Q4 2021 Y-mAbs Therapeutics Inc Earnings Call
Operator: Good day, and welcome to the Y-mAbs Therapeutics, Inc. Earnings Conference call for the fiscal fall year of 2021. This conference is being recorded. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined in the Private Security 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.
Good day and welcome to the mine why mobs therapeutics.
Earnings Conference call for the fiscal full year of FY 'twenty one.
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 actual results may differ materially from those expressed or implied by these forward looking statements.
Operator: 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, 2021, as filed with the SEC on February 24th, 2022. At this time, I would like to turn the conference over to Thomas Gad, the company's founder, Chairman, and President.
A variety of factors.
Those risk factors discussed in the company's annual report on Form 10-K for the fiscal year ended December 31st 2021 as filed with SEC on February 24th 2022.
At this time I would like to turn the conference over to Thomas Gad.
<unk> founder.
Chairman and President. Please go ahead.
Thomas Gad: Please go ahead. Thank you, Joe. And thank you, everyone, good morning. And thank you for joining us for our Unique Call today. During the year, we made significant progress on executing our strategy and expanded on all the three pillars of our business. First, I'll lead Monarchal Antibodies, Danielle Chan, on Bertram F. Second, our bi-specific compound is under the white bike loan platform, and finally, the promising target is... Radio Pharma Shooter goes throughout a technology platform.
Thank you Joe and thank you everyone and good morning.
And thank you for joining us for our earnings call today.
During the year, we made significant progress on executing our strategy and expanding on all of the three pillars of our business.
First of all leading monoclonal antibodies Danielle side on thoughts about.
Second our bi specific compounds under the white box on platform and finally promising targeted.
Radiopharmaceutical Sada technology platform.
Thomas Gad: It's been almost exactly a year since we launched Danielsa, the much-needed treatment for children with relapsed refractory high-risk novoselma. We delivered not only an innovative treatment but also demonstrated our commitment to develop better and safer products addressing the medical needs of these children. We're encouraged by the benefits of Danielle, and we are squarely focused on expediting Danielle's adoption and continuing its development in expanded indications. And in parallel, we are leveraging our other platforms. Generate the Ground Bragging Date.
It's been almost exactly a year since we launched stand yeltsin the much needed treatment for children with relapsed refractory high risk neuroblastoma.
We deliver not only on the innovative treatment, but also demonstrated our commitment to develop better and safer products addressing the medical needs of these children.
We are encouraged by the benefits of Danielle it's out and we are squarely focused on.
On expedite anything else as adoption continues its development and expanded indications and in parallel we are leveraging our other platforms, who generate groundbreaking data.
Thomas Gad: After we launched Danielsa in the U.S. in February 2021, we've seen a nice ramp-up of sales, and we ended the year recording net revenue of $9.6 million.
After we launched on the outside the U S. In February 2020 one we've.
We've seen a nice ramp up of sales and we ended the year recording net revenue up $9 6 million in the.
Thomas Gad: In the fourth quarter, corresponding to a 7.1% increase over the third quarter and total product revenues of $32.9 million for the full year. The resubmission of Onbergimab BLA is progressing as planned. We held a pre-BLA meeting with the FDA in January, which confirmed our path towards a VLA resubmission in March. Summary of our two-by-storsedic program.
Fourth quarter corresponding to a seven 1% increase over the third quarter and total product revenues of $32 9 billion for the full year.
The resubmission of comparison might be like is progressing as planned we held a pre BLA meeting with the FDA in January .
Which confirmed our path towards a BLA resubmission in March.
Summarizing on our two bispecific programs.
Thomas Gad: We are continuing to dose patients in our small cell lung cancer study, and the IND file CD33 by specific for pediatric AML has been submitted. And we believe that this promising treatment can potentially address an important pediatric unmet medical need. With SADA, we are entering into a new frontier of radiotherapy, with the ability to precisely target multiple tumors. Our excitement over SADA technology grows as we work to optimize that platform, which we believe will be able to deliver medicines to treat many cancers. During the fourth quarter, we filed the IND for our first conflict, the GD2-SATA for GD2-positive solid tumors.
Continuing to dose patients in small cell lung cancer study and D. I N E C D 33 by specific well.
Pediatric AML has been submitted and we believe that this promising treatment can potentially address unimportant pediatric unmet medical need.
It sounds like we are entering into a new frontier radio therapy with the ability to precisely target multiple tumors.
Oh Sada technology grows as we work to optimize that platform that we believe will be able to deliver medicines to treat many cancers.
During the fourth quarter, we filed the IND for our first concept the Judy to Sada for JD to positive solid tumors.
Thomas Gad: And I'm looking forward to treating the first patients this summer. We are scheduled to file at least one more R&D application for a new SATA construct later this year. And we plan to file at least one IND per year moving forward. We ended the year with $181.6 million in cash, so we believe we have a strong balance sheet to support both the continued commercialization of Danielsa and the potential launch of Ombudsman, as well as the advancement of our early stage programs, such as the new constructs developed under the SADA technology plan.
And I'm looking forward to treating the first patient this summer.
We are scheduled to file at least one more on diesel a new shot a construct later this year.
And we plan to file at least one R&D program moving forward.
We ended the year with $181 6 million in cash. So we believe we have a strong balance sheet to support both the continued commercialization of Daniela.
And the potential launch of home births about.
As well as the advancement of our early stage programs such as the new construct developed under the Sada technology platform.
Thomas Gad: We're also actively working with our startup platform in business development. We are very pleased with our current financial position, which Bo Kruse, our Chief Financial Officer, will elaborate on later in this call. I entered into a loan agreement in 2019, at which point I pledged shares as a collateral. My pledge of shares was disclosed in our Spectre's Files in February 2021. So, over a year ago.
We are also actively working with all startup that phone with and business development.
We are very pleased with our current financial position, which folks who's our chief Financial Officer will elaborate on later on this call.
I answered into a loan agreement in 2019 at which point I pledged shares as a collateral.
My pledge of chefs, what's disclosed in our prospectus filed in February 2021, so about a year ago.
Thomas Gad: At that time, our insider trading policy allowed for such transactions to occur after approval by our general company. Institute of Heiress Market Facts. Including the biotic industry falling out of investors' favors in 2021, our stock price has declined from a high of approximately $55 to where it sits today. [inaudible] The decline in our stock price triggered four sales by my bank in January and February 2022 to repay that law. The loan has now been repaid in full, and no additional sales under this pledging agreement are coming.
At that time, our insider trading policy allowed for such transactions to a core after approval by our general counsel.
Due to the various market factors, including the biotech industry falling out of investors favors in 2020 one our stock price has declined from a high of approximately $55 to where it sits today.
The decline in our stock price triggered for sales by my Bank in January and February 2022 to repay that loan.
The loan has now been repaid in full.
Thomas Gad: In addition, I've terminated my current 10B5 plan, and Bo Kruse has done the same. In addition, our board has updated our insider trading policy, and the new policy prohibits the pledging of company shares as collateral in the future and also adopts some of the proposed SEC amendments to Rule 10b-5.
And no additional sales under this pledging agreement are coming in addition, I've terminated my current N P. Five plan and Bo Kruse has done the same.
In addition, our board has updated our insider trading policy.
And the new policy prohibits prohibits the patching of company shares as collateral in the future and also adopt some of their proposed as you see them that much to rule <unk> five.
Thomas Gad: This new policy will be posted on our website. In summary, we are very proud of the progress we made in 2021, and we are very optimistic and excited about Danielta's sales increasing, the unburden of BLA being on track, and the first SARTA IMD now being submitted.
This new policy will be posted to our website.
In summary.
We are very proud of the progress we made in 2020 , one and we are very optimistic and excited about the Nielsen sales, increasing embarrassment BLA being on track.
And the first sort of I N D now submit it and ongoing preclinical testing for additional cytokines.
I would also like to take the opportunity to acknowledge the effort of our ambitious team.
Which we recently expanded by hiring a new chief commercial officer Sue Smith.
Sue brings extensive commercial experience, including <unk>.
Several recent successful product launches within cancer and rare disease.
We are pleased to have her joining our leadership team and are already benefiting from her prior experience as we continue to optimize.
Our commercial franchise in order to leverage potential future products turbine from our core platforms.
Klaus Murlow: And ongoing preclinical testing for additional SARTA. I would also like to take the opportunity to acknowledge the effort of our ambitious team, which we recently expanded by hiring our new Chief Commercial Officer, Sue Smith. Sue brings extensive commercial experience, including several recent successful product launches within cancer and rare disease. We are pleased to have her joining our leadership team and are already benefiting from her prior experience as we continue to optimize our commercial franchise in order to leverage potential future products driven from our core platform. And with that, I'm very pleased to turn over the call to Dr. Klaus Murlow, Chief Executive Officer. Robert Klaus, thank you.
And with that I'm very pleased to turn over the call to Dr. Klaus Miller, Chief Executive Officer, Bill that Klaus Thank you.
Klaus Murlow: Thank you very much, Thomas, and welcome to Y-mAb Therapeutics' fourth quarter and full year 2021 earnings call. We're very pleased that you have chosen to spend this morning with us. During the year, we continue to optimize the value of our pipeline, and our progress includes having launched Danielsa and reported increased sales for our four consecutive quarters, while at the same time making progress in the resubmission of the Embertum at BLA. And we're also continuing significant investments in the potential game-changing SADA program.
Thank you very much Thomas and we'll come to the Wimax therapeutics fourth quarter and full year of 2021 earnings call. They're very pleased that you have chosen to spent this morning with us during the year, we continued to optimize the value of our pipeline and our progress included having launched Danielle sudden reported increased sales falloff praful.
Second to cordis, while at the same time, making progress in the Resubmission nuts and bolts might be late and we are also continuing significant investments into potential game changing sada programs now.
Klaus Murlow: Now turning to an excedema about Danyelza that is approved for treatment of patients with relapsed refractory high-risk nobustoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy and was approved by the FDA under the accelerated approval pathway. We recorded Danielsa net sales of $9.6 million in the fourth quarter, which reflects a strong 7% increase from the previous quarter.
Now turning to our next sit in my opinion that is approved for treatment of patients with relapsed refractory high risk neuroblastoma in the bone or bone marrow, who have demonstrated that partial response, my response or stable disease to prior therapy and was approved by the FDA under the accelerated approval pathway.
Danielle So let's say, that's a $9 6 million in the fourth quarter, which reflects the strong 7% increase from previous quarter and also encouraged by the increase in number of treatment centers that have gained experience with Danielle. So we have now delivered Danielle to 228 centers across the nation. We continue to be very pleased with the Daniels.
Klaus Murlow: We're also encouraged by the increase in the number of treatment centers that have gained experience with Danielsa. We have now delivered Danielsa to 28 centers across the nation. We continue to be very pleased with the Danielsa launch and the traction we are getting in the market at this point. The increase corresponds to four new centers since the last quarter, and approximately 40% of the vials sold in the U.S. are currently sold outside Memorial Sloan-Kettering.
The launch and the traction we're getting in the market at this point the increase corresponds to four new centers since the last quarter and approximately 40% of the vials sold in the U S are currently sold outside I'm Austin I'm kidding.
Klaus Murlow: It is also notable that we are now seeing commercial uses of Danielsa in early access programs in China, MENA, and LATAM. Royalty income is still modest, but given the incident rates in these regions... We have high hopes for future growth and are putting significant effort into expansion into additional international markets with our partners.
It is also notable.
We are now seeing commercial users of Danielle set in early access programs in China, Mina and let them go.
Royalty income is still modest but given the incident rates in these regions.
We have high hopes for future growth and are putting significant effort into expansion into additional international markets with all our partners.
Klaus Murlow: And I'm very pleased with our commercial and medical affairs organization, which did an outstanding job of educating physicians and nurses about Danielsa and guiding many new treatment centers through their first experience with Danielsa. At our R&D day in December, Dr. Mora from Barcelona Children's Hospital presented compassionate use data from an investigational infusion protocol of maxitumab, where he systematically increased the infusion rate during the treatment. By starting dosing at a very, very low infusion rate and gradually increasing the rate, Dr. Mora was able to exhaust nerve fiber signaling within approximately 60 minutes, thereby allowing for a substantial increase in the infusion rate during the remaining infusion.
And I'm very pleased with our commercial and medical Affairs organization, which has done an outstanding job of educating physicians and nurses about then he also and guided the many new treatment centers through that first experience with Daniels and.
D day in December Dr. Mora from Barcelona Children's Hospital presented compassionate use data from an investigational infusion protocol the kitimat well he's systematically increase the infusion rate during the treatment by starting dosing at very very low infusion rate and gradually increasing the rate of the moral of us able to.
It's Austin nerve fiber signaling without within approximately 60 minutes, thereby allowing for a substantial increase of the infusion rate during the remaining infusion using this new revised infusion scheme for which a provisional patent application has been filed by Y map stop Tomorrow and Memorial Sloan Kettering. It was observed that the total.
Klaus Murlow: Using this new revised infusion scheme, for which a provisional patent application has been filed by Y-mAbs, Dr. Mora, and Mora from Kettering, it was observed that the protocol may help reduce grade 3 and grade 4 adverse events. We believe this new insight can help us refine the maxitumab dosing regimen and thereby improve not only the safety profile and therefore the duration of therapy but also further reduce the frequency of do We consider this to be a strong competitive advantage over other approved DD2 therapies and believe this could open the door to exploring a number of DD2 positive indications in the adult field also.
Paul May help reducing grade three and grade for adverse events. We believe this new inside can help us refine the next set them up dosing regimen, and thereby improve not only the safety profile and therefore, the duration of therapy, but also further reduced the frequency of dosing we consider this to be a strong competitive advantage or the.
Approved TD to therapies and believe this could open the door to exploring a number of TD to positive indications in the battlefield also and we are in the process process of planning clinical trial for a number of such indications.
Klaus Murlow: And we are in the process of planning clinical trials for a number of such indications. To summarize, we are very optimistic about the long-term opportunity for Danyelsa, as judged by clinicians' feedback. Our focus remains on continued accelerated adoption, and looking ahead, we plan additional medical education training to broaden side activations. Sue Smith, our new Chief Commercial Officer, will execute a marketing strategy aimed at increasing market awareness, utilization, and duration of therapy of Danielse across the country. We expect Y-mAbs, under Sue's commercial leadership, to become a leader in the pediatric oncology field. Onbertumab is what we are turning to now for the treatment of pediatric patients with CNS leptomeningo-metastasis for noble stoma.
To summarize we are very optimistic about the long term opportunity, but any okay. That's understood.
By clinicians feedback.
Our focus remains on continued accelerated adoption and looking ahead, we plan additional medical educational training to broaden side activities Activations.
Sue Smith, our new Chief commercial officer will execute a marketing strategy aimed at increasing market awareness utilization and duration of therapy of <unk> across the country.
We expect why maps on the huge commercial leadership she has to be a leader in the pediatric oncology field.
Bottom up we had starting to now for the treatment of pediatric patients with CNS left them in England metastasis, when almost all man.
Klaus Murlow: We had a pre-BLA meeting with the FDA on January 13, 2022, and we are working closely with the FDA on the resubmission of the Onbertumab BLA. The agency had some final questions regarding access to the audit of historical data from the German database, which we use as a control group, and we have been working with the doctors in the market responsible for the database to provide verification on this matter. We are working diligently to meet all requirements from the FDA and expect to resubmit the entire Onbertumab BLA by the end of next month's first quarter in 2022.
A pre BLA meeting with the FDA on January 13th 2022 and we are working closely with the FDA on the Resubmission buds My BLA. The agency had some final questions regarding access to the audit of historical data from the German database, which we use as a control group and we have been working with the doctors for market respond.
For the database to provide clarification on this matter we are working diligently to meet all requirements from the FDA and expect to resubmit the entire in Baltimore BLA.
Klaus Murlow: Needless to say, we are very pleased to be aligned with the FDA on the next step and believe that, if approved, Onbertumab will be a significant benefit to patients with CNS leptomeningo-metastasis from noble stoma who are currently facing a major medical need. If approved, it will also be a welcome addition to our commercial franchise as the second BLA approval in as many years and will leverage our investment in our commercial organization in the U.S.
By the end of next month first quarter 2022 needless to say we are very pleased to be aligned with the FDA on the next steps and believe that if approved will be a significant benefit to patients with CNS, let someone they go metastasis from Morgan Stanley .
We're currently facing a major unmet medical need is approved it will be it will also be a welcome addition to our commercial franchise.
Second BLA approval in as many years and will leverage our investment in our commercial organizations in the U S.
Klaus Murlow: The European marketing application for Bodomab was prepared in parallel with the US BLA and was submitted to EMA in April 2021. Preliminary feedback from EMA has been received, and we are in the process of responding to questions raised by that agency. The evaluation of our applications is progressing as planned.
The European marketing application for them, but my best prepared in parallel with the U S. BLA and was submitted to EMA in April 2021 preliminary feedback from EMA has been received and behind the process of responding to questions raised by that agency.
Klaus Murlow: In addition, Interim Phase 1, dose escalation data on Bertamab, Partifuse, Intrinsic, Pontine, DiRoma, or DIPT, has paved the way for our Phase 2 study note as Study 102, for which we filed an IND in October. We are excited and hope to initiate this multi-center study in DIPT later this year. We expect to administer up to three repeated doses of Bertamab in that study. Turning to the SARTA technology, as you know, we are very, very excited about the prospects for this technology, and we are making good progress preparing additional IMDs and identifying additional SARTA targets for clinical development.
Evaluation of all applications is progressing as planned.
In addition, interim phase one dose escalation data follow on but I'm, not particularly intrinsic pontine glioma or D. IPG has paved the way for our phase two study known as study one O two for which we filed 90 in October you excited and hope to initiate that's this multi center study and D. IPG later this year, we expect.
To administer to treat repeat offenses and brought them up in that study.
Turning to the Sada technology.
No. We are very very excited about the prospects for this technology and we are making good progress preparing additional ind's and identifying additional salad toppings for clinical development. As a reminder, the sada technology platform allows for targeted delivery of radio isotopes and could potentially improve the efficiency and also the choose to purchase.
Klaus Murlow: As a reminder, the SARTA technology platform allows for targeted delivery of radioisotopes and could potentially improve the efficacy and also reduce the toxicity of radio-labeled therapeutics. Additionally, given the versatility of the SATA platform, we believe that SATA technology can be adapted for multiple tumor targets.
City of radio labeled therapeutics. Additionally.
Additionally, given the versatile versatility of the startup platform. We believe the Sada technology can be adapted for multiple tumor targets. We filed our first data in D. D. D. Chew Sada for treatment of TD to positive solid tumors last December .
Klaus Murlow: We filed our first SATA R&D application, the DD2 SATA, for treatment of DD2-positive solid tumors last December. We are also seeing significant partnership interest for the SATA technology, and we are well positioned to leverage the SATA platform in the coming months. We are truly excited about the potential of the SATA technology, which has already shown great promise, and we believe that it can further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents.
We are also seeing significant partnership interest for the Sada technology, and we are well positioned to leverage the sada platform in the coming months. We are truly excited about the potential of the Sada technology, which has already shown great promise and we believe that it can further unlock the potential.
Rachel Agency I predict in tumors that have not historically demonstrated meaningful responses to radio labeled agents.
Klaus Murlow: Thus, in general, we believe that we are well-positioned to continue to grow Y-mAbs as a commercial states company. With Danielta already being shipped to multiple treatment centers across the country and significant international progress being made, the Danielta franchise continues on a growth trajectory that we believe is just beginning. We are anticipating a DLA resubmission of OmbertaMap soon, and we are leveraging our Danielta experience to assure a successful launch of OmbertaMap, if approved.
Thus in general we believe that we are well positioned to continue to grow why maps as a commercial stage company, but then he also already being shipped to move multiple treatment centers across the country and significant international progress being made but then he also franchise continues on a growth trajectory that we believe is just beginning.
We are anticipating a D L. A resubmission of a bottom up soon and we are leveraging our G&A Danielle <unk>.
Experience to assure a successful launch of them put them up if approved at the same time, we are expanding our pipeline by advancing our constructs through the clinic predominantly the sada construct so why do we believe the best is yet to come the fiscal year 'twenty 'twenty. One has certainly been a significant year for US we are excited to move forward and unlock long term.
Klaus Murlow: At the same time, we are expanding our pipeline by advancing our constructs through the clinic, predominantly the SADA constructs, while we believe the best is yet to come. The fiscal year 2021 has certainly been a significant year for us.
Klaus Murlow: We are excited to move forward and unlock long-term shareholder value by continuing to build a commercial business that helps patients and further elevates our continued development across each of our platforms. Now, let me invite our chief financial officer Bo Krusev to share his remarks on the financials. Thank you, Klaus. We reported Danielsa Net Product Revenue of $32.9 million for the first year of sales.
Shareholder value by continuing to build a commercial business that helps patients and further elevate our continued development across each of our platforms now.
Bo Kruse: In addition, we reported licensed revenues of $2 million for the year ended December 31st, 2021, related to our licensing agreement with Adiom in Latin America. This compares to $20.8 million for the year ended December 31st, 2020, related to our licensing agreements in China with Cyclone and in Israel with Takeda. We did not have product revenues in 2020, but we also did not receive FDA approval until late November 2020. As we take a closer look at the operating expenses for the full year of 2021, we know that R&D expenses decreased by half a million from 93.7 million for the end of December 31st, 2020, to 93.2 million for the year ended December 31st, 2021.
Now, let me invite our chief Financial Officer, Bill cruises to share his remarks on the financials.
Yeah.
Thank you Klaus.
And he also net product revenue of 32.9 billion for the first year of sales. In addition, we reported license revenues of $2 million for the year ended December 31, 2000, and 2021 related to our licensing agreement with ADM in Latin America.
Which compares to 28 million for the year ended December 31st 2020 related to our licensing agreements in China with cyclone and in Israel with Takeda, We did not have product revenues in 2020, that's done deals that did not receive FDA approval until late November 2020.
As we take a closer look at the operating expenses for the full year of 'twenty 'twenty. One we note that R&D expenses decreased by half a million from $93 7 million for the year ended December 31st 2020 to $93 2 million for the year ended December 31st 2000 and so.
When you won the deal.
Bo Kruse: The decrease was primarily attributable to a $4.8 million increase in regulatory affairs expenses associated with costs incurred for the BLA submissions, Fornax System App, and Humberto Map in 2020, and a $13.3 million decrease in milestones and license acquisition costs related to our acquisition of the SATA technology from MSK back in 2020. These decreases were partly offset by increases in outsourced manufacturing costs of $6.2 million, clinical trial costs of $3.9 million, consulting services of $1.2 million, expenses for premises of $1.4 million, and employee-related costs of $4.1 million, including salaries, benefits, and non-cash stock-based compensation for personnel related to our expanding work.
Decrease was primarily attributable to a $4 8 million increase in regulatory.
Regulatory affair expenses associated with costs incurred for the BLA submissions for next season up antibody in 'twenty, 'twenty and $13 3 million dollar decrease in milestones and license acquisition costs related to our acquisition of decided technology from an Ms. Kate back in 2020.
These decreases were partially offset by increases in outsourced manufacturing costs of $6 2 million clinical trial costs of $3 9 million consulting services of $1 2 million expenses for premises of one 4 million in employee related cost of $4 1 million, including salaries benefits and.
Noncash stock based compensation for personnel related to our expanding workforce.
Bo Kruse: Selling, general, and administrative expenses increased by $9.8 million from $44.8 million for the year ended December 31, 2020, to $54.6 million for the year ended December 31, 2021. The increase in SG&A expenses primarily reflects an $8.9 million increase in employee-related costs, including salary, benefits, and non-cash stock-based compensation, primarily for additional personnel related to the launch and commercialization of Daniela. We reported a net loss for the full year ended December 31st, 2021 of $55.3 million, or $1.28 per share, basic and diluted, compared to a net loss of $119.3 million, or $2.97 per share, basic and diluted, for the year ended December 31st, 2020.
Yeah.
Selling general and administrative expenses increased by $9 8 million from $44 8 million for the year ended December 31st 2020 to $54 6 million for the year ended December 31st 2021, the increase in SG&A expenses, primarily reflects $8 $9 million.
Greece in employee related costs, including salaries benefits and non cash stock based compensation, primarily for additional personnel related to the launch and commercialization of stimulus.
We reported a net loss for the full year ended December 31st 2021 to $55 3 million or one to eight.
Dollar share basic and diluted compared to a net loss of $119 3 million or $2 97.
Per share basic and diluted for the year ended December 31st 2020. The decrease in net loss was primarily driven by the Daniels our revenue stream and the net proceeds from monetizing the priority review voucher. The P. F E associated with the FDA approval of the Nielsen.
Bo Kruse: The decrease in net loss was primarily driven by the Danielsa revenue stream and the net proceeds from monetizing the priority review voucher, the PAV, associated with the FDA approval of Danielsa. We ended 2021 with a cash position of $181.6 million compared to $114.6 million at year-end 2020. The increase of $67 million reflects proceeds from the sales of our Danielsa Priority Review voucher in January 2021, where we netted $62 million after sharing 40% of the net proceeds from the sale with MSK as per our license agreement.
We ended 2021 with a cash position of 181 6 million compared to $114 6 million at year end 'twenty 'twenty.
The increase of $6 million to $7 million reflects proceeds from the sales of our Daniels approaching review aren't you in January 2021, where we added $62 million after sharing 40% of the net proceeds from the sale within Ms. K, that's part of a license agreement.
Bo Kruse: Our December 31st, 2021 cash balance also reflects the $107.7 million net proceeds raised in our public offering back in February 2021. Although partially offset by the net cash used in operating activities of $102.6 million for the full year ended December 31st, 2021, we continue to believe that WIMAC remains in a very healthy financial position.
Our December 31st 2021 cash balance also reflects the 107 7 million net.
Net proceeds raised in our public offering back in February 2021.
Australia offset by the net cash used in operating activities of 102 6 million for the full year ended December .
31st 2021.
We continue to believe that wind that remains in a very healthy financial position.
Thomas Gad: This concludes the financial update, and I'll now turn the call over to Tom. Okay, thank you very much, but this mosque concludes today's prepared remarks. At this time, we can turn over the call to the operator to start Q&A. Thank you. Thank you.
This concludes the financial update and then I'll turn the call over to Thomas.
Okay. Thank you very much Paul this marks the end of today's prepared remarks.
At this time, we can turn over the call to the operator to start Q&A.
Thank you.
Yeah.
Operator: We will now begin a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the queue. You may press star 2 if you would like to remove your question from the queue.
Thank you.
Ladies and gentlemen, we will now be conducting a question and answer session. If you will.
To ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the queue.
You May press Star two if you really like to remove your question from the queue.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Alec Stranahan with Bank of America. Please proceed. Hey guys, thanks for taking our questions. One on Dan Mielza and then one on Burton Maps.
All participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for questions.
Our first question comes from Alec Stranahan with Bank of America. Please proceed.
Alec Stranahan: So for the Dan Mielza launch, I guess what are the next steps in your view to driving further access and or utilization, particularly after new treatment centers or ones that have recently been activated outside of MSK. And I guess how does the update scheme presented by Dr. Mora feed into this with grade three pain, then sort of a pushback from prescribers today. And then I've got to pull up.
Hey, guys. Thanks for taking our questions one on Daniels and then one on Burton.
But then we also launch I guess what are the next steps in your view to driving further access.
<unk> utilization, particularly up the new treatment centers or ones that have recently been activated outside of M. S. K and I guess, how does the up dosing scheme up presented by Dr. Mora feed into this has the grade three pain, then you know sort of a pushback from prescribers today, and then I've got a follow up.
Yeah.
Yeah.
Klaus Murlow: Yeah, let's take that first on Danielsa. And just the next steps are that we continue what we have been doing. We are reaching out to sites. It has been a little tricky during certain parts of 2021 to actually get in-person meetings, but that seems to have opened up now here in February this year, and we will continue expanding on that.
Yeah, let's let's take that first on the Danielle.
I'm just too that the next steps is that we continue what we have been doing we are reaching out to sites. It has been a little tricky doing a certain parts of 2021 to actually get.
In person meetings that seems to have opened up now here in February this year, and we will continue expanding on that and we are also receiving interest from sites on on providing product net net then yes, huh, Mike set them up for investigative sponsored studies and in particular, we are sponsoring a induction.
Klaus Murlow: But we are also receiving interest from sites on providing the product, Danielsa, Nexidermab, for investigator-sponsored studies. And in particular, we are sponsoring an induction treatment study where the patient, shortly after diagnosis, is receiving chemotherapy in combination with Nexidermab instead of just receiving chemotherapy prior to their surgery and radiation. So we are working with a number of sites on this, and there's also... increased interest from a number of sites to work with us on the vaccine, and we're working with the Children's Oncology Group, among others, to help them get access to our vaccine, our first study they would like to initiate themselves.
Treat study where the patient shortly after diagnosis is a receiving chemotherapy in combination. The next set them up instead of just receiving chemotherapy prior.
Prior to that sort of Japan radiation. So we are working with a number of sites in this and that's also.
An increased interest from a number of the sites to work with us on the vaccine and they're working with the children's oncology group among other to.
Help them getting access to our vaccine plus study they would like to initiate themselves.
Klaus Murlow: And so we are playing on a number of horses from the MSL side with the additional data that are also being generated directly by the sites where in the studies they want to start. We are continuing to inform them about the data that we are generating, and that will be coming out. We are hoping to present at ASCO some data from our chemotherapy and accelerometer combination, as well as hope that Dr. Mora will be allowed to present his step-up protocol.
So we are playing in a number of horses when the MSL side with the additional data that also being generated directed by the sites were in the study if they want to stop we are continuing to inform them about the data that we're generating and that will be coming out and we are hoping to present them at escrow some data from our chemotherapy and.
And next cinema combination as well as we are hoping that talk tomorrow will be allowed to percentage step up protocol right now we cannot use the data from Dr. Morris Our protocol in our sales and marketing activities, but it can stop tomorrow can talk to the sides. So not until he has presented data at ESMO.
Klaus Murlow: Right now, we cannot use the data from Dr. Mora's step-up protocol in our sales and marketing activities, but Dr. Mora can talk to the sites. So not until he has presented data at ASCO will we have a more formalized package that hopefully we can be allowed to use, unless the FDA agrees to let us do that first. But there's no doubt that the step-up procedure is simply facilitating the staff need for the infusion of Nexidermab. So instead of having a couple of nurses and a doctor bedside while the infusion goes on for about an hour, you can have the infusion for maybe two hours, but then only one nurse.
We have a more formalized package that that's hopefully we can be allowed to use unless the FDA agreed to let us do that first but there's no doubt that the step off procedures simply facilitating the staff need a far it with the infusion of mixing them up so instead of having a couple of nurses and a doctor peptides wildly intrusion goes on for about an hour.
Then you can have the infusion maybe for two hours, but then only one nurse that's how Dr. Morris experience that's been with us so.
Klaus Murlow: That's how Dr. Mora's experience has been with this. So those are, I think, some of the things that we are doing with Nexidermab. And in addition to, you can say, the more traditional stuff, we're also expanding activities on patient identification so we can do a more targeted approach. But we are continuing to expand to new sites, and we continue to see in the new year that additional new sites have shown interest in ordering products for treating patients. I hope that answers your question, Alec. Yeah, yeah. That's helpful and definitely encouraging. Thanks, Kyle.
So I think some of the things that we're doing for them like I said, I'm up and and inhibition to you can say the more traditional stuff. We also expanding activities on patient identification. So so we can do more targeted approach, but but we are continuing to expand to new sites and we continue to see.
Also in the new year that additional new sites have.
Shown interest and order product for treating patients.
I hope that answers your personality.
Klaus Murlow: And one more quick one on the EMBER map refiling: if I may, could you just talk to any remaining list items that you maybe need to check off in the FDA's view or for the tumor response data and the CMC discussion you provided sufficient for them? So, to the best of my understanding, all the information that we need is already there. And what we're doing right now is finalizing what are called final study reports on things to actually complete the clinical section and the safety section of the BLA filing.
Yeah, Yeah, that's that's helpful and definitely encouraging things close and one one more quick one on the M. Burt Mab Refiling. If I may could you just talk to any you know remaining list items you you maybe need to check off and the Fda's view are where the tumor response data and the CMC discussion you provided sufficient.
Sufficient for them.
To the best of my understanding all of the information that we need we have and what we're doing right. Now is we are finalizing what's called final study reports on things to to actually complete the the clinical section and in the safety section of the Asa.
BLA filing.
Klaus Murlow: So there's no, we're not waiting for additional stuff to come in. There's some discussion, the FDA wants to understand how they can actually, to which degree they can verify the historical control data in the Central German Cancer Registry in Cologne. But that's not something that is holding up the submission of the BLA filing.
So there's no we're not waiting for additional stuff to come in there's some discussion D. F. T. He wants to understand how they can actually to which degree they can verify the historical control data into central German cancer registry in Columbia, but that's not something that is holding up the submission of stuff the BLA file.
King.
Thank you.
Charles Zhou: Thank you. Our next question comes from Charles Zhou with Guggenheim Securities. Please proceed. Hi everyone.
Our next question comes from Charles Xu with Guggenheim Securities. Please proceed.
Yeah.
Charles Zhou: Thanks for taking my questions and happy Friday. Um, first one regarding UmbrtaMap, so it sounds like... The FDA refiling is going quite well and as planned. I had one question regarding the EMA feedback that you received. I think you mentioned that you received some feedback and questions from that agency. I guess, to what extent can your activities in addressing... FDA questions throughout 2021 be potentially applied to addressing the EMA questions that you raised, and could you provide any sorts of color around the questions that the EMA...
Hi, everyone. Thanks for taking my questions and happy Friday.
First one regarding burden so it sounds like the F. D. A refiling is going quite well and as planned though I had one question regarding the E. M. A feedback that you received I think you mentioned that you're that you received some feedback and questions from that agency I guess to what extent can.
Your activities and addressing FDA questions throughout 2021 be potentially applied to addressing the email questions that you raised and could you provide any sorts of color around just the question is that the EMA.
Charles Zhou: The e-mail questions have reflected almost precisely the questions that the FDA has raised in terms of comparison of data and propensity score balancing of patient cohorts, and so, I mean, maybe they just are thinking along the exact same lines, or they have been talking together. So that's also why, I mean, we are expecting to answer the e-mail questions at the same time as we are finalizing the Umberto Mapp BLA So it's basically the same types of questions. Got it. Sounds great. And also, regarding your GD2 SADA. That sounds like it's heading to the clinic soon.
The email questions have reflected almost precisely the question said.
She has raised in terms of a comparison of data in and.
Then city school balancing of of patient cohorts and so I mean, maybe they just are thinking along the exact same lines or they have been taught them together [laughter]. So that's also I mean, we are expecting to answer the email questions at the same time point as we are finalizing the.
Both of them, but.
BLA Resubmission.
So it's basically the same types of places.
Yeah.
Got it sounds great and also regarding your G D. Two Sato.
Asset that sounds like it's heading to the clinic soon how should we think about near term milestones and data releases coming out of that asset.
Klaus Murlow: How should we think about near-term milestones and data releases coming out of that asset? And I might have another follow-up. Yeah, I mean, the beauty of this side of technology is that we can immediately get the first very important answer to the question about this technology. Is it actually portable to have this?
A follow up on that as well thanks.
Yeah, I mean, the beauty of this sada technology is that we can immediately get the first very important answer to the question on this technology.
Is it actually possible to have this.
Klaus Murlow: I'm Bert. I'm at — oh, sorry, not me. -So the Lutetium construct, home to where the SATA molecule is sitting on the cancer. And we can see that on the SPECT scan we will be doing on the patients, basically from the first patient we dose. As soon as we get the SPECT scans, we can see if this actually works.
But up Oh, sorry.
Dota lutetium construct home to where the Sada molecule was sitting on the cancer and we can see that on the spec scan we will be doing on the patients.
From the first patient dosing and so unless we see the spect scans. We can see that it's actually work now I cannot guarantee that the first patient will be getting enough sought to cover the entire tumor tissue with sufficient amount of of lutetium 177, but the FDA has.
Klaus Murlow: Now I cannot guarantee that the first patient will be getting enough SATA to cover the entire tumor tissue with a sufficient amount of Lutetium-177, but the FDA has accepted that we are starting out with a total Lutetium dose of 100, I'm sorry, 200 millicuries of the isotope. So we're giving a quite high dose of the isotope; 200 millicuries is the same amount of radiation that's put into the seroproduct that is being given for the treatment of a neuroendocrine tumor.
Except that that'd be a starting out with the build of the teach them dosing of 100, I'm, sorry, 200 medically off the isotope. So we're giving a quite high dose of the isotope 200 medical raise the same amount of radiation that's put to them to Sarah product that is being giving given for treatment of neuro endocrine tumors. So so.
Klaus Murlow: So the radiation dose is of the same magnitude as what is normally being used with curative intent per dose. And now, will the amount of protein that we can give for the first patient be enough to cover a sufficient amount of the tumor to actually also get the entire thing radiated? That's probably more of a bit to the question, but there are some things we will also be exploring. But very early on, and I hope, definitely, at our R&D day later this year that we'll be able to share with you some of the first data findings from this study and the scans from these patients. I'm very, very excited about this and if, I mean, unless I completely misunderstand something about radio physics, then if you put radiation on a cancer, it's going to kill it.
The radiation dose is in the same magnitude as far as what is normally being used with curative intent.
So it put a dose and and now will the amount of protein that we can give for the first patients would be enough to cover sufficient amount is that too much actually also get d'etats ingredient, that's probably more but to the question, but there are some things also we will be exploring that so but very early on and I hope definitely at our R&D day later this year.
We will be able to share with you. Some of the first date of findings from this study in the scans from these patients.
I'm very very excited about this and and <unk> I mean.
That's completely misunderstood something about radio physics, and if you put radiation to a cancer, it's gonna kill it.
Klaus Murlow: Now, of course, there has to be enough of it, but if this works, it really should have tremendous potential. So we'll get that answer very early on. Did you have a follow-up for this, Anna? Yes, yes. Thanks.
Now of course that has to be enough of it but but then so if this works.
It's it's really should have tremendous potential.
So we can get that answer very early on did you have a follow up from the southern.
Klaus Murlow: Just one quick follow-up on that. So, it does sound like, you know, you could potentially have some initial imaging data, you know, maybe at your R&D day by year end. I am kind of wondering, you know, like how should we think about, you know, I guess from a quantitative perspective, you know, like what the imaging data could tell us about, you know, dosimetry as well as localization given that, you know, lutetium-177 isn't quite a purely diagnostic isotope and you may be exploring some of the lower doses first. No, no, I, I, I It's a beta emitter with a half-life of about six days and a pretty high energy.
Yes, yes. Thanks, just one quick follow up on that so it does sound like you know you could potentially have some initial imaging data maybe at your R&D day.
I am kind of wondering how should we think about you know I guess from a quantitative perspective, you know like what the imaging data could tell us about you know dose symmetry as well as localization given that the TCE of 177.
<unk> eight shortly.
Diagnostic I used to have and you may be exploring some of the lower doses.
No no.
Lutetium is Ah is hum.
It's a curative isotope it's a beta ended up with a half life of about six days and at a pretty high energy and and that will be killing cells up to one millimeter from where I'm sitting and and as I said the dose of the teach them. We are using which is 200 military of the teach them and daughter molecules is the same dose that is being used for.
Klaus Murlow: And that will be killing cells up to one millimeter from where it's sitting. And as I said, the dose of lutetium we are using, which is 200 milligrams of lutetium in DOTA molecules, is the same dose that is being used for Lutasera. And then Lutasera is given bimonthly for up to four doses of 200 milliary. But the total dose that we are sticking into the first patient that will receive a SATA molecule is also 200 milliary of lutetium-177. So it's potentially a treatment. But will there be enough protein sitting on cancers that the DOTA molecule can bind to?
Due to Sarah and then Luca.
Sarah is given.
By monthly for up to four doses of 200 military but the children dose would be sticking into the first patient that will receive a sada molecule is also 200 medically of of the teach them. A 177. So it's it's potentially a treatment will that be enough protein sitting on Kansas.
That the dota molecule can bind to that that is probably problematic. Since we are dose escalating on on the protein on the antibody construct also.
Klaus Murlow: That is probably problematic since we have dose escalating on the protein on the antibody construct also, and we may have to go to higher doses of antibody before we get a sufficient amount of binding. But the SPECT scans that we'll be doing, where you can image things that are beta radiation emitting, then they should show up. And we can superimpose those SPECT scans on the MR scans from the patient and see if the technology actually works.
And we may have to go through to higher doses of antibody before we get sufficient amount of binding so but the spec scans that we'll be doing that that way you can image things will that be done radiation emitting.
Then they they should show and we can supine pozos spect scans on the MRI scans from the patient and see does the technology actually work will it actually home to the Kansas. So so I think we will get some quite important information early on.
Klaus Murlow: Will it actually go to the cancer? So I think we will get some quite important information early on. Understandable. Thanks for that, Culler and Clare. Thank you, Charles.
Yeah.
Understood Thanks for that color and clarification.
Thank you Jess.
Yeah.
Mike Ulz: Our next question comes from Mike Ulz with Morgan Stanley. Please proceed. Yeah. Hi guys.
Our next question comes from Mike <unk> with Morgan Stanley . Please proceed.
Yeah, Hi, guys. Thanks for taking the question.
Mike Ulz: Thanks for taking the question. Just one on Danielsa and the label expansion strategy. Wondering if you can give us an update on the frontline neuroblastoma study, you know, in terms of where you are in enrollment. I think at the R&D day, you were also considering adding a new cohort with the new dosing protocol. Just curious if you made a decision on that.
Just one on Danielle so and the label expansion strategy.
I was wondering if you can give us an update on the frontline Neuroblastoma study you know in terms of where you are in enrollment I think at the R&D day, you were also considering adding a new cohort with the new dosing protocol. Just just curious if you've made a decision there and is it possible that we might see some data from this study later this year.
Klaus Murlow: And is it possible that we might see some data from this study later this year? I think it's highly likely that the front-line study from MSK will be published later this year. It's 59 patients in the front-line setting who have not yet been published. The only data we have published in the front-line setting is the data from Dr. Moore's side in Barcelona.
Thanks.
I think it's highly likely that the frontline study for my Miss cable will be published later this year. It's 59 patients in the frontline setting that has not yet been published are the only data we have published in the frontline setting as the data from Dr. Morris site in Barcelona.
Klaus Murlow: And as I said, we are also working with the Beating Childhood Cancer Group, which is a consortium of more than 40 sites in the U.S., and more than half of them are also COG members, where more than 30 hospitals have said they want to participate in our front-line study where we are giving Danielsa together with chemotherapy in the induction setting before surgery and radiation and bone marrow transplant and additional chemo, et cetera And in that study, we are also considering, since it's an investigator-sponsored study, it's at the discretion of the investigators. To randomize between dynatoxamab and mexidamab in a front-line setting in patients that are in their first complete remission.
And as I said, we are working also with wind they're a beating.
Beating childhood cancer group, which is a consortium of more than 40 sites in the U S and more than half of them also a few team members were up more than 30. After hospitals have said they want to participate in our frontline study, whether you're giving danielle so indeed to get up and chemotherapy in the induction setting.
Before surgery, and radiation and bone marrow transplant, and additional chemo et cetera, and in that study. We are also considering since it's an investigator sponsored study it's at the discretion of the investigators, but two randomized between Diana took some up and set them up in frontline setting and in patients that I first complete.
Permission.
Got it thank you.
Yeah.
Joseph Tomey: Got it, thank you. Our next question comes from Joseph Tomey with Cowan & Company. Please proceed. Heather, good morning, and thank you for taking our questions. Maybe on the SADA platform, I know you mentioned potential partnership strategies there, so can you talk about that a little bit? How many deals are you looking to do for the SADA platform, and maybe what targets or indications do you want to have fully in-house? And then, second, on the Daniella launch, once some of these new centers do come online and get trial shipments or vial shipments, do they tend to be reorderers? Can you talk about the frequency there?
Our next question comes from Joseph told me with Cowen and company. Please proceed.
Hi, there good morning, and thank you for taking my questions maybe on the Sada platform. I know you mentioned potential partnership strategies. There. So can you talk about that a little bit how many deals are you looking to do for the Sada platform and maybe what targets or indications do you want to keep fully in house and then second on the other.
Danielle as a launch once some of these new centers do come online and get trial shipments our final shipments do they tend to be Reorders can you talk about the frequency there.
Klaus Murlow: Yeah, maybe I can answer Daniel's question first, and then Thomas can elaborate on the SADA partnerships and what we're doing there. But yes, we are definitely seeing reorders, and it's a little fluctuating. I think our third biggest site in the U.S. right now has never actually accepted to see any of our sales team but, nevertheless, they have been ordering and reordering for a number of treatments. So yes, we are definitely seeing that, but I think we are in the early stages.
Yeah, maybe I can answer the Daniela So first and then Thomas can you elaborate on the on this sort of partnerships and in what we're doing there, but but yes, we are definitely seeing reorders and and it's a little bearing I think our biggest side in the U S. Right now has never actually.
Accepted to C N F. Our sales team, but but but nevertheless had been ordering and reordering for a number of treatments. So so yes, we are definitely seeing that but but but I think we are in the early states right now still a and as I said also.
Klaus Murlow: Right now, still, and as I said also, you know, I had a call with one of the COG leaders recently, and she said to me during that call that, hey, I mean, it's laborious to give Danielsa. I'm the only doctor here at this hospital that can sit bedside when we give it.
You know I had a call we want us to C. O G D. Just recently.
And she said to me during that call that Hey, I mean.
It's labor some to give danielle so I'm the only doctor. He had this hospital that can sit bedside.
When we gave it and and therefore.
Klaus Murlow: And and therefore we need to get the system up and running. But but I'm definitely continuing to use Nexidermab. But hey.
We need to get the system up and running but but I'm definitely continuing to use like I said I'm not but hey.
Klaus Murlow: Trust me, it was exactly the same when we started out with inotoximab, and I've been involved in that development all along. But now everything is working because we've been doing it for so many years now. And so this will come.
Trust me it was exactly the same when we started out with Daimler trucks a month.
And I've been involved in that development all along.
And but now everything is running because we've been doing it for so many years now and and so this will come. So it's just to say that yes. There are some hurdles, but the doctors are not stupid. They also remember most of those that are you can say long term users of uptime. It talks about they remembered how they needed to learn to give done it took some I've also in.
Klaus Murlow: So it's just to say that, yes, there are some hurdles, but doctors are not stupid. They also remember most of those that are, you can say, long-term users of dinatoxamab. They remembered how they needed to learn to give dinatoxamab also in the beginning. And now they have ended up with this humongous, laborious process where it takes almost a week to treat a patient. And they have to be in the hospital intensive care unit, admitted all along, although they're handling all the practicalities around it pretty easily. And so the same goes for Danielle.
The beginning and now they have ended up with this humongous LAPIS process, where it takes almost a week to treat a patient and then they have to be in the hospital intensive care unit admitted all along although they are handling all the practicalities around it pretty easily and so the same goes for Florida, Danielle so they they need to get used to it they nurses.
Klaus Murlow: So they need to get used to it. The nurses also need to get used to kind of handling the patients and the infusion. I think with the step-up dosing, we are really making a significant leap forward to helping when we can publish these data and start implementing them at the sites for the hospitals to have a lot easier access to treating these patients. But then, with that, I'm going to let Thomas comment on the partnering plans for SATA. Thomas?
You need to get used to.
Kind of like handling the patients in the infusion I think with the step up dosing, we are really making a significant leap forward to helping when we can publish these data and start implementing them on the sites for the hospitals to have a lot easier access to treating these patients.
But then with that I'm going to let Thomas comment on the partnering plans for Astana Thomas Yeah. Yeah. Thank you klas. So we are in discussions with multiple companies about our own targets, but also importantly third party targets S.
Thomas Gad: Yeah, yeah. Thank you, Klaus. So we are in discussions with multiple companies about our own targets but also, importantly, third-party targets. Thank you. Talk to partners about other targets, their own targets, and we can optimize our platform for these targets. So the strategy is to
All licensing agreement is structured in a way that we can.
Talk to partners about all the targets their own pockets and we can optimize our platform for these targets.
So the strategy is to.
Thomas Gad: Definitely talk about partnerships for large adult indications. Maybe pick out the pediatric patients and populations, but also, importantly, talk to companies on their own targets. Our next question comes from Tessa Romero with J.P. Morgan. Please proceed. Hey guys, hope everyone is doing well.
Definitely talk about partnerships for large adult indications, maybe carve out for pediatric patients.
Operations, Hum and but also importantly talk to companies on their own targets.
<unk> targets.
Alright, Thank you very much.
Our next question comes from Tessa Romero with Jpmorgan. Please proceed.
Hey, guys hope everyone is doing well.
Tessa Romero: Thanks so much for taking our questions. So I think consensus for Danyalza is getting around $78 million, which would imply, I think, about a doubling of sales versus 2021. In your view, what are the levers for exceeding this number, and what kind of keeps you up at night? Thanks so much. Hey, Tez.
So much for taking our question.
So I think confronted Danielle.
Marion.
Which would imply I think a lot of gambling.
2021 .
And you're in your view what are the leverage right.
Hmm.
Thanks, so much.
Klaus Murlow: Well, we haven't given any guidance for this year for sales of Danielsa. Taking from last year, it would be 64 point something million. But I think we have given absolutely no guidance in that direction, and I think it's still too early.
I think that Oh, well, we haven't given any guidance for them.
For this year for sales of Daniel's huh.
And adult learning from last year would be 64 point something million, but but I think we have given absolutely no guidance in that direction and I think it's still too early I mean, we saw an increase from second to third quarter and 10% of the increase in vials are we saw an increase from surgery.
Klaus Murlow: I mean, we saw an increase from second to third quarter of 10 percent in vials. We saw an increase from third to fourth quarter of about 7 percent. And that was in – the rebates in the third and fourth quarter were basically the same.
Fourth quarter off about 7% and that was in the rebates and certain fourth quarter, but basically the same. So it's also reflecting a similar increase in sales.
Klaus Murlow: So it's also reflecting a similar increase in sales of vials. But I still think this is still so early on in terms of adoption and the kind of patients that are actually being treated. So I think – Bo, do you have any comments also in terms of market expectations? Yeah, I think that you're right in that the average expectation is 78% when it's true.
Sales of buyouts I still I still think of it. This is still so early on in terms of adoption and the kind of patients that I actually being treated so I thank them.
Bo do you have any comments also in terms of market expectations, Yeah, I think you're right in that the average if you take 78, but when it's true.
If we narrowed down to just look at the analyst reports most recently updated its been quite a bit lower than that so what I'm trying to say is that in the.
Bo Kruse: If we narrow it down to just look at the analyst reports most recently updated, it's quite a bit lower than that. So what I'm trying to say is that in the average number, there are some quite updated reports in there. Not that we will get to 78 million, but it's just that it's maybe a little bit overstretched.
Average number there are some.
White Oak dated reports in there not that we will get to 78 million, but it's just that it's maybe a little bit of a stretch for this year.
Bo Kruse: We'll do our absolute best to see if we can live up to that, but I just don't want to give any guarantees. OK. All guidance. Thanks, thanks, cross-embow.
But we will do our absolute best to see if we can live up to that but I just don't want to give any guarantees [laughter].
Oh called guidance.
Tessa Romero: I just, one more if I could squeeze one in. You know, that cash runway through the end of 2023. Are you able to provide any kind of rough guidance on expenses in 2022 and how that breaks out between SG&A and R&D? (inaudible) We haven't provided any guidance, but it's one and two. I would expect it to be reasonably in line with what you saw last year. And even if you look at the year before that, again, in 2020, we had operating expenses of $141 billion. And then in 2021, we had $150 million.
Thanks.
And just one more if I could squeeze it wine.
And you know we're not in a classroom.
2023.
Are you able to provide any kind of rough.
2020, and how that breaks out.
90.
Bo Kruse: So it's not that he would expect to see some sort of dramatic increase. I would assume it to be recent. Okay. Thanks so much for taking the question. Absolutely.
We haven't provided any guidance, but it's when it too, but I would expect them to where you'd be reasonably in line with what you've seen last.
Last year and then even if you look at the year before that like in 2020, we had operating expenses of 141 billion and then in 'twenty, one we had $150 million.
So it's not that he would expect to see some sort of a dramatic increase I would assume it would be we used to before.
Okay.
Okay.
Thanks, so much for taking my question.
Absolutely.
Sebastian Venderskoop: Our next question comes from Sebastian Venderskoop with Kempen. Please proceed. Hi team.
Our next question comes from Sebastian vendors group with Kempen. Please proceed.
Yeah.
Sebastian Venderskoop: Thanks for joining us and taking my questions. The first one concerns the use of the nails and the real setting, first, the clinic. Can you also explain how many nails are used for patients in the clinic, in the real world versus the clinical setting? And can you also maybe talk a little bit about the difference between MSK and other study centers?
Hi team thanks for it other than the taking my question.
The first one regarding the use of the Nielsen real setting for the clinic.
Can you expound on how many felt I used per patient.
And the.
In the real world versus the clinical setting and can you also maybe.
Talk a little bit about the difference between MFA and others and then the second question is on there.
Klaus Murlow: And then the second question is on the rest of the pipeline beyond Laxitamab. Can you expand on what clinical data updates we are expecting in 2020? Thank you, Sebastian.
Rest of the bike line beyond the feed them up can you expect the expense on the both clinical data updates we are expecting in 2022.
Thank you Sebastian we don't.
Klaus Murlow: We haven't given any numbers on the number of vials per patient, but what I can say is that in clinical studies 201 and 12230, the average number of cycles of treatment per patient was about 5.6. And what we are seeing is that in patients that are equivalent to the patients in these two studies, the number of cycles is the same, but we also see many new sites that are starting out with patients that are way later in their disease development than the patients in those studies.
We haven't given any numbers on the number of vials per patient what I can say is that in in the clinical study 201 in 12 to 30, the average number of cycles of treatments.
If a patient was about 5.6 and what we are seeing is that in patients that are.
Equivalent to their patients in these two studies.
A number of miles Oh, there are a number of cycles are the same but we also see many new sites that are starting off with patients that are way later in their disease development than the patients in those studies and that means that they are actually progressing after having received a number of cycles that span. It took some up in chemotherapy in.
Klaus Murlow: And that means that they are actually progressing after having received a number of cycles of spina toxoma and chemotherapy, and then rather than just sending them home with palliative therapy, then they try a couple of cycles of nexidermab on these patients, and that becomes then their first experience. And obviously, then the number of vials and the number of cycles go down.
And then rather than just sending them home but.
Palliative therapy, then they try a couple of cycles of ethnic set them up on these patients and that becomes then their first experience and obviously then the number of biopsies and and the number of segments goes down.
Klaus Murlow: In terms of the difference between MSK and the rest of the sites, the MSK sites, the MSK people, I mean, like I just told you about the COD investigator I talked to who had many years of experience with dinotoxin maps and said that in the beginning it was really a major effort for us to treat those patients, and now everything is standardized, and we're so used to it, and it's no longer considered an issue. The MSK side has been dealing with this product for so long, so they don't need a doctor's advice just because they're dosing. They have several patients being dosed at the same time with some nurses looking after them, and, of course, the ability to get a doctor in the room is needed, but very rarely is that needed.
In terms of the difference between M S K and in the rest of Society Emma's case sites.
S K.
Like I just told you about the D C O T investigator I talked to.
That has many years of experience with Bavituximab and said that in the beginning it was really a major effort for us to treat those patients and now everything is standardized anyway. So used to it and there is no longer considered an issue.
Yeah. The M. S. K side had been dealing with this product for so long time, so they they don't need a doctor bedside, just because they're dosing they had to say about patients being dosed at the same time with some nurses looking outside and and of course, there's the ability to get a doctor in the room, if needed, but very rarely that is needed so for.
Klaus Murlow: So for them, it's just a normal day on the job, whereas the new teams have to work a bit harder to get comfortable with how they handle the reactions to the Nierse product. So there, and again, also as it just eluded through with the number of vials, outside of MSK, the product is often being used at later stages, unless it's because the parents insist that they want to get treated with Daniel Fed, which also happens. And so that is another difference between MSK and the size outside.
It's just a normal day on the job with the new sites have to work a bit harder to get comfortable on how they handle their their reactions to them the Daniels product.
Klaus Murlow: And that will change as we continue to work with the size and they get more experience, et cetera. And I think, I hope my point was well taken about the beating child cancer study that is expected to start this summer, that includes 30 sites, more than 30 sites of which no more than 10 of them have previously been used next to the map. So that, in itself, is going to add another 15 to 20 sites that have never been practically used next to the map. And then they get clinical trial experience, and they can also use it at the same time with patients on the commercial side.
So I sit there and and again also as I just alluded to with the number of vials outside of M. S. K. The product is often being used at later stages.
Unless it's because the parents insist that they want that kid treated with Daniels had which also happens and and so that is another difference between emiscan the sites outside and and that will change as we continue to.
Work with the sites and they get more experience etcetera, and and I think I Hope My point was well taken about the beating childhood cancer study that is expected to start this summer.
That's including 70 sites more than 70 sites of which.
No more than 10 of them had previously been using a next set them up so that in itself is going to add another 15 to 20 sites that have never been practically using next set them up and then they get clinical trial experience and they can also use it at the same time Ah patients that on the commercial side. So that's really a major are important.
Klaus Murlow: So, that's really a major important thing for us. In terms of data, I just eluded to that we expect ASCO to have some data presented on the chemo combination next to the map with the wing of chicken and MSOlemide from a data compilation made by MSK and Dr. Mora. And we also expect Dr. Mora's study to be presented there. And then later this year, we expect also to have data from the 59 patient frontline study at MSK.
I think for us.
In terms of data I, just alluded to that would be expected to have some data presented on the chemo combination of next set them up with the chicken in semis LMI.
From from Am data compilation made by a M. S K and talk Tomorrow, and we also expect off the Morris study to be presented there and then later this year. We expect also to have data from the 59 patient frontline study I didn't Miss Kay.
Klaus Murlow: And then there may be something else, but those are the ones that we are right now focusing on. But so there will be a number of additional data sets presented for 10 years later this year. Okay, thank you. And then regarding the rest of the pipeline, can you maybe, beyond Daniel, do you have other clinical readouts? Or the rest of the pipeline that would definitely be updates from the... [inaudible] Great.
And then there may be something else, but those are the ones that that we have right now are focusing on but so there will be a number of additional datasets presented four then yesterday there this year.
Okay. Thank you and then regarding the rest of the pipeline came to be beyond Daniels Linda Yes, there are 10-K orea.
Right.
Oh.
Oh, the rest of the pipeline that would be definitely updates from the.
From Oh on both of my studies, both in the CNS, let somebody go metastasis, we would be hopefully finding a suitable venue to present data from the 101 study, including tumor response, and a progression free Shaw event free survival and overall survival from that study and we will.
Also be having hopefully the additional data presentations on the D. I P. T study by Dr amongst where they in from Cornell M. S. K Ah that have done the phase one dose escalation study there.
And that's I think in line with what I've said earlier also we are hoping to have the first data from the survey at L. A and D day, and hopefully also some additional update on our bi specific platform.
Klaus Murlow: Thank you, Klaus. Thank you. Ladies and gentlemen, we have reached the end of the question and answer session. I'd like to turn the call back to Thomas Gad for any closing comments. Thank you very much, everybody, for joining today. This concludes our earnings call. Have a great weekend. Thank you.
Okay, great. Thank you Klaus.
Yeah.
Thank you.
Ladies and gentlemen, we've ever seen with a question and answer session I'd like to turn the call back to Tom's got for any closing comments.
Thank you very much everybody for joining today. This concludes our earnings call and have a great weekend. Thank you.
Yeah.
This concludes today's conference you may now disconnect.
Yeah.
Yeah.
Okay.