at the operating expenses for the third quarter, we note that research and development expenses increased by $1.3 million, from $19.7 million for the quarter ended September 30, 2019, to $21 million for the quarter ended September 30, 2020. This increase was primarily attributable to a $2.4 million increase in personnel costs, half a million dollar increase in clinical trials, and $0.4 million increase in professional and consulting fees. These increases were partially offset by a decrease of $2 million in outsourced manufacturing.
This increase was primarily attributable to a $2.4 million increase in personnel costs half a million dollar increase in clinical trials and point $4 million increase in professional and consulting fees. These increases were partially offset by a decrease of $2 million in outsourced manufacturing costs.
DNA expenses increased by 6.9 million from 4.7 million for the quarter ended September Thirtyth 2019, So 11.6 million for the quarter ended September 32020 <unk>.
Bo Kruse: DNA expenses increased by $6.9 million from $4.7 million for the quarter ended September 30, 2019, to $11.6 million for the quarter ended September 30, 2020. The increase in DNA expenses primarily reflected a $2.2 million increase in personnel costs, $3.2 million increase in expenses for the building of our commercial infrastructure related to the potential launch of our two lead product candidates, and $1.6 million for business insurance and professional development. Cash used in operating activities as of September 2020 shows that the cash flow increased by $24.6 million from $48.9 million for the nine-month period ended September 30, 2019 to $73.5 million for the period ended September 30, 2020. The increase was primarily caused by an increase in the net loss for the period.
The increase in <unk> expenses, primarily for figure 2.2 million dollar increase in personnel cost $3.2 million increase in expenses for the building of our commercial infrastructure related to the potential launch of our two lead product candidates and axiom of 'em better map and 1.6 million for business insurance and professional fees.
Cash used in operating activities is as per September two.
2020 show that the cash burn increased by 24.6 million from 48.9 million for the nine months period ended September Thirtyth 2019, So 73 and a half million for the period ended September 32020. The increase was primarily caused by the increase in the net loss for the period.
The net loss itself increased by 41, and a half million for the period ended September 32020, and was partially offset by an increase in non cash expenses, including depreciation and stock based compensation was 16.9 million.
Bo Kruse: The net loss itself increased by $41.5 million for the period ended September 30, 2020 and was partially offset by an increase in non-cash expenses, including depreciation and stock-based compensation of $16.9 million. If Nexidimab receives approval from the FDA, we'll receive our first PLV. Under the terms of the MSK License Agreement, we are obliged to monetize the PFE and share the net proceeds thereof, if any. William S. Kaye, who will receive 40% of the net proceeds, and the remaining 60% is going to us. We've entered into an engagement letter with a leading institution in the field of monetizing PAVs and, assuming FDA approval of Nexisma, expect to complete a transaction either late 2020 or in the beginning of 2021. It's worth noting that we also have received the Epidiotic Disease Designations from BertaMap, NeopetrozaMap, and the GD2, GD3 vaccine.
If next to them I've received approval from the FDA will receive offers PRB under the terms of the as key license agreement.
We applies to monetize the PSV and she hasn't it proceeds there all I mean, we didn't Miss Kay who will receive 40% of the net proceeds and the remaining 60% is going to us.
We've entered into an engagement letter with a leading institutions in the field of monetize mpsvs and assuming FDA approval of next season and expect to complete a transaction either late 2021 that being 2021 as.
It's worth noting that we also have received for epigenetic deceased assignations from Burma units.
Rosemont and the GT two discrete vaccine so upon the potential approval of these compounds would have another three P.M. east coming.
In terms of financial guidance since the secondary offering last year. It was said that the cash on hand would cover operating expenses and capital expenditures through the fourth quarter of 2022. This does take into account the potential net proceeds corners, I'd say sales mix see them I'm, Adam, but RPM east, but does not take into.
Bo Kruse: So upon the potential approval of these compounds, we'll have another three PAVs coming. In terms of financial guidance, since the secondary offering last year, we've said that the cash on hand would cover our operating expenses and capital expenditures through the fourth quarter of 2022. This does take into account the potential net proceeds from the monetization of the Naxidomab and Mbertumab POVs but does not take into account any revenues we may receive from the commercialization of either Naxidomab or Mbertumab upon their potential approval or the proceeds we may receive from any potential future partnerships. Thus, we continue to believe Y-mAbs remains in a very healthy financial position. This concludes the financial update, and I'll now turn the call over to Thomas. Thank you, Bo.
Any revenue as we may receive from the commercialization of either exceeded my own burden my coupons that potential approval or the proceeds we may receive from any potential future partnerships. So we continue to believe well I'm EPS remains in a very healthy financial position.
This concludes the financial update and I'll now turn the call over to Thomas.
Thank you go Oh excuse me.
Okay. This concludes the remarks of offer for repair.
Prepared remarks today I think at this time, we will let the call go over for questions to Jerry Let's open up any sure nice session. We have right now thank you.
Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, you make star two if you'd like to remove your question from the Q.
Thomas Gad: Okay, this just concludes our presentation. Thank you all for your prepared remarks today. I think at this time we will let the call go over for questions to Jerry and let's open up any Q&A session we have right now. Thank you.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, where multiple baseball we poll for questions.
The first question is from Robert Burns H.C. Wainwright. Please go ahead Sir.
Operator: We'll now be conducting a question-and-answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. You may press star 2 if you'd like to remove your question from the queue.
Hi, guys. Thanks for taking my questions and congrats on the quarter three for me right now if I'm right.
So for the first one one of the reasons cited by the F. did for their freezes or so file letter or was that they were question direct evidence of anti tumor activity I mean, I E response rate data before proceeding with the filing now. Unfortunately, we did not see any response rate data from the phase two multicenter study ever worried about presented Psi ops, despite it being.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions. The first question is from Robert Burns, H.C. Wainwright.
Robert John Burns: Please go ahead, sir. Hi guys, thanks for taking my questions and congrats on the quarter. Three from me right now, if I may.
The secondary endpoint can you provide any color at a level of responses seen in that trial and is the opinion looking for a minimum of specific response level here.
Klaus Merlau: So for the first one, one of the reasons cited by the FDA for the refusal to file letter was that they requested direct evidence of anti-tumor activity, I mean, i.e., response rate data, before proceeding with the filing. Now, unfortunately, we did not see any response rate data from the Phase II multicenter study of Invertimab presented at SIOP, despite it being a secondary endpoint. Could you please provide in color the level of responses seen in that trial, and is the FDA looking for a minimum specific response level? So yeah, let me start by replying to this.
So yeah, let me start type decline to this well we have not presented the data yet and be discussing to what level than how much. The if they want to see I can assure you that we are definitely having the groups of patients that are showing measurable disease and that'd be awesome.
Being responses in these patients.
It looks like right now that maybe about 40% of the patient has measurable disease, but we'd still a little early to say, how many people will be able to detect michel to cease and deploy potential tumor responses on but but we are definitely seeing responses and I'm feeling comfortable that that level of responses will be able to present will be satisfactory.
Klaus Merlau: While we have not presented the data yet and we're discussing what level and how much the FDA wants to see, I can assure you that we are definitely having a group of patients that are showing measurable disease and that we are seeing responses in these patients. It looks like right now that maybe about 40 percent of the patients have measurable disease, but it's still a little early to say how many we will be able to detect measurable disease and look for eventual tumor responses. But we are definitely seeing responses, and I'm feeling comfortable that the level of responses we will be able to present will be satisfactory to the FDA when we agree on all the details of the refiling.
The FDA I wouldn't be agree on all the details I said be filing.
Okay. Thanks, a lot.
And my second question.
It's around the live TV on 177 label and burned about now considering that live Tdm. One time. This happens maximum beta particle energy is not doesn't seem that much lower than iodine 131, how reasonable do you believe it is that you may see a relatively similar efficacy benefit between the 177 label.
Burden lab as compared to the one eye on 131 labeled and burn up and what's in the market sizes looked like for it to be something these three positive, but that's still a bust on that as far as the peace have any stay positive CNS Mets for tumors and adult patients.
Klaus Merlau: Okay, thanks. So my second question is about the Lutetium-177 labeled InverteMAP. Now considering that Lutetium-177's maximum beta particle energy is not, doesn't seem that much lower than Iodine-131, how reasonable do you believe it is that you may see a relatively similar efficacy benefit between the 177-labelled InverteMAP as compared to the one containing Iodine-131? And what do the market sizes look like for the B7H3-positive medulloblastom Well, I mean, the lutetium is correct, it has an energy of about 80% of the electrons of the lutetium that are thrown off are about 80% of the energy of electrons thrown off an iodine, so they're pretty similar.
Well I mean, the teach him is correctly. It it has an energy of about 80% of the the editor films of the to teach him that throwing off is about 80% of the energy at ACTRIMS drawn off and I are dean so so they're pretty similar half life of the two isotopes also produced similar five to six days for Q4.
That it's each of them and maybe seven days for the team and and so so that also tells you that the penetration and tissues. It's almost like I'm in the same ballpark with that she should maybe be about 70, 80% penetration and damaging wishes I'd and therefore, if you believed that it should be possible.
So to to up the dose a little bit of that in the <unk> versus the or most of the IDN. Once anyone big benefit is that it's a lot easier to Rachel labor with the other teach them on on the beach <unk> dated antibody constructs.
Klaus Merlau: The half-life of the two isotopes is also pretty similar, five to six days for the lutetium and maybe seven days for the iodine, and so that also tells you that the penetration in tissues is almost like in the same ballpark, where lutetium may be about 70-80% penetration and damaging versus iodine, and therefore, we believe that it should also be possible to up the dose a little The big benefit is that it's a lot easier to regulate with the lutetium on a DTP-A-chelated antibody construct. Size of the market, I mean, it's very difficult, but for adults and pediatrics, medulloblastoma is about 350 kids per year in the U.S., so that's the ballpark size of the medulloblastoma indication, but for the adult indication, we're looking at tens of thousands of patients per year dying from CNS-leptomaniacal metastasis with B7H Last one for me, and then I'll hop back in the queue.
Size up the market I mean, it's very difficult.
But but a full for the adults for the pediatrics. The medulloblastoma, there's about 350 kids per year in the U.S. So so up so that's the ballpark size up off the muddled up is still my indication, but the adult indication. We're looking at tens of thousands of patients per year dying from CNS, let somebody got metastasis would be seven athree positive cancer.
Yes.
Okay. Thanks for that class a last one for me and then I'll hop back in the queue. So given the proximity to an FDA approval for an accident maben EPS refractory neuroblastoma could you discuss a little more in detail now how you're currently viewing the regulatory path and timelines for potential label expansion into the frontline setting as well as for the heads.
Protocol.
Yeah well.
I think the what we have said all along and what I'm still saying is let's let the FDA approved mek set them up then the idea is to ask for a type B meeting I go back and discuss what do they need to see for frontline study and then so let's have that type B meeting with the agency. After we have gotten the approval and that but as you know we have to single center ongoing.
Klaus Merlau: So, given the proximity to an FDA approval for oxidamab and relapsed refractory neuroblastoma, could you discuss a little more in detail now how you're currently viewing the regulatory path and timelines for potential label expansion into the frontline setting, as well as for the HITS protocol? Yeah, OK. I think what we have said all along and what I'm still saying is, let the FDA approve Nexidermab, then the idea is to ask for a type B meeting and go back and discuss what they need to see for a frontline study. And then, so let's have that type D meeting with the agency after we have gotten the approval. But as you know, we have two single center ongoing frontline studies already. We presented the first set of data from Dr. Morris' frontline study about 11 months ago.
Frontline studies already we have already presented the first set of data from Dr. Morris Frontline study about 11 months ago.
And the MSK study is almost completely enrolled it's supposed to enroll 59 patients.
And so very soon we should also have data for that so when we go to the FDA, we will be able to bring data from two separate clinical studies in the front line and ask them about the potential to sign up and most its interface frontline study phase two and.
Find out what more do they need to see but as I said, let's get the approval for an exit them up in second line and the same goes for the chemo combination. That's also a discussion we would like to have with the FDA for them to expand to label into the chemo combination what more is needed because we as also as you know we have a combination study with.
She can temozolomide and GM CSF and next set them up at both MSK and again, a single center study in Spain investigator sponsored by dumped up a lot of that so so and be at planning for additional studies in that setting also.
Klaus Merlau: And the MSK study is almost completely enrolled. It's supposed to enroll 59 patients, and so very soon, we should also have data for that.
Klaus Merlau: So when we go to the FDA, we will be able to bring data from two separate clinical studies and frontline and ask them about the potential design of a multi-center phase frontline study phase two, find out what more they need to see. But as I said, let's get the approval for Naxetamab second line. And the same goes for the chemocombination.
So that's where we are now we need to talk to the FDA get clear regulatory guidance from their side, rather than us, saying is getting what they actually need but we have data and we are definitely planning to meet and get that.
Awesome. Thank you class I'll hop back in the Cat in Glasgow.
Thanks.
The next question is from David Lebowitz Morgan Stanley. Please go ahead Sir.
Thank you very much for taking my question.
Klaus Merlau: That's also a discussion we would like to have with the FDA, for them to expand the label into a chemocombination, what more is needed. Because we also, as you know, we have a combination study with irinotecantamisolamide and GM-CSF and Naxetamab at both MSK and again, a single center study in Spain, being investigated, sponsored by Dr. Morales. And we are planning for additional studies in that setting also. So that's where we are now.
Given that an accident habits is going to be potentially launch very soon could.
Could you just run us through I guess, what we should look for in an initial launch.
I guess the revenue growth could we see it going into the first market opportunity is clearly on the smaller side and what are your sales organization looks like at this point.
Sure I mean, as you know David most companies are very cautious on predicting on sales when launching a new product and and so what are we having said that we know there's about 300 kids that year that that primary or secondary refractory noticed on patients and right now they don't have any approved therapy. So so.
Klaus Merlau: We need to talk to the FDA, get clear regulatory guidance from their side, rather than us second-guessing what they actually need. But we have data, and we are definitely planning to meet and get that. Awesome. Thank you, Klaus.
So those are the ones that we are going to start taking.
Taking into and making our customers, but but how many we will reach let's let's get the product approved we will launch and and let's see how it develops and in the first year, but but to be a definitely very excited we have very strong expectations. We also have a very strong collaboration with them awesome.
Klaus Merlau: I'll hop back into Q&A. Congratulations again. Thanks. The next question is from David Leibovitz, Morgan Stanley. Please go ahead, sir.
David Matthew Nierengarten: Thank you. Given that Nexidimab is going to be potentially launched very soon, could you just... So, for an initial launch, what type of revenue growth could we see? I mean, the first market opportunity is clearly on the smaller side.
Thanks still as you can hear from everything that I think every second paragraph I hope she was saying at almost a one reference to collaborations with M.S.K. and they are very committed to using next at a map and that being using it goes in front line and second line answered line no bust on the patients and in various combination so as monotherapy for that for the last five.
Klaus Merlau: Sure. I mean, as you know, David, most companies are very cautious about predicting sales when launching a new product. And so, having said that, we know there are about 300 kits a year that are primary or secondary refractory neuroblastoma patients, and right now, they don't have any approved therapy. So, those are the ones that we are going to start digging into and treating as our customers. But how many we will reach, let's get the product approved, we will launch, and let's see how it develops in the first year. But we are definitely very excited. We have very high expectations.
Five years, so so they.
They would obviously continue doing that even if it's next set them up becomes a commercial product rather than a clinical development program. So so in in terms of ups. The sales team be happy hour 10 people in the sales organization those that actually responsible for visiting doctors.
Klaus Merlau: We also still have a very strong collaboration with Memorial Sloan Kettering, as you can hear from everything that I think every second paragraph I was using had almost one reference to collaborations with MSK. And they are very committed to using Nexidermab and have been using it both in front line and second line and third line for neuroblastoma patients and in various combinations or as monotherapy for the last five years. So, they would obviously continue doing that even if Nexidermab becomes a commercial product rather than a clinical development program. So, in terms of the sales team, we have 10 people in the sales organization who are actually responsible for visiting doctors. They are all in place.
They all in place we have our medical science license and research nurse team also set up and ready to go and of course the whole additional.
Additional support organization with the market access and marketing and a co pay et cetera. All this has also been set up and ready to go. So everybody is extremely excited these days and and then continuously monitoring for any final and new development and I'm very confident that that we have there.
Those to a potential marketing authorization for an exit them up.
Thank you for that and looking over to the burden that franchise could you just I guess discuss the the challenges of.
Klaus Merlau: We have our medical science license and research nurse team also set up and ready to go. And, of course, the whole additional support organization with market access and marketing and co-pay, etc. All this has also been set up and ready to go. So, everybody is extremely excited these days and continuously monitoring for any final and new developments. And I'm very confident that we are very close to a potential marketing authorization for Nexidermab. And looking over to the VirtaMap franchise, could you just, I guess, discuss the challenge, how that dynamic could differ between the IADF? Well, I think it's more of a productivity issue.
Having such a therapy being prescribed by I guess radio pharmacies at the hospitals and how that dynamic could differ between the iodine and the the Tcten bird.
Well I think it's it's more kind of a productivity issue right now there what we are planning for and as a part of hobby allay Oh, suggesting is that we are responsible for the radio labeling of the unbilled them up with the idea so that means that our central radio labeling is happening.
We're releasing that ready to use product.
Klaus Merlau: Right now, what we are planning for, and as part of our BLA, are suggesting is that we are responsible for the radio labeling of Onbertumab with iodine. So that means that our central radio labeling is happening. We are releasing the ready-to-use product, with a potential use within 72 hours. And so the only thing that radiopharmacy at the hospital needs to do, and that is a requirement for the hospital, so they need to have a radiopharmacy, but any large hospital in the U.S. has that, and definitely all the hospitals treating pediatric oncology. So the only thing that the radiation pharmacy needs to do is to receive the radio-labeled antibody in the little lead box and check and control everything, pull out the radioisotope, the radio-labeled antibody from the vial into a syringe that contains the dose, the prescribed dose with the 50-milligram radioactive iodine, and then put that in a different lead box and send it up to the department So it's very simple. There are no tricky steps.
With the potential use within 72 hours.
And and so the only thing that major pharmacy at the Haas and still need to do.
And that is a requirement for the husband said they need to have a radiopharmacy, but any large hospital. The U.S. has that and definitely all the hospitals treating pediatric oncology.
So the only thing that.
The radiation pharmacy needs to do is to receive the radio labeled antibody ended then let bucks.
[noise] and check and control everything and.
Pull out the rate to isotope.
Resonate with antibody from the vial and syringe that contains the doses that prescribed dose with the 50 military radioactive I'd.
And then put that in a different let box and ended up at the Department and then they are ready to inject.
So.
It's very simple that's no tricky Steph so they don't need to do anything but check that what they are receiving is where they order it and make sure that the total amount they track up and the syringe is equivalent to 50 military afraid you isotope antibody and that's it.
If we look at the at at that you'll teach him it's going to be exactly the same we want to lever up ready to use.
Klaus Merlau: They don't need to do anything but check that what they are receiving is what they ordered and make sure that the total amount they drag up in the syringe is equivalent to 50 milligrams of radioisotope antibody. If we look at the lutetium, it's going to be exactly the same. We will deliver ready-to-use lutetium-labeled antibody, and the dose, typically the vial will contain maybe 80, 90 milliliters of radioactively-labeled antibody, and it will have a prescription saying that X microliters of this solution contains Y milliliters. And then the radiopharmacist responsible, if the lutetium is prescribed 50 milliliters, they will take that dose The lutetium is exactly the same.
Teach him labeled antibody and the dose and they typically they're viable contained maybe 80 90, maybe curry afraid to actually be labeled antibody and it will have a prescription saying that ex Michael lead US up. This solution contains Y Mediacore and then the major pharmacies responsible if the patients as well.
Slide 15 degree they will take that dose outlets. The violent the rest is Scott hi that radiopharmacy that Lou teach them as exactly the same they'll just have X amount of off the teach him labeled antibody in Dubai, but for us as a company. It takes about one and a half hour to radio label the antibody.
Klaus Merlau: They will just have the X amount of lutetium-labeled antibody in the vial. But for us as a company, it takes about one and a half hour to radiolabel the antibody and quality check it, and then we put it in. It takes 15 seconds. So it's a much easier radiolabeling process, and we don't need to double-check that it still has the necessary binding affinity because lutetium never affects the binding affinity of the antibody, at least until what we know today.
And quality check it and put it in a while packet and ship it off Wes when we raise to enable to teach them.
It takes 15 seconds.
So it's a much easier radio labeling process, and we don't need to double check that it still has the necessary binding affinity.
'cause it's into teach them never affects the binding affinity of the antibody at least until what we know today, but it's given good reasons because the challenge with the.
Klaus Merlau: But it's given good reasons because the challenge with umbiltumab iodine is that iodine is known for sometimes disrupting the binding side of the antibody because one of the tyrosines is sitting pretty close to the binding side. Now this gets technical. So to summarize shortly, it's a lot easier for us to radiolabel with lutetium, it's the most stable product, and therefore we can ship it out to tens of thousands of patients every year, whereas with iodination, it's...
With the button up I didn't he said the idea is known for sometimes Destructing di di finding side, if the antibody because one of the tyres seem to sitting pretty close to the opposite the binding side now it becomes technically so to summarize shortly it's a lot easier for us to raise was able to teach them. It's the most stable product and.
Therefore, we can ship it out to tens of thousands of patients every year west well I had a nation it's.
Definitely doable to send out a couple of thousand vials per year, and you could probably scale it up a bit more but it's just much easier it wouldn't see some constraint.
Klaus Merlau: It's definitely doable to send out a couple of thousand vials per year, and you could probably scale it up a bit more, but it's just much easier with the lutetium contract. The next question is from Etzer Darout, Guggenheim. Please go ahead, sir.
Hi, Thank you for that.
The next question is that's a drop Guggenheim. Please go ahead Sir.
Great. Thanks for taking the question just a couple from me. The first maybe if you could elaborate a little bit on the good fight and meeting with the FDA burden I Didnt get your positive takeaways from from from the from that interaction on with respect to sort of the refiling well, but the early and all the second question.
Etzer Darout: Great. Thanks for taking the question. Just a couple for me.
Klaus Merlau: The first, maybe you could elaborate a little bit on the type A meeting with the FDN about Mberta Mabin. I guess your positive takeaways from that interaction with respect to sort of the refiling of the DLA, and I have a second question. Sure.
Sure I mean, it's pretty clear that on the CMC, we have resolved all the issues that they have the quest and really ready to put that together in a resubmission package. That's still some issues we need additional clarification on in terms of.
Klaus Merlau: I mean, it's pretty clear that on the CMC, we have resolved all the issues that they have requested, and we are ready to put that together in a resubmission package. There are still some issues we need additional clarification on in terms of the level of response rates and the number of patients they want to see response rates from, and they and us are still discussing it. We are putting breathing packets together for them to be resubmitted next week. So, we are on the track, as we have said, to get everything put together. And I'm very confident that we will be able to do that. That was referring to the Taipei meeting. Your other question was: Yeah, so the other question was about the bispecific programs. I guess first with the GD2 bispecific, asking the obligatory question as to when we may be able to see sort of the initial data.
Level of response rates and number of patients they want to see response rates from and and and they they announced that still discussing it'd be a putting a briefing package together for them to be resubmitted next week. So so we are on the track as we have said two to get everything put together and I'm very confident that that'd be.
We'll be able to do that.
That was referring to the type B meeting your other question was.
Yeah. So the other question was on the on the bi specific programs I guess first with the GT to buy specifically asking the obligatory question as to when we may be able to see the initial data and then on the CD 33 T cell engager any any potential differentiation.
Klaus Merlau: And then on the CD33 T cell engager, any potential differentiation that you are seeing preclinically from other programs, and maybe some color there? I think it's too early for us to give any details on that. I think we have said that we are trying to see if we can present data at a company science day update that we hope to hold in December this year. Don't hold your breath for it, but look forward to the company update in December, where we can hopefully provide the first data sets from the Biospecific Antibody Study. Great. Thank you. We have a question from Alec Stranahan, from Bank of America. Please go ahead. Hey guys, thanks for the update and for taking our questions. Just two from me.
That few years seen pre clinically from from other programs and maybe some some color there.
I think it's too early for us to give any details on that I think we have said that we are trying to see if we can present data on that company science. They update that we hope to help hold in December this year. So so.
Don't hold your breasts, where it but look forward to that.
The company update in December well be hopefully can provide the first datasets from from the bi specific antibody study.
Great. Thank you.
Okay.
We have a question from Alex Stranahan Bank of America. Please go ahead.
Hey, guys. Thanks for the update and for taking our questions just two for me.
First with the studies from Britain on TTR getting underway on can you just help us frame, whether there are any unique differences and these expanded patient population.
Alec Warren Stranahan: First, with the studies for Umbertinab DTPA getting underway, can you just help us frame whether there are any unique differences in these expanded patient populations from Umbertinab 131 in the pediatric setting, in terms of, you know, limitations with delivery method or preference for individual tumor types in the adult study? And I guess along those lines, do you see the intracerebral ventricular administration maybe capping expansion into some of these larger patient populations? And secondly, for Nexamab and frontline neuroblastoma, how compelling for physicians and patients do you see removing the need for standard ASCT in this setting? And do you think this alone could be enough for clinical adoption? Thanks.
Number.
131 in the pediatric setting I'm in terms of you know limitations with delivery method or preference for individual tumor types in the adult study and I guess, along those lines do you see the interest rate growth and Tricolor administration, maybe capping expansion into some of these larger patient population and secondly for next to the Mab and front.
Line neuroblastoma, how compelling for physicians and patients you see removing the need for standard ASCII tea I'm in this setting and do.
Do you think this alone could be enough for clinical adoption. Thanks.
Yeah, I like let's start with the first question about them, but it might be today, then we can get back to a second one. So you would do you asking about the DCP and that's in the middle of the stole my eyes and also we put it early is that an indication where we already have seen some indications if if they can see in the ultra luxury three study where we try.
Klaus Merlau: Alec, let's start with the first question about Umbertinab DTPA. Then we can get back to your second one. So you were asking about DTPA, and as I said, medulloblastoma, as I also reported earlier, is an indication where we have already seen some indications of efficacy in the 03133 study where we have already treated 27 patients with medulloblastoma. And we're kind of looking at this as a very important setting.
You did already 27 patients with medulloblastoma and and we are kind of looking at this and say a very important setting and rather than using the new Oklahoma patients wherever you already achieving very great results. We wanted to see if there wasn't a possibility to further.
Klaus Merlau: And rather than using the neuroblastoma patients where we are already achieving very great results, we wanted to see if there was a possibility to further increase the doses and the efficacy of Umbertinab in a population where we are seeing clear signals of efficacy. And therefore, it was a nice and perfect fast-track pass for ombudsmap DTPA lutetium from a development perspective to go on We have clinical evidence from the iodinated form, and we have a group of patients with an unmet medical need, and we are staying true to our commitment to develop pediatric oncology compounds. So that makes a lot of sense and is also attracting quite a bit of interest from pediatric brain tumor consortiums in the U.S. to participate in that development. And yes, expanding this construct, the DTPA-conjugated onboard map, into the adult setting is clearly going to increase the number of patients. But will the umbilical catheter, or the interventricular catheter be a limiting factor? I don't think so. I think any neurosurgeon in both Europe and the U.S. is perfectly skilled at placing these catheters.
Increased the dosing and the fixed see off of a bottom up in a population, where we are seeing clear signals of efficacy.
And therefore, it was a nice and perfect fast track.
Cost for the on button up DT pay to teach them a tough from a development perspective to go on with the middle of US don't have we have clinical evidence.
From the IDE and they did for them and we have a group of patients with an unmet medical need and we are staying true to our commitment to develop pediatric oncology compounds.
So so that made a lot of sense and is also attracting quite a bit of interest from from he'd you actually.
Rachel Mcminn short just in the U.S. to participate in that development.
And yes, expanding with this constructive BGP a conjugated about them up into the adult setting is clearly going to increase the number of patients well they wouldn't be my acastis of the instruments circle that can be a limiting factor I don't think so I think any nursery.
You run in both Europe, and the U.S. is perfectly skills in placing these catheters and it's kind of like in my opinion, just a CNS autocad.
Klaus Merlau: And it's kind of like, in my opinion, just a CNS port-a-cat, and any surgeon can put in a port-a-cat, and any neurosurgeon can put in an umbilical catheter. So I don't foresee that being a limiting issue. And there are almost never any issues because the reservoir is placed under the skin, so you don't have infection risks from the outside.
And any surgeon can put in a pool to CAD and any newer surgeon can put in my I guess, Don So so I don't foresee that being a limiting issue and that's almost never any issues because they wrestle wireless placed under the skin. So you don't have infection risk somebody outside sales. So it seems as its a pretty safe and.
Klaus Merlau: So it seems as if it's a pretty safe and clear possible way forward for these constructs. That was the Unburdened Mouth question. Then you had a question about Nexidermab also? Right, yeah, the first line, ASCT, and whether this is sufficient for a clinical adoption or not, in your view. The first line.
Yeah possible way forward for these constructs.
That was the best of my questions. Then you had a question about mix. It I've also.
Right Yeah. The first fine if he and whether this is a sufficient for a clinical adoption in your view.
The first line.
I'm not sure I understand the question.
Klaus Merlau: I'm not sure I understand the question. Right, so first-line neuroblastoma, I guess, you know, how compelling would removing the need for standard ASCT be in this setting? Well, I think, well, my take on this is that if we can show that we have similar long-term, call it two-year, event-free survival with Naxodermab, and we can show that we have a significant reduction in hospitalization and the use of morphine when treating front-line or blastoma patients with an exetumab versus dinotoximab.
Right. So first line neuroblastoma, and I guess, how compelling would be reducing the need for standard at Cts study.
Oh I think about my.
Take on this is that if we can show that we have similar long term call. It two year eventually survival when next set him up.
And we can show that we have a significant reduction in hospitalization and they use of morphine when treating frontline older stoma patients when they sit 'em up versus trying to talk so Matt it's pretty well established what that days of hospitalization and they use of morphine is full.
Klaus Merlau: It's pretty well established what the days of hospitalization and the use of morphine are for patients in the front-line treated with dinotoximab. And if we can show that the number of hospitalization days goes from 35 to 40 days per five-cycle treatment goes down from that to less than three days, which we know we have less than one day on average with exetumab. And at the same time, the total use of morphine goes down from X. I mean, we have shown what I would consider a clear clinical benefit, even if there's no significant difference in the side effect profile. And I think you will see that the side effect profile, although we, of course, also see side effects, hypertension, and pain, with naxitamab, compared to the amount of side effects you see when giving dinatoxamab in frontline in combination with IL-2, which is the indication that they have, is significantly lower.
Patients in frontline treated with Diana talks about and if we can show that the number of hospitalization days goes from 35 to 40 days for a five cycle treatment goes down from that to less than three days, which we know you have less than one day on average with next set them up and that's it.
Same time, the total use of morphine goes down from X 2.25, X. I mean, we have shown I would what I would consider a clear clinical benefit if that's even if there's no significant difference and side effect profile and I think you will see that that the side effect profile. Although we of course also see.
Side effects hypertension, and pain with next set them up compared to the amount of side effects, you see when giving a diner tux him up in front line in combination with <unk>, two which is the indication that that that they have is significantly lower.
So I think that's what would it take to be compelling as I said significant reduction and use of morphine and hospitality station and serious adverse events and at the same time same level off to you and then free survival.
Klaus Merlau: So I think that's what it would take to be compelling, as I said, a significant reduction in the use of morphine and hospitalization and serious adverse events, and at the same time, the same level of two-year event-free survival. And two-year event-free survival is pretty well-established for without DD2 antibody 40% to 45% of two-year event-free survival with dinatoximab 60% to 65%. And the only data we have seen so far is Dr. Morris' two-year event-free survival of about 70%, and that was in his first 37 patients.
And to your then free survival is pretty well established for without you did two antibody, 40% to 45% a two year in free survival, but then it talks about 60% to 65% and the only data we have seen so far is to adopt them or us too you have entry somehow it up about 70%. So so.
It was on his first 37 patients.
And I consider that compelling.
Klaus Merlau: And I consider them compelling. Thank you. We have a question from Anupam Rama, from JP Morgan. Please go ahead, sir. Hi guys, thanks so much for taking the question and congratulations on all the progress. Just a quick clarification question on the GD2, GD3 vaccine. Sorry if I missed this in the opening comments, but the Phase 2 trial in neuroblastoma is supposed to start in the first quarter of next year, right? But what are the gaining factors to starting this study?
[laughter]. Thank you Brett.
I have a question from Onempower drama JP Morgan. Please go ahead Sir.
Hi, guys. Thanks, so much for taking the question and congrats on all the progress just a quick clarification question on the Gd to Judy three vaccine.
Sorry, if I missed it in your opening comments, but the phase two trial in neuroblastoma supposed to start is supposed to start in the first quarter of next year right, but what are the gating factors to starting the study. Thanks so much.
Anupam Rama: Thanks so much. Yeah, we are still looking at the combination with the beta-glycan that they have been using and discussing with MSK both the sourcing of the beta-glycan and the eventual need for that. But besides that, there are no major gauging factors, and we are also discussing with patient organizations about the first study we are looking at is to start a study in second CR. There is clearly an interest in participating in a front-line study from patient organizations with the vaccine where you randomize between the vaccine and placebo.
Yeah, we're still looking at the combination with repeated like hand that they have been using and discussing with M.S.K. boasts the sourcing of the beat it like NMD eventual need for that and that but besides that there are no major gating factors and we also discussing with patient.
Organization about a the first study we are looking at is to start the study and say can see there's clearly an interest of oh participating in a frontline study and from from patient organizations a.
With with the vaccine, where you randomized between vaccine or placebo.
But but besides all the other things that we also need to do I don't see any significant gating factors.
Klaus Merlau: But besides all the other things that we also need to do, I don't see any significant gating factors. Great. Thanks so much for taking our questions. The next question is from Peter Larson, Barclays. Please go ahead, sir. Hey, I like the pronunciation of my name.
Great. Thanks, so much for taking our question.
The next question is from Peter Larson is Barclays. Please go ahead Sir.
Hey, Bill.
Like the fashion, where they become more European.
Peter Lawson: I've become more European. So this is Peter Lawson from Barclays. And just on, I may have missed this; I apologize as well. So the initial data for the GD2 CD3 by specific, is that gonna be at your potential R&D day? And like, what could we see? Would that be patient responses at that point? As I said, I don't have any data that I've seen yet, but it's our plan to see how much we can drag out of the database and have it available for our scientific update in the future.
Buckley and just.
I may have missed this I apologize as well so the initial data for the GT to Cdthree by specific is is that.
Is that going to be out your potential R&D day in like what we see with that be patient responses to that point.
At the pit I don't have any data that I've seen yet, but it's our plan to see how much we can drag out of the database and have it available for how a update scientific update in December.
Okay, and then just on the the rain a criteria data from buttoned up.
Klaus Merlau: Okay, and then just on the renal criteria data from BertaMap that the FDA requested, would we see that as well at some point? I definitely plan to see if we can present it at the scientific update date also, if we cannot disclose it before. And that would be a scientific conference, not at your R&D day.
The idea of course, it would we see that as well at some point.
I definitely plan to see if we can presented at a scientific update also if we cannot disclose it before.
And that would be a scientific conference not at your R&D day.
No I think we'll try to because I know that there's such a big interest for what we have available.
Klaus Merlau: No, I think we will try, because I know that there is such a big interest in what we have available. So, we will probably try to see if we can communicate at least preliminary evaluations of that. But, as I said, I don't think it would be fair to wait.
So we would probably try to to see if we can communicate at least preliminary evaluations of that but but but as I said, it's it's a and I don't think it would be fair to wait. So so if we haven't said anything before I would definitely try to to see if we can present, what we have available at the that the scientific update day.
Klaus Merlau: So, if we haven't said anything before, I would definitely try to see if we can present what we have available at the Scientific Update Day. Thank you. And then how should we think about the cash runaway with just a series of launches and the potential monetization of vouchers? I'll let Bo answer that question.
Good. Thank you and then how should we think about the cash runway just with a series of launches and the potential minutes.
Monetization infectious.
Oh that bill answer that question [laughter], yeah. So.
Bo Kruse: Yeah, so... Frank, repeat, I didn't hear your question. I was just making some other notes on the financial runway. On the cash runway, just with the potential launches and then the monetization of the vouchers. How should we think about the runway?
Your friend repeat I didn't hear your question I was just making some of those on the financing one way.
Run up on the cash runway just with the potential launches and then the monetization of the vouchers how should we think.
Think about the runway so they basically.
Bo Kruse: So basically, the launches themselves, if they happen, would, of course, require some funding. In spite of that, we are good through the end of 2022, including only our current cash position and the net proceeds from the monetization of the two PFEs from Naxitimab and Ombertamab. So when we say that we're good through the end of 2022, that's excluding product revenues and any income from potential partnerships. Thank you so much. Thanks for taking the questions. We have a follow-on question from Robert Burns, H.C. Weinreich. Please go ahead, sir. Hey guys,
The launches himself if they happen would would of course require some funding on a rig.
Crisis that we are good through the end of 2020 true I'm doing only our current cash position and the net proceeds from the monetization of the tupi of east from them, but.
Actually them up in about a month.
And so when we say that we are good for the end of 222 is excluding or the product revenues are and any income from potential partnerships.
Thanks, So much this thing of course.
Well.
We have a follow on question Robert Burns HC, one hurt Wainwright. Please go ahead Sir.
Hey, guys. It's a one more question for me.
Robert John Burns: One more question for me. Given the advantages of also allowing for scintigraphy and subsequent dosimetry with the lutetium-labeled Invertimab, in addition to the manufacturing advantage that you guys would have with that asset, do you envisage potentially developing the lutetium-labeled Invertimab in a manner with which you could potentially replace 131 Invertimab in indications where 131 is going Well, I mean, it's a fair question.
Given the advantages of also allowing for some take or pay and subsequent dosimetry with dilutive label them burden lab. In addition to the manufacturing of energy, but you guys would have with with an asset you envisions potentially developing the tedium labeled the brunt of it in a manner with which you could potentially play.
131 important have any indications at 131 is going up.
Well I mean it.
It's a fair question I think in the end its appeal to start doing a new study Andy let some inkling metastasis from the office Docomo, even that you I think you probably already have more than 40 patients under study and we are starting a phase Twoa multicenter study in T I pity.
Klaus Merlau: I think in the end, it's uphill to start doing a new study in the leptomeningeal metastasis from the upper stoma or even DIPT, where we already have more than 40 patients in the study, and we are starting a phase two multi-center study in DIPT before year-end this year. So, I do not foresee that happening. I foresee that we will have primarily umbertumab DTPA lutetium for the adults, and we will keep it for the first indications because, as you know as well as I do, we are just starting phase one, two studies now with umbertumab DTPA. So, we are looking at something that could potentially come to the market. I mean, if we are really world record setters in developing new drugs, six, seven years from now, we could have the product on the market, and umbertumab, hopefully, will come to the market next year. So, I do not foresee planning to substitute umbertumab in the first indications that we are getting approval for with the iodinated version with anything for the next six to seven years. And if you know what you're doing six to seven years from now, let me know, because I don't know what I'm doing six to seven years from now.
Before year end this year, so so I I I do not foresee that I foresee that we will have a primarily the ability to pay to teach him for the adults and we will keep for the first indications because you know as well as I do we are just starting phase one two studies now with a button that TCPA.
So we're looking at something that potentially could come to the market I mean, if we have really world record set us in developing new drugs.
Six seven years from now we could have the product on the market and the bus about hope when it comes to the market next year. So I I do not foresee planning to substitute a a bottom up and the first indications are that we are getting approval for and would the iden native version with anything for the next six to seven years and.
If you know what you are doing six to seven years. So [laughter], let me know because I don't know what I'm doing six to seven [laughter] during the question and congrats again.
Operator: Okay, thanks again. There are no further questions at this time. I'd like to turn the conference back over to management for closing remarks. Look forward to continuing Y-mAbs and have a great weekend. Thank you. That concludes the call. This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.
Okay. Thanks again.
There are no further questions at this time I'd like to turn the conference back over to management for closing remarks.
Well, thank you everyone for dialing in and participating and.
Look forward to continuing why maps and have a great weekend. Thank you propose the call.
This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.