Q3 2021 Y-mAbs Therapeutics Inc Earnings Call
Good day and welcome to the wine Nabs therapeutic and Therapeutics, Inc. Third quarter 2021 earnings Conference call. Today's conference is being recorded let me quickly remind you that the following discussion contains certain statements that are considered forward looking statements as defined in the private Securities Litigation Reform Act of 1995.
Operator: and welcome to the YMab's Therapeutics end uproptuix end's third quarter 2021 earnings conference call. Today's conference is being recorded.
Operator: Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined in the Private Security 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, 2020, as filed with the SEC on March 1, 2021, and in the company's subsequently filed SEC reports. At this time, I would like to turn the conference over to Thomas Gadd, the company's Chairman and CEO.
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 31st 2020 as filed with the SEC.
See on March 1st 'twenty, 'twenty, one and in the Companys subsequently filed SEC reports at this time I would like to turn the conference over to Thomas Gad, The company's founder Chairman and President. Please go ahead Sir.
Thomas Gad: and Good morning everyone, and thank you for joining us today for our third quarter earnings call. During the quarter, we have made notable progress with Danielsa and Umberto Matt, as well as our bi-specific compounds created under the White Bicone platform and the starter platform, essentially constituting the three pillars of our system. We had a strong 2021 thus far, and the resubmission of the Ombudsma BLA is progress We held a type B meeting with the FD in September, during which we confirmed our path towards a pre-BLA meeting in January, potentially followed by a resubmission of that BLA.
Thank you Hillary.
Hey, good morning, everyone and thank you for joining us today for our third quarter earnings call.
During the quarter, we have made notable progress with Danielle.
That's.
As well as the five specific compounds traded on the Wi Fi axon platform and the Sada platform essentially constituting the three pillars of our business.
We had a strong 2021.
Farm and.
The Resubmission after your first BLA is progressing well.
Type B meeting with the FDA in September.
Which we confirmed our path towards a pre BLA meeting in January essentially followed by a resubmission.
Yeah.
Thomas Gad: Both Danielza revenues and the number of treatment centers have exceeded our internal expectation for the launch, so we're very pleased with the initial adoption of Daniela. Claus Miller will provide more details shortly. I'm also pleased to report that we made additional progress in China this quarter, together with Cyclone Pharmaceuticals, our strategic partner for mainland China, Hong Kong, and Macau. The BLA for Daniela for treatment of patients who relapse and refractory and high regional bifoma was accepted by the NMPA in China and subsequently granted priority review by the Center for Talk Evaluations.
Boston Joseph revenues, and the number of treatment centers and have exceeded our internal expectations for the launch.
We were very pleased with the initial adoption of the announcer.
Bill will provide more detail shortly.
I'm also pleased to report that we made additional progress in China. This quarter together with cyclone pharmaceuticals, our strategic partner for mainland China, Hong Kong and.
Yes.
The BLA for Danielle so for treatment of patients with relapsed refractory high risk neuroblastoma.
Except for the MTA in China, and South capacity granted priority review by the center for chalk evaluation.
Thomas Gad: In addition, it's notable that Daniela has been prescribed for the first time in China, and the first seven patients have received treatment in the Hanain Boa Medical Tourism Pilot Zone. Notably, a significant number of new patients are lined up, and further cycling plans to open up a second center in the Cheyin pilot song. The BIS-specific programs under the White Bycone platform continues to advance.
In addition, as notable but then you're also has been prescribed for the first time in China and the first seven patients have received treatment.
How nimble are met.
Medical tourists tourism pilot song.
Notably a significant number of new patients are lined up and so.
For those cyclone plans to open up a second center in that.
Hey, Jim pilots so.
The bispecific programs onto the wide by phone platform continue to slip out.
Thomas Gad: We are now dosing patients in our phase two small cell long cancer study with nevitravaal and a subcontaneous formulation. The I&D for our CD-33 bi-specific for pediatric AML has been submitted. And this promising treatment will potentially address an important pediatric disease. Our excitement over the starter technology remains strong, as we continue to optimize the platform that will potentially be able to deliver medicines to treat many cancers and move as it moves closer to the clinic.
We are now dosing patients in our phase II small cell lung cancer study wouldn't even talk about that.
Subcutaneous formulation.
And did you fall a CD 33 by specific for pediatric AML has been submitted.
And this promising treatment will potentially address an important pediatric unmet need.
Our excitement over the Sada technology remains strong.
We continue to optimize the platform that potentially will be able to deliver medicines to treat many kansas.
And move in and move closer to China, we are on track to file the first R&D.
Thomas Gad: We are on track to file the first I&D, Follow GD2 shot on him in the fourth quarter. Next year, we are planning to file at least one more N&D for the Shata Construct. We ended the third quarter with $215 million in cash.
G D to start in the fourth quarter.
Next year, we are planning to file at least one more R&D, but the sada construct.
We ended the third quarter with $215 million in cash. So we believe we have a strong balance sheet to not only support the continued commercialization of Danielle the potential launch of embarks them up but we also.
Thomas Gad: So we believe we have a strong balance sheet to not only support the continued commercial cessation of Danielsa and the potential launch of Umbertaamap, but we are also Advancing the Luciam conjugated on birth map PTPA and Nevitrothurama into late stage development. At the same time, we continue to advance construct develop under our Wi-Fi Club and SADA technology platforms, and we are actively working with both our platforms when it We are very pleased with our current financial position, which Beau Kuzz, our chief financial officer, will elaborate on during this call. And with that, I'm very pleased to turn it over to Klaus.
Advancing the.
Conjugated Birdsmouth D T P. A I've never choose them out into late stage development at the same time, we continue to advance construct develop on Wi Fi.
And Sada technology platforms, and we are actively working with both of our platforms when business development.
We're very pleased with our current financial position, which spoke who's our chief Financial Officer will elaborate on later on.
On this call.
And with that I'm very pleased to turn it over to Klaus. Thank you.
Klaus: Thank you. Thank you, Thomas, and welcome to YMF Ceputic's third quarter 2021 earnings calls. We are very pleased that you have chosen to join us today. Let me start out with an acetylama or Danielsa.
Thank you Thomas and welcome to Wyman offset periodic third quarter 'twenty 'twenty. One earnings calls we are very pleased that you have chosen to join US today, Let me start out with our next set of math or Danielle. So Daniels is approved for the treatment of patients with relapsed or refractory high risk neuroblastoma in the bone or bone marrow.
Klaus: Danielza is approved for the treatment of patients with relapsed or refractory, high-risk no opostoma in the bone or bone marrow who have demonstrated a partial response, or minor response for stable disease to prior therapy, and was approved by the FDA under the accelerated approval pathway. We recorded Daniels-Rae. and net sales of 9 million in the third quarter, which reflects a strong 10% shipment growth over the last quarter, offset by an impact of certain rebates reflecting a shift from both the treatment center mix and the patient mix from independent, inpatient to outpatient. We are particularly encouraged by the increase in the number of treatment centers that have gained experience with Danny Elsa. At the end of the quarter, we had delivered to 24 centers across the country.
Who have demonstrated a partial response minor response or stable disease to prior therapy and was approved by the FDA on the accent about right at approval pathway.
We recorded then he also net sales of $9 million in the third quarter, which reflects a strong 10% buyouts shipment gross well last quarter offset by an impact of certain rebates, reflecting a shift from both the treatment center makes and the patient makes from independent from inpatient to outpatient we are.
Larry encouraged by the increase in the number of centers treatment centers that have gained experience with any of that at the end of the quarter. We had delivered a 224 centers across the nation.
Klaus: We continue to be very pleased with the Danielsa launch, while revenues look promising and the number of treatment sites are ramping up nicely. It is also notable that we have seen a more than 40% increase in the number of vials delivered in the U.S. outside MSK compared to the second quarter. In other words, a significant increase in business across the country. The overall number of vials shipped in the U.S. increased, as mentioned, by approximately 10% in the third quarter versus the second quarter. And our gross revenue reflected that one-to-one.
We continue to be very pleased with Danielle So was it any other launch while revenues look promising and the number of treatment sites are ramping up nicely. It is also notable that we have seen a more than 40% increase in the number of vials delivered in the U S. Outside M S. Kate comparison too sick.
Quarter in other words, the significant increase in the business across the country. The old number of vials shipped in the U S increased as mentioned was approximately 10% in the third quarter versus second quarter and our gross revenue reflected that want to what we did however, see a shift towards more patients being treated.
Klaus: We did, however, see a shift towards more patients being treated on an outpatient basis, some of whom started as inpatient treatments in their first cycles but then thereby becoming a subject to available rebates as outpatients from the public health system or PHS. This shift, together with a significantly increased share of vials being sold outside MSK, has had an impact on the gross-to-net calculation, and this has had an impact on the reported growth in net revenues for the third quarter.
On an outpatient basis, some of which started as inpatient treatments in their first cycle, but then, thereby becoming subject to available rebates as outpatients from the public health system. All P. H S. This ships together with a significantly increased share of vials being sold outside M. S. K.
He has had an impact on the gross to net calculation and this impacted reported gross and net revenues for the third quarter going forward I believe the increase in the gross to net calculation related to the P. A L.
Klaus: Going forward, I believe the increase in the gross-to-net calculation related to the PSS eligible hospitals will subside, but the mixed shift in favor of non-MSK institutions is expected to continue into 2022, as more and more centers outside MSK learn about and start prescribing Daniela. We are very pleased to see Daniela get substantial traction in the market at this point. It is also notable that we are now seeing commercial uses of Danielsa in early access programs in China, Maina, and Latam.
Electrical hospitals, Wilkes upside, but the mix shift in favor of the name is K institutions is expected to continue into 2020, two as more and more centers outside M. S. K learn about and start prescribing Daniels that.
They're very pleased to see then yes that get substantial traction in the market at this point. It is also notable that we are now seeing commercial uses of Danielle. So in early access programs in China, Mina and let them royalty income is obviously still very modest, but we have high hopes for future growth.
Klaus: Royalty income is obviously still very modest, but we have high hopes for future growth and are putting significant effort into expansion into additional international markets. We recently held a key opinion leader webinar that included a detailed review of data from Danielsa in first line, as well as HITS data.
And are putting significant effort into expansion into additional international markets.
We recently held a key opinion leader that'd be now that included a detailed review of data from <unk> in first line as well as hits data hits refers to chemo immunotherapy for resistant high risk neuroblastoma with any Elsa is given in a combination treatment often referred to as hits consisting of.
Klaus: HITS refers to chemoimmunosherapy for resistant high-risk normalblestoma, where Danielsa is given in a combination treatment often referred to as HITS consisting of Danielsa, actually humanized necetanth, thereby the AIDS, erinotekin, thamesolamide, and sacramastem. Key opinion leaders, as well as other medical doctors in the field, appreciate the solid data that formed the basis for the FDA approval and the convenience of being able to offer an outpatient treatment, which brings new degrees of freedom to the table as opposed to watching the patient nonstop in the ICU day in and day out.
Then he ulcer.
Actually humanized mixing them up and thereby the H Irina chicken, Tim It's all the mines and soccer Marston the key opinion leaders as well as other medical doctors in the field I appreciate the solid data that formed the basis for the FDA approval and the convenience of being able to offer an outpatient treatment, which brings new degrees of free.
To the table as opposed to watching the patient nonstop in the ICU day in and day out I'm very pleased with our commercial and medical Affairs organization, who has done an outstanding job of educating physicians and nurses about the any elsa and guiding the many new treatment centers true their very first experience with any other during the quarter.
Klaus: I'm very pleased with our commercial and medical affairs organization, which has done an outstanding job of educating physicians and nurses about Danielsa and guiding the many new treatment centers through their very first experience with Danielza during the quarter. Our ongoing clinical trials for Danielsa in Barcelona, Spain, and MSK in New York, for first-line neuropostoma maintenance treatment, as well as chemo-combination trials for refractorneurn We are still in the process of initiating an international phase two multi-center frontline trial, and our multi-center chemo combination trial will start screening patients next week. We also have a phase two osteosocomar trial ongoing. Now turning to unburthamap for the treatment of pediatric patients with CNS leptominegal metastasus from noopostoma.
Our ongoing clinical trials with any outside in Barcelona, Spain and M. S. K in New York for first line neuroblastoma maintenance treatment as well as chemo combination trials for refractory neuroblastoma patients are progressing nicely. We are still in the process of initiating an international phase two multi center frontline trial and our move.
Just send a chemo combination trial will start screening patients from next week. We also have a phase II osteosarcoma trial ongoing.
Now turning to onboard them up for the treatment of pediatric patients with CNS Leptomeningeal metastasis from the Opus stone that based on feedback from the FDA at a type B meeting in September where we provided the FDA with additional detailed data and statistical analysis plan. We have recently requested a pre BLA.
Klaus: Based on feedback from the FDA at a tight B meeting in September, where we provided the FDA with additional detailed data and a statistical analysis plan, we have recently requested a pre-BLA meeting. Pending a positive pre-PLA meeting in January, we aim to initiate a resubmission of the unburtumab BLA shortly after the meeting. And we believe we are persistent.
Pending a positive pre BLA meeting in January we aim to initiate a resubmission of the on both of them up BLA. Shortly after the meeting and we believe we are positioned to complete the submission during the course of the first quarter 2022.
Klaus: to complete the submission during the course of the first quarter 2022, potentially allowing for FDA approval of onberdumab in the fourth quarter 2022. Needless to say, we are very pleased to be aligned with the FDA on next steps and believe that, if approved, umbertoamab will be a significant benefit to patients with CNS leptomynegal metastasis from nooplastoma, who are The European marketing application for Emburtomapp was prepared in parallel with the USBLA and was submitted to EMA in April of this year.
Potentially allowing for FDA approval of a bottom up in the fourth quarter of 2022 Needless to say we are very pleased to be aligned with the FDA on next steps and believe that if approved on both of them up will be a significant benefit to patients with CNS Leptomeningeal metastasis from neuroblastoma, who are currently facing a major unmet need.
Neat.
The European marketing application for one third on that bus prepare out in parallel with the U S. BLA and was submitted to EMA in April of this year preliminary feedback from EMA was received back in September and we are in the process of responding to questions raised by that agency. We believe the evaluation of our application is progressing as planned.
Klaus: Preliminary feedback from EMA was received back in September, and we are in the process of responding to questions raised by that agency. We believe the evaluation of our application is progressing as planned. Furthermore, our interim phase 1 dose escalation data for Humberto map for diffuse intrinsic pontine, bioma, or DIPG has paved the way for our multistender phase 2 study, known as study 102 for which we have filed an I&D recently. We expect to administer up to three repeated doses of amperdomo in that study.
Furthermore, our interim phase one dose escalation data from both of them up for diffuse intrinsic pontine glioma or D. I P. T has paved the way for our multi center phase two study known as study one O two for which we have filed an I N D. Recently.
We expect to administer up to treat repeated doses them put them up in that study.
Now turning to the lutetium labeled about them up or I N D. Four 177.
Klaus: Now turning to the lutecium-labelled oberto-map, our I&D for 177-Lutisium-Omburtom-D-PA for the treatment of medullopostoma, which is the most common type of primary brain cancer in children, is now open, and the first patient has been treated. This Muti-Center Phase 1-2 trial is based on our clinical experience with treating medulloplastoma patients with iodine 131 on-Bertamab, and we are obviously excited to see 177-Lotot-D-TPA make its way into the clinic to establish the safety profile and determine the maximum tolerated dose.
Teach them on bottom up did you pay for the treatment of tomato look I still am up which is the most common type of primary brain cancer. In children is now open in the first patient had been treated.
This multi center phase one two trial is based on our clinical experience from treating Madhu Lucasfilm patients without even once you really want them both of them up and we are obviously excited to see 177 to teach them mumbo Jumbo D. G. P. A make its way into the clinic to establish the safety profile and determine the maximum tolerated dose.
Klaus: The FDA has granted us rare pediatric disease designation for the lutecium labeled Bertramov antibody program for the treatment of medullobostoma, which makes us eligible for a priority review voucher upon potential approval of the BLA for this rare pediatric cancer. Among our leading compounds under development, four now have rare phyticic disease designation, and this designation for 177-Lutisian on Bertimuthia DTPA DT In addition, we have opened a basket trial in B7H3-positive CNS leptomynecancas in adults.
F D. A has granted us rare pediatric disease designation for the lutetium labeled on both of them up antibody program for the treatment of tomato lupus Domo, which makes us eligible for a priority review voucher.
Upon potential approval of the BLA for this rare pediatric cancer.
Among our leading compounds under development fall have now rapid disease designation and this designation from 177, new teaching them put them up D. G. P. A further increases our chances of ultimately receiving multiple povs.
In addition, we have opened a basket trial NP seven H Street positive CNS slipped some unequal Kansas and at US well, we hope to leverage our prior experience from treating adults would be seven H <unk> positive brain metastasis, with Iot and 131 or both of them up.
Klaus: Well, we hope to leverage our prior experience treating adults with B7H3 positive brain metastasis with iodine 131 on Bertomar. The study has started screening patients, and we hope to see the first adult patients treated with 177 Lutetian-en-Urton-R-P-T-P-A in late November. We are thrilled to widen our clinical reach to include adult indications for the Lutthesem-177-Mberton adult also. Our white bi-clone constructs are a new generation of T-cell engaging bispecific antibodies that may potentially destroy tumor cells by recruiting HOS T cells. The Bightlone format contains two binding arms for the tumor target and two binding arms for the T cells. The Bightloan format was designed to have the minimal binding affinity necessary to recruit T cells.
The study has started screening patients and we hope to see the first adult patients treated with 177 to teach them on both from a P to P. A in late November we are thrilled to widen our technical reach to include adult indications for their nutrition bunch 77 of Boe to metal.
So.
Oh, well why buy to own stocks.
A new generation of T cell engaging bispecific antibodies that may potentially destroy tumor cells by recruiting of recruitment of Haas T cells. The bite loan formats contains two finding arms for the tumor target and two binding arms for the T cells.
So what's.
It was designed to have minimal binding affinity necessary to recruit T cells. We've expanded never tried to maps clinical trial to reach to include small cell lung cancer patients in our phase II study with the subcutaneous administration and the study is now recruiting patients. We also plan to expand the ongoing study.
Klaus: We have expanded the Nivetrotomats clinical trial to include small cell lung cancer patients in our phase two study with subcutaneous administration, and the study is now recruiting patients. We also plan to expand the ongoing study of nevatrotomab at MSK into two separate phase two arms, one in ooplastoma and one in osteosarcoma. We have submitted an IND for our next in line bi-specific antibody, the CD33 CD-C3 bispecific generated on the YBiclone platform, and we have already experienced significant interest from multiple clinical sites to participate in the study.
And you often have a trust them up at M. S. K into two separate phase two arms wanted to know if a stoma and one osteosarcoma and we have to.
<unk> submitted an int for our next in line by specific antibody. The Cds 30, Tracey to treat by specific generated on Wi bites on platform and we have already experienced significant interest from multiple clinical sites to participate in the study we hope to open the study for pediatric AML patients within the next three to six 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 a handful of sada talking for clinical development and as previously announced the first Sada R&D is expected to be against you did too and planned for filing in December this year.
Klaus: We hope to open the study for pediatric AML patients within the next three to six 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 a handful of SADA targets for clinical development, and as previously announced, the first SADA idea is expected to be against D2 and planned for filing in December this year. We are seeing significant partnership interest for the SADA technology, and we are positioned to leverage the SADA platform in the coming months. We believe the SADA technology has already shown great potential and that it can potentially improve the efficacy of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radio-labeled agents.
We are seeing significant partnership interest for the Sada technology, and we are positioned to leverage the sada platform in the coming months. We believe the Sada technology has already shown great potential and that it can potentially improve the efficacy of radio naval shipyard in tumors that have not historically demonstrated meaningful responses to radio labeled agents.
We are truly excited about this platform.
Thus, let me finish off with some more general comments, we believe we are well positioned to grow why maps as a commercial stage company with any outside already being shipped to multiple treatment centers across the country and significant international progress being made but then he also franchise is progressing even better than we had hoped for.
Klaus: We are truly excited about this platform. Thus, let me finish off with some more general comments. We believe we are well positioned to grow WiMAPs as a commercial state company. With Danielsa already being shipped to multiple treatment centers across the country, and significant international progress being made, the Danielsia franchise is progressing even better than we had hoped for. For Burma, the resubmission of the BLA is inside, and the pre-BLA meeting has been requested. At the same time, we are widening and deepening our pipeline by advancing our antibody constructs through the clinic, predominantly the SADA constructs, the BISP specifics, and the next generation of Umbudamab, ratio-labeled antibodies.
For the Resubmission of the BLA is inside and the pre BLA meeting has been requested at the same time, we are widening and deepening our pipeline by advancing our antibody constructs true the Sydney predominantly the sada constructs the bi specifics and then next generation onboard them up.
Actual labeled antibodies in other words, we remain fishy and they're very excited to move forward to build a commercial business that helps patients and further elevate our continued development.
Now, let me invite Bo to share his remarks on this quarter's financial things.
Thank you Klaus.
We reported the Neilson net revenue of $9 million for the quarter ended September 32021, there were no revenues reported in the quarter ended September 32020.
Klaus: In other words, we remain busy, and they 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 performance. Thank you, Klaus.
So let's take a closer look at the opening and operating expenses for the third quarter of 'twenty or 'twenty. One we note that research and development expenses increased by $2 1 million from 21 million for the quarter ended September 32020 to $23 1 million for the quarter ended September 32002.
Bo: We reported Daniels and net revenue of $9 million for the quarter ending September 30th, 2021. There were no revenues reported in the quarter ending September 30th, 2020. As we take a closer look at the operating expenses for the third quarter of 2021, we note that research and development expenses increased by 2.1 million from 21 million for the quarter ending September 30th, 2020, to 23.1 million for the quarter ending September 30th, 2021.
The new one.
This is this increase was primarily attributable to a $1 9 million dollar increase in clinical trial expenses and $1 8 million in Greece in employee related costs, including salary benefits and noncash stock based compensation for personnel related to our expanding workforce. These increases.
Were partially offset by a $1 4 million increase or decrease in outsourced manufacturing costs.
Selling general and administrative expenses increased by $2 4 million from $11 6 million for the quarter ended September 32020 to 14 million for the quarter ended September 32.
Bo: This increase was primarily due to a $1.9 million increase in clinical trial expenses and $1.8 million in employee-related costs, including salary, benefits, and non-cash, stock-based compensation for personnel related to our expanding workforce. These increases were partially offset by a $1.4 million increase or decrease in outsourced manufacturing companies. Selling, general, and administrative expenses increased by $2.4 million from $11.6 million for the quarter ending December 30th, 2020, to $14 million for the quarter ending September 30th, 2021.
2021.
The increase in selling general and administrative expenses, primarily reflect a $2 1 million increase in employee related costs, including salary benefits and noncash stock based compensation for personnel related to the launch and commercialization of the Nielsen.
We reported a net loss for the quarter ended September 32021 of $28 9 million. This corresponds to six to six <unk> per share basic and diluted compared to a net loss of 32.8 million or 82 cents per share basic and diluted for the quarter ended September 30th 2020 with <unk>.
Bo: The increase in selling, general, and administrative expenses primarily reflect a $2.1 million increase in employee-related costs, including salary, benefits, and non-cash stock-based compensation for personnel related to the launch and commercialization of Daniels. We reported a net loss for the quarter ended September 30th, 2021, of 28.9 million. This corresponds to 66 cents per share, basic and diluted, compared to the net loss of 32.8 million, or 82 cents per share, basic and diluted for the quarter ending September 30th, 2020. The decrease in net losses was primarily driven by the Daniels of Red Lerner.
Kris and net loss was primarily driven by the than he is a revenue stream.
We ended the third quarter with a cash position of $215 7 million compared to $114 6 million at year end 2020. The increase reflects proceeds from the sale of our 10 years approach review voucher in January 2021, where we needed 62.
So sharing 40% of the net proceeds from the sale with M. S. K as part of our license agreement.
Our September 30 cash balance also reflects a $107 7 million total net proceeds raised in a public offering in February 2021, partially offset by the net cash used in operational activities of $68 7 million for the nine months ended September.
Bo: We ended the third quarter with a cash position of 215 million compared to 114.6 million at year-end 2020. The increase reflects proceeds from the sale of our Daniels Priority Review Voucher in January 2021, where we netted 62... million after sharing 40% of the net proceeds from the sale with MSK as a per hour license agreement. Our September 30th cash balance also reflect $107.7 million net proceeds raised in our public offering in February 2021.
So it is 2021.
We continue to believe Ryan labs remains in a healthy financial position now this concludes the financial update.
Now I'll turn the cold over to Thomas.
Okay. Thank you very much for.
This marks the end of today's prepared remarks and at this time.
Sorry, you can't hear me.
Hello.
Hello.
All right I can hear you fine.
You bet, Yeah, sorry Fang.
Okay. Thank you Bo this remarks, you end up today.
Ox.
Bo: Partially offset by the net cash used in operational activities of $68.7 million for the nine months ending September 30th, 2021. We continue to believe RIMAPs remains in a healthy financial position. Now, this concludes the financial update, and I'll now turn the call over to Thomas. Okay, thank you very much, Paul. This marks the end of today's prepared remarks, and at this time, I would like to...
Hello can you hear us.
I think so.
You need to mute nope.
Yeah.
Well I can hear you operator.
Open up the call for Q&A, our clouds in bulk and you hear us.
Okay. Thank you very much. This marks the end up todays prepared remarks at this time I would like to open the call up for questions. Let's open the line now and perhaps I can ask the operator to remind you that the procedures with the prestigious office submitting your questions. Thanks.
Thomas Gad: Operator.
Operator: Are you there? Yes, Thomas, we can do you fine. Okay, thank you, Bob. That's the end of today's prepared remarks.
Okay. At this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the.
Operator: Bo, can you hear us?
Operator: I think. Bo, do you need to mute? Nope.
Operator: Well, I can hear you operators. So we're going to open up the call for Q&A. Klaus and Bo, can you hear us?
Thomas Gad: Okay, thank you very much, Bo. This marks the end of today's prepared remarks. At this time, I would like to open the call up for questions. Let's open the line now, and perhaps I can ask the operator to remind you of the procedures for submitting your questions. Thanks.
Starkey.
One moment, please I'll be poll for question.
Our first question is from Alex Stranahan of Bank of America. Please proceed with your question.
Hey, guys. Thanks for taking our questions. So two for me both just trying to get a temperature on the Daniels launch them. So I guess could you could you speak to the timing of when patients starting therapy in <unk> or was it fairly evenly spread or was it more weighted to either the beginning or at the end I mean is it possible.
Operator: Okay, at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing start. One moment, please while we poll for questions. Our first question is from Alex Straanahan of Bank of America. Please feed us your questions. Hey guys, thanks for taking our questions. So, two from me.
That that we'll see many of those patients carrying over into for Q as well and I guess of the patients that started therapy in <unk> and <unk> and how.
How many completed therapy at this point and were there any I guess the discontinuation from treatment.
Yeah.
Okay.
Operator.
Okay Bowling class can you hear us.
Thomas can you hear me.
Yeah, we're going to try to redial and there's a there's a problem with the lines.
Alec Warren Stranahan: Hey guys, thanks for taking our questions. So, two from me, both just trying to get a temperature on the Daniels launch. So I guess could you speak to the timing of when patients started therapy in 3Q? Was it fairly evenly spread, or was it more weighted to either the beginning or the end? And is it possible that we'll see many of those patients carrying over into 4Q as well? And I guess of the patients that started therapy in 1Q and 2Q, how many completed therapy? at this point, and were there any, I guess, discontinuations from treatment?
Ladies and gentlemen, please standby, while we handle it well, let me deal with the technical difficulty.
Apologize.
Okay.
Yeah.
Okay.
Okay.
It's happened before.
Got it.
Okay, ladies and gentlemen, we are back one moment library open the question Kevin.
Yes.
Uh huh.
Okay.
All right. Our first question from Alex Stranahan of Bank of America.
Yeah.
Hey, guys can you hear me.
Operator: Okay, Bo and Klaus, can you hear us? Thomas, can you hear me?
Yeah absolutely.
Operator: We're going to try to redial in. There's a problem with the lines. Okay, ladies and gentlemen, please stand by while we handle it while we deal with a technical difficulty. All done.
Perfect perfect. So just trying to get a attempts from the Daniels the launch I guess could you just speak to sort of the timing of when patients start therapy in <unk> or was it fairly evenly spread.
Operator: Okay, ladies and gentlemen, please stand by while we deal with a technical difficulty. Thank you. Okay. Hey, ladies and gentlemen, we are back. One moment while I reopen the question to you. Okay. All right, our first question was from Alex Tranahan, with Bank of America.
Across the quarter or was it more sort of weighted in the beginning or the end and you know I guess of the patients that started therapy in an <unk> or I guess, mostly to queue. How many have completed therapy at this point and were there any discontinuation and then I have a follow up.
Alec Warren Stranahan: Hey guys, can you hear me? Yeah, absolutely. Perfect, perfect. So just trying to get a temperature on the Daniels launch, could you just speak to sort of the timing of when patients started therapy in 3Q? Was it fairly evenly spread across the quarter? Or was it more sort of weighted in the beginning or the end?
Well I mean.
Alec Warren Stranahan: And, you know, of the patients that started therapy in one queue or, I guess, mostly 2Q, how many have completed therapy at this point? And were there any discontinuations? And then I have a follow-up question.
Obviously, new sites outside they must came in you have to first patient they try out is not.
Primary or secondary refractory patients, but typically patients that have received.
Klaus: Well, I mean, obviously, new sites outside MSK, many of the first patients they try out are not primary or secondary refractory patients, but typically patients that have received chemotherapy in combination with dynotoxymyp and are still not coming into remission. And many of these patients do not complete more than two or three cycles of Danielsa. But as we see more and more sites, retreating, or so.
Chemotherapy in combination with that and talk to them up and these paid and they're still not coming into remission and many of these patients do not compete more than two or three cycles of Danielle, so, but but as we see more and more sites retreating or treating new patients. We also see these sites.
Klaus: treating new patients. We also see these sites starting to treat patients that are actually true primary, secondary, and refractory patients. But as I said also, what we can see is that these patients, after the first cycle, where they often do it as inpatient treatment, when they realize that patients are actually capable of moving out of the hospital the same day they receive the treatment a few hours later, then they start converting to outpatient treatment.
Starting to treat patients that are actually two primary or secondary refractory patients, but but as I said also what we can see you said that these patients after the first cycle, where they often do it is as it is.
Inpatient.
Treatment when they realize the patients actually.
Capable of moving out.
The hospital the same day they received the treatment a few hours later, then they start converting to outpatient but.
Additional details on the distribution of type of pace, but I think it's it's a bit too early to start giving out.
Klaus: Additional details on the distribution of the type of patients, I think it's a bit too early to start giving out. Okay, okay, but would you say that, I guess, most of the patients were sort of spread across the quarter in terms of treatment, or was there maybe like a bullet towards the end of the quarter? That could oh, it was pretty. I would say it was pretty even despite being pretty throughout the quarter, yeah, no, it's uh, Okay, and then my second question, you know, next year. July, as the summer months, was maybe a little bit more silent than August, that could also be reflecting others.
Okay, Okay, but would you say that.
I guess most of the patients were sort of spread across the quarter in terms of treatment or was this maybe like bullets towards towards the end of the quarter.
That could quickly.
I would say that's pretty evenly spread.
Dakota, Yeah, no. It's it's.
Okay.
Okay and then my second question.
July is the summer July August summer months was maybe a little bit more silent than Oh.
By September but that's it.
It can also be reflecting all those things.
Okay. That's helpful. And then I guess looking to next year, how big a role do you see the EU and China, playing into expanding the market for Danielle.
Klaus: Okay, that's helpful. And then, looking to next year, how big a role do you see the EU and China playing in expanding the market for Danielza? And I guess do you have any comments around your approach to the launch in those geographies? Well, the EU is probably going to be just... early access programs for next year. China, we have quite good expectations for all; we see a very significant interest in China.
Do you have any comments around your approach to the launch in those geographies.
Well, you, it's probably going to be just.
Hum.
Our early access programs for.
So next year, China, we have.
Quite good expectations for all we see a very significant interest in China and as we previously have said, we expect based on the regulatory feedback we have received that we could get the Chinese approval.
Klaus: And as we previously have said, based on the regulatory feedback that we have received, we could get Chinese approval late in the first quarter or during the beginning of the second quarter next year in China, which means that in the second quarter, we could come to the Chinese market with any other and start expanding it. And as Thomas mentioned, we are already treating commercial patients in China. in some of these research areas, whether it's allowed to treat them with products that are approved in the EU or the U.S. So we have quite big expectations. There are a lot of patients that are available for treatment out there and need treatment.
Late first quarter or during the beginning of second quarter next year in China, which means that in second quarter, we could come to the Chinese market with with any outside.
And started expanding it and as Thomas mentioned, we are already treating commercial patients in China and in some.
Some of these research areas, whether it's allowed to treat with.
Products that are approved in EU or the U S.
So we have quite a big expectation so that's a lot of patients that.
Available for treatment out there a need to treat them.
Yeah.
Thank you.
Our next question is from Joseph.
Joseph Thome: Our next question is from Joseph Thome of Cowan. Please proceed with your question.
Of Cowen. Please proceed with your question.
Joseph Thome: Hi there, good morning, and thank you for taking our questions. Maybe just the first one.
Hi, there good morning, and thank you for taking my questions. Maybe just the first one in terms of bringing new centers online.
Klaus: In terms of bringing some news Centers online, can you just kind of walk us through what's necessary? Do you have to work through, like, a formal P&T committee to get approval before bringing a new center online, and is that easing at all? And then maybe the second point, on the side of technology, you indicated seeing significant partner interests. If you could just kind of qualify what you mean there, is this a geographic partner, is this a combo partner, or would you be looking to license sort of individual assets? Sure.
Can you just.
Kind of walk us through what's necessary do you have to work through like a formal PMT committee to get approval.
Before a new a new center line and is that easing at all and then maybe the second point on the on the Sada technology, you indicated seeing significant partner interest. If you could just kind of qualify what your what you'd been there it's a geographic partner.
Combo partner or would you be looking to license sort of individual.
Thanks.
Sure.
Klaus: So, I think the challenges we are seeing in activating new sites for Danielle's are primarily getting the education of the staff and making sure that they can make the staff available for the actual treatment. Because it's such a quick infusion, it does take more than one person to be close to the patient, and you need somebody to manage the pain side of it also, but in particular, make sure that the staff is trained in handling the side effects. The pharmacy buying procedures and the reimbursement setups, et cetera, are normally not giving rise to any major hassles or problems. We have not experienced any at the site where we have actually sent the product.
So.
I think that the challenges we are seeing on an activating new sites with Daniels is primarily getting education of the staff and making sure that they can make the stats available for the actual treatment.
Because it's because it's such a quick infusion.
It it does take more than one person to be close to the patient and they need somebody to manage the pain side of it also.
And but in particular, making sure that the staff is trained on handling decided things.
The the.
Pharmacy buying procedures and the reimbursement set ups et cetera, it's normally not giving any major hassles of problems that we have not.
Spirits any in the sites, where we have actually sent the product too. So so I think it's it's primarily getting the education and I think the MSL team is doing a great job there.
Klaus: So I think it's primarily getting the education. I think the MSL team is doing a great job there. On the SADA BD side, what we can see now is that, and what we are looking for, SADA is a tech platform. It's basically like when I was with GenMab and we had the fully humanized antibody technology, that there's no limit to how many Sata constructs you can make. There is no limit to how many different antibodies you can make.
On the Sada BD side, what we can see now is that and and what we are looking for you know sada as a tech platform. It's basically like when I was with Genmab and we have to fully humanized antibody technology that it's there's no limit to how many sada constructs you can make it as there's no limit.
How many different antibodies you can make.
Klaus: So if a company outside WMAPs has a target where they believe that their antibody against this target would be fantastic to have a way to conjugate against, but they are concerned about the traditional problems with these, which is that you have these circulating antibodies for such a long time. The startup would solve that problem, and we could license the rights to use that particular target and antibody with our startup technology to that company, and we could do another platform, deal with another company that has different targets.
So so.
A company outside Wimax has a target where they believe that.
That the antibody against this target would be fantastic to have the right to conjugate against.
But are concerned about the traditional problems with east, which is that you have the circulating antibody for such a long time, the sada would solve that problem and we could license.
The rights of use that particular talking an antibody for with all the Sada technology to that company and we could do it other platform.
With another company that has different targets, so and unnecessary comment so that that's basically no limits to how many different companies. We can make partnerships with for as long as there's topics that have nothing you can say taken and technically that's no problem. So it's two different partners once to make each of their own.
Klaus: and a certain company. So there's basically no limits to how many different companies we can make partnerships with for as long as there are targets that have not been, you can say, taken. And technically, there's no problem. So if two different partners want to make each of their own CD20 or CD-30 or CD-39, whatever you can think of as potential targets for a SADA construct, then they can do them. And that's why I'm saying that we can do the most: multiple partnerships where the partners get the right to develop their SADA constructs for the entire world. So it's not regional for that, to that extent.
CD 20 E O C. D 39, whatever you can think of that as potential targets for a sada construct than they can do with them and that's why I'm, saying that if we can do multiple partnerships, where the partner get the rights.
True.
Develop their sada construct for the entire world. So it's not regional cause that to that extent and of course, our own sada constructs, including the first one will be a filing D. I N D. A.
Operator: And of course, our own Sata constructs, including the first one where we are filing the I&D for the DB2 SADA here in December, potentially could be available for partnering also. I think one of our partners or those that we are talking to would be interested in that. So there are multiple possibilities for partnerships for this Arbetsac platform. Perfect. That is very helpful. Thank you very much.
For the two sada here in December potentially that could be available for partnering also.
One of our partners, although we are talking to would be interested in that so.
There's multiple possibilities for partnerships for the Sada platform.
Perfect that is very helpful. Thank you very much.
Yeah.
Thanks Joseph.
As a reminder, if you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue for participants using speaker equipment may be necessary to pick up your handset before pressing attacking you.
Tessa Thomas Romero: As a reminder, if you would like to ask a question, please press Star 1 on your telephone keypad. The confirmation tone will indicate your line is in the question queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the Star keys. Our next question is from Tessa Romero of J.P. Morgan. Please proceed with your question.
Our next question is from Tessa Romero with Jpmorgan. Please proceed with your question.
Tessa Thomas Romero: Hey guys, good morning. Thanks so much for taking our questions. So my first question is about Danielleza.
Hey, guys. Good morning. Thanks, so much for taking our question. So my first question is about Daniels, our he talked about the X X M. S volume increase but could you just clarify what portion of sales actually came.
Klaus: You talked about the XMSK volume increase, but could you just clarify what portion of sales actually came outside of MSK? And how many sites have been activated at this point? I think you've talked in the past about a 40 percent target for the year. I guess how are you tracking towards that target? And I have a follow-up as well. Yeah, okay. First,
Outside of MF, K and how many sites have been activated at this point I think you've talked in the past about a 40 target for the year.
How are you tracking towards that target.
And I have a follow up.
Klaus: Yeah, okay, first, I said we had 24 sites by the end of..., by the end of the quarter that received Deny Elsa. And during the quarter, more than 40% of sales were now outside MSK. Is that, was that what you asked?
That's a lot.
Yeah, Okay. So first I.
I said, we had 24 sites by the end of.
By the end of the quarter that has received Daniels.
And.
And during the quarter more than 40% of sales is now outside M. S. K.
Yeah.
Does that was that what you asked.
Tessa Thomas Romero: Yeah, so I guess as we're thinking about sort of 4-Q here, Klaus, you know, what are you thinking about what target site number you might be able to hit by the end of this year? Do you think it may take a little bit longer than originally anticipated to hit that 40 target?
Yeah, So I guess as we're thinking about as we're thinking about Florida before I came here class.
Now how are you thinking about what target site number you might be able to hit by the end of this year do you think it may take a little bit longer than originally anticipated to hit that 40 target.
I think it's it's a little early to say whether it be I mean, maybe 40 sites is on the high end, but but we are making a good effort too.
Klaus: I think it's a little early to say whether we, I mean, maybe 40 sites is on the high end, but we are making a good effort every day to reach out to doctors, meet them at conferences, but when we get to 40 sites, it seems like it's a stretch since we have had eight new sites on average if you divide the three quarters up to 24. But let's see where we end up.
This insights every day to reach out to doctors to meet them at conferences, and then but but will we get to 40 sites.
It it seems like its a stretch since we on average have had eight new sites. If you divide the three quarters up to up to the 24, but but let's let's see where we end up I think the important thing is that we continue to see an interest in in learning about Daniels and trying it out on patients and I think as I said we are early.
Klaus: I think the important thing is that we continue to see an interest in learning about Danielsa and trying it out on patients. And I think, as I said, we are early into the launch, with the launch starting in February this year. So we are looking at the first eight months right now, and let's see what happens in the... rest of the year.
The launch with the launch starting in February this year. So we are looking at the first eight months right now and let's see what happens there.
And the rest of the year I'm still very positive on what we have seen and I think.
Klaus: I'm still very positive about what we have seen, and I think we had not anticipated to see the level of sales that we have actually reached this year. So it's, I'm positive, and I still think that this makes a huge difference for a lot of patients. But, of course, it takes time to penetrate a market where the existing product has been on the market for four to five years, and that has been in a number of technical studies at some of the leading sites. So that's, of course, making it, you can say, a lot of hard work for our team to get in and have doctors having practical experience with the product.
We had not anticipated to to see the level of sales that we have actually weights this year. So.
So it's I'm positive and I still think that that this makes a huge difference for a lot of patients.
But of course, it takes time to penetrate into a market where by the existing product has been on the market for four to five years and that has been in a number of clinical studies had at some of the leading sites. So that's of course, making it.
You can see a lot of hard work for our team to get in and have the doctors, having practical experience with the product.
Yeah.
Tessa Thomas Romero: Yeah, that's helpful. And then, if I could squeeze just a quick follow-up on the frontline MSK phase two study, what is the latest on when we could see those results presented? I think you've talked about potentially presenting them at December R&D Day, so just was wondering what the latest thought was there.
That's that's helpful. And then if I could squeeze just a quick follow up.
On the frontline and ask all of phase.
<unk> two study what is the latest on when we could see those results presented I think you've talked about.
Italy presenting them at December R&D day, So I just was wondering what the latest thoughts flagstar.
Yeah, I don't think we have said anything new.
Klaus: Yeah, I don't think we have said anything new. I still haven't seen the data, but as I said, the patient, the last patient came into the study in February, so it's data collection. So we're still hoping to have data available and give an update at Auntie Day in December. Okay, great.
I still haven't seen the data, but as I said the patient the last patient came into the study.
So so its data collection so so.
So hoping to have data available and give an update.
At the R&D day in December.
Okay great.
Tessa Thomas Romero: Okay, great. Thanks so much for taking our questions.
Thanks, so much for taking our questions.
Thank you.
Yeah.
There are no more questions. At this time you have reached the end of the question and answer session. I will now turn the call over to Thomas Gad for closing remarks.
Operator: There are no more questions at this time. We have reached the question and answer session, and I will now turn the call over to Thomas Gad for closing remarks.
Alright, well, thank you everyone for participating in today's call.
Thomas Gad: All right, thank you everyone for participating in today's call, and have a great weekend. Thank you. Bye-bye. This concludes today's conference. You may disconnect your lines at this time. Thank you.
Great weekend. Thank you bye bye.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and have a great day.
Operator: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.
Okay.
Mhm.
Operator: Thank you.
Yeah.
Yeah.
Operator: I don't know.
Mhm.
Uh huh.
Mhm.
Okay.