Q4 2023 Y-mAbs Therapeutics Inc Earnings Call

Operator: The Ultimate Parody Site! The Bulletproof Executive, 2013, BF-WATCH TV 2021 The Bulletproof Executive, 2013, The Ultimate Parody Site! www.globalonenessproject.org The Ultimate Parody Site! BF-WATCH TV 2021, The Bulletproof Executive 2013 All rights reserved, www.microsoft.com.au The Bulletproof Executive 2013, Good morning, and welcome to the Y-mAbs Therapeutics Earnings Conference Call for the fourth quarter and full year of 2023. At this time, all participants are in a listen-only mode.

Hello.

[music].

Yeah.

Speaker Change: Good morning, and welcome to the Wimax Therapeutics earnings conference call for the fourth quarter and full year of 2023 at this time all participants are in a listen only mode instructions for the question and answer session will follow after the prepared remarks.

Operator: Instructions for the question-and-answer session will follow after the prepared remarks. As a reminder, today's conference will be recorded. I'll now turn the call over to Y-mAbs Head of Investor Relations, Courtney Dugan. Thank you, Operator, and good morning.

Speaker Change: As a reminder, today's conference will be recorded I'll now turn the call over to why mobs head of Investor Relations Courtney Dugan.

Courtney Dugan: Thank you operator, and good morning, everyone welcome to the Y knot fourth quarter and full year 2023 financial results Conference call.

Courtney Dugan: Welcome to the Y-mAbs fourth quarter and full year 2023 financial results conference. We issued a press release with our results yesterday after the market. The press release and accompanying slides are available on the IR section of the website. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking, as defined in the Private Securities Litigation Reform Act of 1995.

Courtney Dugan: Issued a press release with our results yesterday after market close.

Courtney Dugan: Press release and accompanying slides are available on the IR section of our website.

Courtney Dugan: Let me quickly remind you that the following discussion contains certain statements that are considered forward looking statements.

Courtney Dugan: Private Securities Litigation Reform Act of 1995.

Courtney Dugan: Such statements include, but are not limited to... Statements about our business model and development, commercialization, and product distribution. Thank you. Expectations related to the timing of initiation and completion of regulatory submissions. Regulatory, Marketing, and Reimbursement Approvals, including statements with respect to future development of other developments. Thank you for joining us. Thank you. Potential of and Advancement of FODMAP.

Courtney Dugan: Such statements include but are not limited to statements about our business model and development commercialization and product distribution plans expectations with respect to early trial data current and future clinical and preclinical studies and a richer research and development for our brands.

Courtney Dugan: Expectations related to the timing of initiation and completion of regulatory submissions regulatory marketing and reimbursement approvals, including statements with respect to future development or other development programs potential for Daniels of territory and label expansion and potential of an advancement of Florida.

Courtney Dugan: Collaborations for strategic partnerships and the potential benefits thereof.

Courtney Dugan: Collaborations or strategic partnerships and the potential benefits thereof. Expectations related to our anticipated cash runway and the sufficiency of our cash resources and assumptions related thereto. The items and expectations for 2024 and beyond and our financial performance, including our estimates regarding revenues, expenses, and capital expenditures, and other statements that are not historical. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed throughout these four 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 year ended December 31 As filed with the SEC on February 29th, 2020. [inaudible] Thank you, Courtney.

Courtney Dugan: Expectations related to our anticipated cash runway and the sufficiency of our cash resources and assumptions related thereto.

Courtney Dugan: Vince and expectations for 2024, and beyond and our financial performance, including our estimates regarding revenues expenses and capital expenditure requirements and.

Courtney Dugan: And other statements that are not historical facts.

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 report on Form 10-K for the year ended.

December 31st 2023 as filed with the SEC on February 29 2024.

Courtney Dugan: With that I'd like to now turn the call over to our President and CEO, Mike Rossi.

Michael Rossi: Good morning, everybody, and thank you for joining me today. I have with me today our Chief Financial Officer, Bo Kraus. Our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Dr. Vignesh Rajah Thomas Gad, our Founder and Chief Business Officer, and Dr. Steen Lisby, our Chief Scientific Officer, will join us for the Q&A portion of this call. On today's call, I will begin by reviewing our fourth quarter and full year 2023 Global Highlights on Danielle DeSales, and updates on our clinical program utilizing our self-assembly, disassembly, pre-targeted radio-i Next, Sue will report further insights into our global Danielza sales in the fourth quarter. Vignesh will then provide updates on our ongoing Sinemad clinical trial. Bo will then provide an overview of our fourth quarter and full year 2023 financial performance, our cash resources, and our full year 2024 guidance before we open the line for Q&A. 2023 was an important year for Y-mAbs.

Michael Rossi: Thank you Courtney and good morning.

Michael Rossi: Everybody and thank you for joining us.

Michael Rossi: I have with me today are Chief Financial Officer, Bo Crouch, our Chief commercial Officer Sue Smith.

Michael Rossi: And our Chief Medical Officer, Dr. Rudolf.

Michael Rossi: How much that our founder and Chief business Officer, and Doctor stimulus via our Chief Scientific Officer will join us for the Q&A portion of this call.

On today's call I will begin by reviewing our fourth quarter and full year 2023 global highlights I'm Danielle themselves and updates on our clinical program utilizing our self assembly disassembly pre targeted radio immune therapy or sort of like the.

Michael Rossi: Algae platform.

Michael Rossi: Next she will report further insights into our global Daniels with sales in the fourth quarter.

The Nash will then provide updates on our ongoing clinical trials.

Michael Rossi: Paul will then provide an overview of our fourth quarter and full year 2023 financial performance.

Michael Rossi: Resources and our full year 2024 guidance before we open the line for Q&A.

Michael Rossi: Okay.

Michael Rossi: 2023 was an important year for why mobs with the completion of our restructuring plan earlier last year why labs emerged as an innovator and radiopharmaceutical therapy development based on our novel and differentiated pre targeted radio immunotherapy platform chocolate.

Michael Rossi: With the completion of our restructuring plan earlier last year, Y-mAbs emerged as an innovator in radiopharmaceutical therapy development based on our novel and differentiated pre-targeted radioimmune therapy platform, SodaPrip, which complements our Commercial Antibody Therapy, Danielza, driving annual revenue growth. In addition to our more focused pipeline, we reduced our use of cash to only $27.1 million in the full year 2023 as a direct result of our effective capital management strategy and action. With $78.6 million in cash and cash equivalents as of December 31st, 2023.

Michael Rossi: Complemented by our commercial antibody therapy Daniels I'll try.

Annual revenue growth.

In addition to our more focused pipeline, we reduced our cash use of cash to only $27 1 million in the full year 2023 is a direct result of our effective capital management strategy in action.

Michael Rossi: With $78 6 million in cash and cash equivalents as of December 31, 2023.

Michael Rossi: We believe we have sufficient financial resources to advance the clinical development of our SADA print platform while continuing our efforts to expand our global geographic footprint of Danielta and treat more patients impacted by relapsed or refractory high-risk neuroblastoma. I'd be remiss not to mention the incredible hard work and dedication of our Y-mAbs employees. They've made all this progress possible, and I'm very proud to work alongside team members who put patients at the forefront of all that they do day in and day out. Now, let's dive into the key highlights for our fourth quarter and full year 2023, starting with Danielza. For anyone who may be newer to Y-mAbs, let me remind you that Danielza is approved by the US FDA for the treatment of relapsed or refractory high-risk neuroblastomas in the bone or bone marrow for patients who have demonstrated a partial response, minor response, or stable disease with prior therapy. Neuroblastoma is the most common cancer in infants and the third most common cancer in children.

Michael Rossi: Believe we have sufficient financial resources to advance the clinical development of our Sada platform well continue our efforts to expand our global geographic footprint I'm Danielle.

Michael Rossi: Treat more patients impacted by relapsed or refractory high risk neuroblastoma.

Michael Rossi: I'd be remiss not to mention the incredible hard work and dedication of our one notch employees they've made all this progress possible and I'm very proud to work alongside a team members who put patients at the forefront of all that they do day in and day out.

Michael Rossi: Now, let's dive into the key highlights for our fourth quarter and full year 2023, starting with Daniels.

Michael Rossi: For anyone who may be newer to why mobs, let me remind you that daniels's approved in the U S approved by the U S. F D. A.

Michael Rossi: Treatment of relapsed or refractory high risk neuroblastoma is in the bone or bone marrow for patients who have demonstrated a partial response minor response or stable disease with prior therapies.

Michael Rossi: Blackstone is the most common cancer in insurance the third most common cancer in children.

Michael Rossi: We finished 2023 on a strong note achieving $23 4 million in net product sales of Daniels in the fourth quarter, an increase of 42% from what we recorded in the fourth quarter of 2022.

Michael Rossi: We finished 2023 on a strong note, achieving $23.4 million in net product sales for Danielle's in the fourth quarter, an increase of 42% from what we recorded in the fourth quarter of 2022 and an increase of 17% versus the third quarter of 2023. Through continued market penetration across high-volume U.S. accounts and in ex-U.S. regions, we are pleased to have achieved an annual 2023 net product revenue for Danielza of $84.3 million, which was near the top end of our previously raised guidance range of between $80 and $85 million. This was an increase of 71% compared to the full year 2022.

An increase of 17% versus the third quarter of 2023.

Michael Rossi: Through continued market penetration across high volume U S accounts ex U S regions. We're pleased to have achieved an annual 2023 net product revenue for Danielle.

Michael Rossi: The $84 $3 million, which was near the top end of our previously raised guidance range of between 80 and 85 million.

Michael Rossi: This was an increase of 71% compared to full year 2022.

Michael Rossi: The progress is remarkable and indicates increasing adoption of Daniels, our cross approved regions worldwide.

Michael Rossi: The progress is remarkable and indicates increasing adoption of Danielza across approved regions worldwide. We continue to gain momentum in the U.S. with a number of new accounts. As of December 31st, 2023, we had 58 active sites across the U.S. since Daniela's initial launch, with 10 new accounts added in 2023. Our international footprint continues to expand through multiple partnerships. The Danielza launch in China is progressing well, and this January, we accepted the price for Danielza from the Brazilian Medicines Market Regulation Chamber, or CMED. We expect to launch Danielle's in Brazil and Mexico in the second quarter of this year with our partner ADM, and look forward to providing progress updates on this anticipated launch in the coming quarter.

Michael Rossi: We continue to gain momentum in the U S with a number of new accounts.

Michael Rossi: As of December 31, 2023, with 58 active sites across the U S. Since Daniels its initial launch.

Michael Rossi: 10, new accounts at it in 2023.

Michael Rossi: Our ex U S footprint continues to expand through multiple partnerships.

The Daniels will launch in China is progressing well and this January we accepted the price for getting all of that from the Brazilian medicines market regulation chamber or C. M D.

We expect to launch Daniels in Brazil, and Mexico in the second quarter of this year with our partner idea.

Michael Rossi: And look forward to providing progress updates unless they anticipate a launch in the coming quarters.

Michael Rossi: Our European Early Access Program with Web Pharma Clinical is continuing to progress as we support the needs of children with high-risk relapsed refractory neuroblastoma in Europe. In addition, we plan to submit a VLA for Danielle in Argentina this year and could potentially receive additional approval in Asia, in Hong Kong, within the next 18 months. In addition to geographic expansion, we continue to see progress among our ongoing ISS-sponsored Nexidimab trials in support of our indication expansion strategy. In particular, we look forward to Memorial Sloan Kettering's readout from its multi-center phase two trial investigating nexidymab in patients with relapsed osteosarcoma in the fourth quarter of this year. You will hear more about the progress of the ongoing Nexida web trials from Vignesh later on in this call. Now, let me shift to our SADA PREP platform. Before I provide a brief update on our LEAD programs, I want to take a moment to set the stage for some of the current challenges related to commercialization, administration, and manufacturing infrastructure for targeted radiopharmaceutical therapy. There are four key areas. First, Infrastructure and Manufacturing.

Our European early access program with what pharma clinical cause.

Michael Rossi: It's continuing to progress as we support the needs of children with high risk relapsed refractory neuroblastoma in Europe.

Michael Rossi: In addition, we plan to submit a BLA for Daniels in Argentina. This year it could potentially receive additional approvals in Asia in Hong Kong within the next 18 months.

Michael Rossi: In addition to geographic expansion, we continue to see progress among our ongoing I S. S sponsored exiting lab trials in support of our indication expansion strategy.

Michael Rossi: In particular, we look forward to memorial Sloan Kettering is read out from its multicenter phase two trial investigating the matter in patients with relapsed.

Michael Rossi: I'll steal sarcoma in the fourth quarter of this year.

Michael Rossi: You'll hear more about the progress of the alcoholic next set of trials from the batch later on this call.

Now, let me shift to our startup great platform.

Before I provide a brief update on our lead programs I wanted to take a moment and set the stage without some of the current challenges related to commercialization administration.

Michael Rossi: In manufacturing infrastructure of targeted radiopharmaceutical therapies.

Michael Rossi: There are four key areas.

Michael Rossi: First infrastructure manufacturing there's.

Michael Rossi: There's an enormous investment currently ongoing into specialized radiopharmaceutical manufacturing facilities where targeted radiopharmaceutical therapy is made. Once the therapy is made and released, there's a very limited time window to deliver that therapy to patients before it expires. Second, physician participation, which has always been an issue. With current radiopharmaceuticals, the oncologist needs to refer the patient to an authorized physician that can prescribe and administer radiopharmaceuticals, traditionally a nuclear medicine physician.

Michael Rossi: There's an enormous investment currently ongoing and two specialized radiopharmaceutical manufacturing facilities for targeted radiopharmaceutical therapy is made.

Michael Rossi: Once the therapy is made and released there's a very limited time window, which to deliver that therapy to patients before it expires.

Michael Rossi: Second as physician participation, which has always been an issue.

Michael Rossi: With current Radiopharmaceuticals, the oncologist needs to refer the patient to an authorized physician that can prescribe to administer radiopharmaceuticals traditionally in nuclear medicine physician, yes.

Michael Rossi: The oncologist is essentially removed from his or her patient's treatment journey at this time. Third, there is a limited number of administration sites capable of handling radiopharmaceuticals. Right now, we need specialized diagnostic suites in order to be able to administer the radiopharmaceutical therapy, and there are a limited number of these across the globe.

I apologize this essentially removed from his or her patients treatment journey at this time.

Michael Rossi: Third there's a limited number of administration sites capable of handling radiopharmaceuticals.

Michael Rossi: Now, we need specialized agnostic suites in order to be able to administer the radiopharmaceutical therapy.

Michael Rossi: There are a limited number of these across the globe.

Michael Rossi: And fourth, continued drug shortages are an issue as current demand for radiopharmaceuticals increases. As manufacturers work to build the infrastructure I just referred to, drug shortages have become a reality, and patient care is delayed. Our goal with Thought Upgrade is to solve all of these challenges and provide a simpler and more efficient solution for physicians that will have a greatly improved impact on patient care. We are leveraging the existing infrastructure within infusion centers, oncologist offices, freestanding infusion centers, and outpatient centers. We administer SADA print in a two-step process. First, the patient can receive the non-radioactive soda in the existing center. Then, for the second step, the isotope infusion can be delivered at a nuclear medicine department or licensed imaging center. Because we're leveraging the existing infrastructure, we're increasing physician participation, and we're able to have more engagement with oncologists, specialists, and nuclear medicine physicians, which we believe will lead to better overall results. Importantly, SADAPRIC can be isotope agnostic.

Michael Rossi: And Ford continued drug shortages are an issue as current demand is increasing for radiopharmaceuticals.

Michael Rossi: [noise] manufacturers work to build the infrastructure I, just referred to drug shortages have become a reality and patient care is delayed.

Michael Rossi: Our goal with sort of credits to solve all of these challenges provide a simpler and more efficient solution for physicians that will have a greatly improved impact on patient care.

Michael Rossi: We are leveraging the existing infrastructure within infusion centers oncologists officers freestanding infusion centers and outpatient centers.

Michael Rossi: We administer sada pregnant two step process first the patient can receive the non radioactive side at existing centers and for the second step you used to talk infusion can be delivered at a nuclear medicine department or licensed imaging centers.

Michael Rossi: Because we are leveraging the existing infrastructure, we're increasing physician participation and we were able to have more engagement with oncologist specialists and nuclear medicine physicians, which we believe will lead to better overall results.

Michael Rossi: And importantly, <unk> can be used to totally agnostic.

Michael Rossi: As long as we can create linkers between the isotope and the SADA target that is already painted on the tumor, we will have the ability to utilize a multitude of diagnostic and therapeutic isotopes. As we look at these differentiators, around infrastructure and manufacturing, administration, and the ability to choose different isotopes in real time, as well as decrease toxicity levels to patients while increasing the targeted activity to tumors. We're very excited about the potential of Sodaprint to improve patient experience and expand the radiopharmaceutical treatment landscape.

Michael Rossi: As long as we can create lingers between the isotope and Masada target that has already seen it on the tumor we will have the ability.

Michael Rossi: To utilize a multitude of diagnostic and therapeutic isotopes.

Michael Rossi: As we look at these differentiators.

Michael Rossi: Iraq is a structure and manufacturing administration and the ability to choose different isotopes in real time as well.

Michael Rossi: Long as decreased toxicity levels to patient, while increasing the targeted activity to tumors. We're very excited about the potential upside of perpetual crude patient experience that expand radiopharmaceutical treatment landscape.

Michael Rossi: Now, let's turn to a brief update on our lead programs.

Michael Rossi: Now, let's turn to a brief update on our LEAP program, our Phase 1, GD2 SADA. As a reminder, our Phase 1 trial evaluating the safety and tolerability of GD2-SADA and the treatment of GD2-positive solid tumors, including small cell lung cancer, sarcomas, and malignant melanoma, got underway in March 2023. This phase 1 dose escalation single arm multi-center safety study has three parts. PARDE explores dose finding for the GD2-SATA molecule and the testing of dose intervals of two to five days between the protein and the Lutetium-177 DOTA payload.

Michael Rossi: Our phase one G D two saada.

As a reminder, our phase one trial evaluating the safety and Tolerability of G. D to start it in the treatment of G. D. Two positive solid tumors.

Michael Rossi: <unk> small cell lung cancer sarcoma is a malignant melanoma got underway in March of 2023.

Michael Rossi: This phase one dose escalation single arm Multicenter safety study has three parts.

Michael Rossi: Are they explores dose finding for JD to sort out the molecule and the testing and dose intervals of two to five days between the protein.

Michael Rossi: The lutetium 177 Delta payload.

Michael Rossi: Heartbeat determined the optimal dose of lutetium 177 data.

Michael Rossi: Part B determines the optimal dose of Lutetium-177, and Part C evaluates the safety and initial signs of efficacy using repeat dosing. Dose escalation is based on two patients in cohort 1 and 2, followed by a modified 3 plus 3 dose. It is important to emphasize that in each cohort, patients will be observed after dosing for a so-called six-week dose-limiting toxicity, or DLT, period. We are currently in Part A and are very pleased with how the trial has progressed. We have advanced through Cohorts 1, 2, and 3 and are now dosing patients in Cohort 4. We have dosed a total of 10 patients today. We currently have six active sites and plan to continue adding additional sites.

Michael Rossi: The party evaluates the safety and initial signs of efficacy using repeat dosing.

Michael Rossi: Dose escalation is based on two patients in cohort one and two followed by a modified three plus three design. It is important to emphasize that in each cohort patients will be observed after dosing and so called six week dose limiting toxicity or DLT period.

Michael Rossi: We are currently in part a and are very pleased with how the trial is progressing.

Michael Rossi: We have advanced through cohorts, one two and three and are now dosing patients in cohort four.

Michael Rossi: We have dosed a total of 10 patients to date.

Michael Rossi: We currently have six active sites and plan to continue adding additional sites.

Michael Rossi: Recall that part of the trials investigating the safety profile of the protein and determining the optimal time to deliver the radionuclide.

Michael Rossi: Recall that part A of the trial is investigating the safety profile of the protein and determining the optimal time to deliver the radionuclide. We are very encouraged by what we have seen so far. To date, no patients have experienced any dose-limiting toxicity.

Michael Rossi: We are very very encouraged.

Michael Rossi: By what we've seen so far to date no patients have experienced any dose limiting toxicities.

Michael Rossi: Based on the spec C T scans PK activity, we have seen to date.

Michael Rossi: Based on SPECT CT scans and PK activity we have seen to date, we believe that we have demonstrated proof of concept, namely that GD2-SATA can both find and bind to tumors. However, it is important to note that these early data are not complete and are not necessarily indicative of a full result or the ultimate success of the trials or the SADA development program. We expect to share data from Part A of this Phase I study at a medical meeting in the second half of this year. Our second SADA program is CD38 SADA, which we'll participate in..., which we plan to first study in patients with non-Hodgkin's lymphoma, focusing on B and T cell lymphoma. This is our first SADA program to be studied in blood.

Michael Rossi: We believe that we have demonstrated proof of concept, namely that G. D. Toussaud I can find them buying to tumors. It is important to note that this early data are not complete and are not necessarily indicative of a full results or the ultimate successful trials or the Sada development program.

Michael Rossi: We expect to share data from part a of this phase one study at a medical meeting in the second half of this year.

Michael Rossi: Yeah.

Michael Rossi: Our second SATA credit program at CD 38 Saada.

Michael Rossi: Which we were playing.

Michael Rossi: Which we play in the first study in patients with non Hodgkin's lymphoma, focusing M B and T cell lymphoma.

Michael Rossi: This is our first sort of program to be studied in blood cancer.

Michael Rossi: Our IND has been approved by the FDA, and as you can see here, our planned phase one follows a comparable design to our GD2-SATA probe. We are on track to enroll two sites in April and expect to dose the first patients in this phase one trial this year. We believe the potential of the radiopharmaceutical industry is at a huge inflection point and piqueing the interest of physicians and patients alike. We truly believe that SADA's novel and differentiated approach has the potential to become the targeted radiopharmaceutical delivery platform of choice for the treatment of multiple solid tumors and blood cancer. I will now pass the call over to Sue Smith to provide further color on U.S. Daniels sales for the fourth quarter and full year 2020.

Michael Rossi: Alright, and D has been approved by the FDA and as you can see here our planned phase one follows a comparable designed toward G. D to start a program.

Michael Rossi: We are on track to enroll two sites in April and expect to dose. The first patients in this phase one trial this year.

We believe the potential of the radiopharmaceutical industry is at a huge inflection point and piquing the interest of physicians and patients alike.

Michael Rossi: We truly believe that Sottish novel and differentiated approach has the potential to become the targeted radiopharmaceutical deliberate path platform choice in the treatment of multiple solid tumors and blood cancers.

Michael Rossi: I will now pass the call over to Sue Smith to provide further color on U S. Daniels of sales for the fourth quarter and full year 2023.

Michael Rossi: Sure.

Sue Smith: Thank you, Mike, and good morning, everybody. Before I discuss some of the key highlights from Danielle's AUS sales in the fourth quarter, let me provide a brief review of the enhanced marketing efforts our commercial team launched throughout the fourth quarter of last year. We have successfully rolled out a new Danielza campaign aimed to reposition and elaborate on Danielza's differentiating characteristics in the treatment of neuroblastoma for patients who have experienced an incomplete response to induction therapy in their bone and bone marrow. Utilizing our pivotal study data, consistent with our label, the new campaign enables us to share our data for refractory versus relapsed patients separately, providing more detailed data In addition, the new campaign demonstrates Danielza's response in children after prior anti-GD2 therapy.

Sue Smith: Thank you, Mike and good morning, everybody.

Sue Smith: Before I discuss some of the key highlights from Daniels of U S sales in the fourth quarter. Let me provide a brief review of the enhanced marketing efforts, our commercial team launched throughout the fourth quarter of last year.

Sue Smith: We have successfully rolled out our new Daniels the campaign aimed to reposition and elaborate on Daniels is differentiating characteristics and the treatment of neuroblastoma patients who have experienced incomplete response to induction therapy and they've done in bone marrow.

Sue Smith: Utilizing our pivotal study data consistent with our label the new campaign enables us to share our data for refractory versus relapsed patients separately, providing more detailed data regarding daniels's performance in two different patient populations those patients with an incomplete response to induction therapy.

Also in addition to patients who are relapsed.

Sue Smith: In addition, the new campaign demonstrates daniels's response in children. After prior anti G D to therapy well.

Sue Smith: While we continue to expect meaningful traction from the new campaign over the coming quarters, I am really pleased with the positive initial feedback in the form of commercial progress for Danielza in the U.S. that we saw in just the fourth quarter. In the fourth quarter of 2023, we increased Danielle's net product revenues by 42% year-over-year to $23.4 million compared to the fourth quarter of 2022. That is a 17% increase compared to the third quarter of 2023. We continue to see an upward trend of sales growth since the initial launch back in 2021, and we believe we have room for continued growth. As Mike mentioned, we recorded $84.3 million in Danielza Net Product Revenues for the full year 2023, achieving the high end of our updated Net Product Revenue Guidance range of between $80 million and $85 million. A total of 58 accounts have now used Danielza around the U.S. since its initial launch in 2021, with 10 new accounts added in 2023.

Sue Smith: We continue to expect meaningful traction from the new campaign over the coming quarters.

Sue Smith: I'm really pleased with the positive initial feedback in the form of commercial progress of Daniel's that in the U S that we saw in just the fourth quarter.

Sue Smith: [noise] excuse me for the fourth quarter of 2023, the increased Daniels in net product revenues by 42% year over year to $23 4 million compared to the fourth quarter of 2022.

That is a 17% increase compared to the third quarter of 2023.

Sue Smith: We continue to see an upward trend of sales growth since the initial launch back in 2021, and we believe we have room for continued growth.

Sue Smith: As Mike mentioned, we recorded $84 3 million in Daniels, our net product revenues for the full year 2023, achieving the high end of our updated net product revenue guidance range of between 80 million $85 million.

Sue Smith: A total of 58 accounts have now used daniels or around the U S census initial launch in 2021 with 10, new accounts added in 2023.

Sue Smith: We believe physicians are getting more comfortable using Daniels with 41, H C piece, having prescribed Daniels that in 2023, including eight E. C piece, starting two or more patients in here.

Sue Smith: We believe physicians are getting more comfortable using Danielza, with 41 HCPs having prescribed Danielza in 2023, including eight HCPs starting two or more patients in the year. Since launch, a total of 93 healthcare practitioners have prescribed Danielza, and 28 HCPs have started treatment in two or more patients as of December 31st, 2023. Our U.S. commercial sales team continues to receive positive HCP feedback on Danielza through ongoing customer interactions. In addition, we continue to see institutional adoption of Danielza, which has been added to six hospital formularies in 2023, bringing the total since launch to 42 hospital formularies as of December 31st, 2023. Danielza remains a leading therapy in the U.S. anti-GD2 market, a highly important area of pediatric cancer in a rare disease market. Our team remains steadfastly focused on further market penetration across high-volume centers to reach more patients and improve outcomes. Let me now pass the call to Vignesh. Thank you, Sue. And hello everyone.

Sue Smith: Since launch a total of 93 health care practitioners have prescribed Daniel Zhang and 'twenty E. E. G. P. S have started treatment in two or more patients as of December 31st 2023.

Sue Smith: Our U S. Commercial sales team continues to receive positive H C. P feedback on Daniel Zhang to ongoing customer interactions and.

Sue Smith: In addition, we continue to see institutional adoption of Daniel's that which has been added to six hospital formularies in 2023, bringing the total since launch to 42 hospital formularies as of December 31 2023.

Sue Smith: Daniels remains a leading therapy in the U S. Anti G D to market a highly important area on pediatric cancer in a rare disease market.

Sue Smith: Remains steadfastly focused on further market penetration across high volume centers to reach more patients and improve outcomes.

be cash: Let me now pass the call to be cash.

Cash: Thank you Sue and Hello, everyone I'm pleased to provide a brief update on our ongoing next to them a clinical trials.

Vignesh Rajah: I'm pleased to provide a brief update on our ongoing Nexidema clinical trial. We continue to advance potential label expansion opportunities for Danielza through our investigator-sponsored clinical studies in collaboration with leading KOLs. In the frontline high-risk neuroblastoma setting, we have partnered with BEAT Childhood Cancer Research Consortium or BCC in a multi-center phase 2 trial evaluating maxidermab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma.

We continue to advance potential label expansion opportunities for Daniels that through our investigator sponsored clinical studies in collaboration with leading Kols.

Cash: And the frontline high risk neuroblastoma, setting we have partnered with beach childhood cancer Research consortium or BCC in a multi center phase two trial evaluating <unk> in combination with standard induction therapy for patients with newly diagnosed harvest neuroblastoma.

Cash: As of February the 12th 'twenty, 'twenty 413 sites have been initiated and seven patients have been dosed.

Vignesh Rajah: As of February 12, 2024, 13 sites have been initiated, and 7 patients have been dosed. The study is expected to transition from a single-arm study, i.e., with exudamab added to the current standard treatment for induction, to a randomized study where the control arm will be the current standard of care for induction therapy, which is chemotherapy plus or minus alkene inhibitors.

Cash: The study is expected to transition from a single arm study with an exit amount added to current standards frequent of induction.

Cash: Randomized study with a control arm will be the current standard of care for induction therapy, which is chemotherapy plus or minus alpha inhibitor.

Vignesh Rajah: Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy with anoxetamolam versus standard of care. We expect to potentially initiate the new randomized study in the second quarter of this year. In osteosarcoma, we are continuing to work with Memorial Sloan-Kettering on its multi-centered investigator-sponsored trial of Exudomab. We continue to expect MSK to provide data readout from this Phase 1-2 trial in the fourth quarter of this year. And based on the outcome of this, we will evaluate plans for our randomized trial to be initiated in the second quarter of 2025. In breast cancer, we have partnered with The Ohio State University on a Phase 1b-2 trial investigating TGF-beta NK cells and gemcitabine plus nixidamide in patients with GD2-positive metastatic breast cancer.

Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy and the next suite of mom connected my mom versus standard of care.

Cash: We expect to potentially initiate the new randomized study in the second quarter of this year.

Cash: In Austria sarcoma, we are continuing to work with memorial Sloan Kettering on its multi centered investigator sponsored trials and they set them up with.

Cash: We continue to expect <unk> to provide basic read out from this phase one two trial in the fourth quarter of this year and based on the outcome of this we will evaluate plans for a randomized trial to be initiated in the second quarter of 2025.

Cash: In breast cancer, we have partnered with the Ohio State University and a phase one b slash two trial investigating TGF beta NK cells, Jim side have been talking to sit them out in patients with <unk> positive metastatic breast cancer.

Cash: The first patient is expected to be dose at meals that in the first half of this year.

Vignesh Rajah: The first patient is expected to be dosed with Danielza in the first half of this year. Upon the outcome of this trial, we would consider moving forward with a multi-center Phase 2 trial. We continue to advance our strategy aimed at unlocking the full potential value of mexidermab for patients beyond those impacted by a relapsed or refractory high-risk neuroblastoma. We believe there still remains significant potential in the anti-GD2 space in both pediatric and adult cancer.

Cash: The outcome of this trial, we would consider moving forward with a multicenter phase III trial.

Cash: We continue to advance our strategy aimed at unlocking the full potential value makes it applications beyond those impacted by relapsed or refractory harvested neurovascular.

Cash: We believe there still remains significant potential can be anti gd to space in both pediatric and adult cancers. We look forward to updating you on our progress.

Bo Kruse: We look forward to updating you on our program. Let me now hand over the call to Bo Kruse. Thank you. Thank you, Vignesh, and good morning, everyone. Danielle's net product revenues of $84.3 million for the year ended December 31st, 2023, represented an increase of 71% from the $49.3 million reported for the year ended December 31st, 2022. The increase of $35 million was primarily driven by an increase in new U.S. patients and an incremental benefit from expanding international revenue. Our global Danielsa Net Product revenues of $23.4 million for the fourth quarter of 2023 represented a 42% increase compared to the fourth quarter of 2022 and a favorable 17% increase compared to the third quarter of 2023, as we saw increases from U.S. revenues as well as from international revenues.

Speaker Change: Now I hand over the call to brokerage.

Speaker Change: Okay.

Brokerage: Thank you with weakness and good morning, everyone.

10 years of net product revenues of $84 3 million for the year ended December 31st 2023, representing an increase of 71% to $49 3 million reported for the year and it did.

Brokerage: Sympathetic face 'twenty to 'twenty two.

Brokerage: The increase of 35 million was primarily driven by an increase in U U S patients at an incremental benefit from expanding international revenues.

Brokerage: Our global Daniels amid product revenues of $23 4 million for the fourth quarter 2023, representing 42% increase compared to the fourth quarter of 2022 and a favorable 17% increase compared to the third quarter 2020 free as we saw increases.

Brokerage: From U S revenues as well as from international revenues.

Brokerage: U S revenues increased 19% to $19 1 million in the fourth quarter compared to $16 1 billion in the third quarter of 2020 and international revenues increased 11% to $4 3 million in the fourth quarter compared to $3 9 billion in the third quarter.

Bo Kruse: U.S. revenues increased 19% to $19.1 million in the fourth quarter, compared to $16.1 million in the third quarter of 2023, and international revenues increased 11% to $4.3 million in the fourth quarter, compared to $3.9 million in the third quarter. We reported $15 million worth of license revenue in the three months into December 31st, 2022 and didn't have any license revenue for the three months into December 31st, 2023.

Brokerage: We reported 15 million daus waste of license revenue in the three months ended December 31st 2022, and didn't have license revenue for the three months ended December 31st 2020 free.

Brokerage: Moving to operating expenses.

Bo Kruse: Moving to operating expenses, our research and development expenses decreased by $6.4 million and $37.4 million to $13.4 million and $54.2 million for the three months and year ended December 31, 2023, respectively, compared to the same periods in 2022. The net decrease was primarily due to the decrease in spending on deprioritized programs in connection with our restructuring plan announced in January 2023, which resulted in decreases in outsourced manufacturing, outsourced research and supplies, clinical trials, and personnel-related costs. The decrease was partially offset by a $4.1 million accrual of time-based clinical milestones related to our start-up technology. Selling general and administrative expenses decreased by $0.3 million and $16.1 million, so $11.1 million and $44.9 million for the three months and year ended December 31, 2023, respectively, compared to the same period since 2012.

Brokerage: Our research and development expenses decreased by $6 4 million and $37 4 million.

Brokerage: The $18 4 million and $54 2 million for the three month.

Brokerage: And year ended December 31st 2023, respectively compared to the same periods of 'twenty to 'twenty two.

Brokerage: The net decrease was primarily due to the decreased spending on D prototypes programs in connection with our restructuring plan announced in January 2020, free which was solid and decreases in outsourced manufacturing.

Brokerage: So its research and supplies clinical trials and personnel related costs. The decrease was partially offset by a full point of $1 billion of cool San based clinical milestones related to our technology.

Selling general and administrative expenses decreased by <unk> 3 million and $16 1 billion. So $11 1 million and 44 9 million for the three months and year ended December 31st 2023, respectively compared to the same periods in 'twenty two.

Bo Kruse: The decrease in STNA for the year ended December 31, 2023 was primarily attributable to a $10.9 million charge related to the departure of our former chief executive officer in Q2 2022, and to a lesser extent, a $3.4 million decrease in commercialization expenses compared to expenses incurred in 2022 in anticipation of a potential convertible plant. We reported a net loss for the quarter ended December 31st, 2023, of just 1 million or 2 cents per share, basic and diluted, compared to net income of 1.2 million or 3 cents per share, basic and diluted, for the quarter ended December 31st, 2022, which included a regulatory-based milestone of $15 million from Cyclone Pharmaceuticals for the conditional approval of Daniosa in China in 20 Additionally, we reported a net loss for the year ended December 31st, 2023 of $21.4 million, or 49 cents per share, basic and diluted, compared to a net loss of $95.6 million, or $2.19 per share, basic and diluted, for the year ended December 31st, 2022.

Brokerage: The decrease in SG&A for the year ended December 31st 2003 was primarily attributable to a $10 9 million charge related to the departure of our former Chief Executive Officer in Q2, 2022 and certainly they extend at $3 4 million dollar decrease in commercialization.

Brokerage: Sensors compared to expenses incurred in 'twenty, two and anticipation of a potential brought them at launch.

Brokerage: We reported net loss for the quarter ended December 31st 2020 feet of just $1 million.

Brokerage: <unk> per share basic and diluted compared to net income of $1 2 million or three cents per share basic and diluted for the quarter ended December 31st 2022 which included and regulatory based milestone of $15 million from cyclone pharmaceuticals for the conditional approval stimulus in China.

Brokerage: In 2022.

Brokerage: Additionally, we reported a net loss for the year ended December 31st 2020 feet of $21 4 million or 49 cents per share basic and diluted compared to a net loss of $95 6 million or $2 19 per share basic and diluted for the year ended December 31st 22.

Brokerage: True.

Brokerage: The decrease in net loss was primarily driven by higher product revenues lower R&D expenses lower SG&A expenses inclusive of the 10 9 million the decrease for the charges related to the departure.

Bo Kruse: The decrease in net loss was primarily driven by higher product revenues, lower R&D expenses, and lower SG&A expenses, inclusive of the $10.9 million decrease for the charge related to the departure of the company's former CEO in Q2 2022. As mentioned earlier, we ended the fourth quarter 2023 with cash and cash equivalents of $78.6 million compared to $105.8 million at year-end 2022. The decrease was $27.1 billion for the

Brokerage: The company's former CEO in Q2, 2022.

Brokerage: As mentioned earlier, we ended the fourth quarter 'twenty, three with cash and cash equivalents of $78 6 billion compared to $105 8 million at year end 2022.

Brokerage: The decrease was $27 1 billion put it for you.

Bo Kruse: Importantly, we reduced our annual cash use by $75.8 billion to $27.1 million, about 64% in 23 compared to 2020. Now, let me turn to our financial guidance for the full year 2024. We expect full-year 2024 Danielsa Net Product Revenues to be in the range of $95 to $100 million. Based on the midpoint of the guidance, this corresponds to an increase of approximately 16% compared to 2023. We anticipate operating expenses to be in the range of $115 to $120 million, reflecting a midpoint increase of approximately 6% compared to 2023. And in total, the expected cash burn for the full year 2024 to range from 15 to 20 million, and the midpoint decrease of approximately 35% from 2023.

Brokerage: Importantly, we reduced our annual cash used from $75 8 billion to $27 1 billion or about 64% 23 compared to 2022.

Speaker Change: Now let me turn to talk my name is guidance for the four year plan.

Speaker Change: 24.

We expect full year 'twenty 'twenty four the neilson net revenues to be in the range of $95 million to $100 million based on the midpoint of the guidance. This corresponds to an increase of approximately 16% compared to 2020 three.

Speaker Change: We anticipate operating expenses to be in the range from $115 million to $120 million, reflecting a midpoint increase of approximately 6% compared to 2023.

Speaker Change: And total expected cash burn for the full year 2020 fall to range from 15 to 20 million midpoint decrease of approximately 35% from 2023.

Bo Kruse: But we continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently planned into 2027. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. For the purpose of this specific analysis of our cash runway only, the Danielta Net Product Revenues are assumed to increase by 10 percent each year from $24 through 2027.

Speaker Change: Continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently claims plant into 'twenty 'twenty seven.

Speaker Change: As we noted in previous quarters, the underlying assumptions for this guidance and poised to understand for the purpose of this specific analysis of all cash Rumbly only but then yesterday net product revenues I assume to increase by 10% each year.

Speaker Change: When he saw through 2027, and we hope to see a higher gross wasteful Danielle.

Bo Kruse: We hope to see a higher growth rate for Danielta as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater decision adoption. In terms of development activities, we have assumed that our prioritized programs will be advanced at our own expense, and no new programs other than our planned studies and trials are assumed at this point for purposes of the analysis. We believe Y-mAbs is strongly positioned to execute on our strategic mission and our priorities and to support the delivery of multiple milestones. This concludes the financial update, and I'll now turn the call back to Mike. Thank you for that overview, Bo. Let's now open the line for questions. Operator.

Speaker Change: Execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater physician adoption.

Speaker Change: In terms of development activities, we have assumed that our prioritized programs will be advanced at our own expense and no new programs other than our planned studies and trials I assume at this point for purposes of the analysis.

We believe Wimax is strongly positioned to execute on our strategic mission and our priorities and to support the delivery of multiple milestones.

Speaker Change: This concludes the financial update and I'll now turn the call back to Mike.

Michael Rossi: Thank you for that overview boat.

Michael Rossi: Let's now open the line for questions.

Michael Rossi: Operator.

Speaker Change: Thank you 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 another question Kim.

Operator: Thank you. At this time, we'll be conducting a question-and-answer session. If you'd 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.

Operator: You may press Star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing Star. We ask that you each keep to one question and one follow-up and invite you to re-join the queue. Our first question comes from the line of Alec Stranahan with Bank of America. Please proceed with your question. Hey, guys. Thanks for taking our questions. Just a couple from us.

Speaker Change: You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

Speaker Change: We ask that you each keep to one question and one follow up and invite you to rejoin the queue.

Speaker Change: Our first question comes from the line of Alec Stranahan with Bank of America. Please proceed with your question.

Alec Warren Stranahan: Hey, guys. Thanks for taking our questions I'm, just just a couple from us.

Michael Rossi: First, on Danielza, what kind of ex-U.S. contribution to the top line should we be expecting in 2024? And, I guess, what percent of the full-year guidance does that represent? And then one on the SADA update later this year.

Alec Warren Stranahan: First on Daniels, what kind of ex U S contribution to the top line should we be expecting in 2024, and I guess what percent of the full year guidance does that represent and then one on disorder update later this year I guess could you maybe help frame the part.

Michael Rossi: I guess, could you maybe help frame the Part A data we should expect in the second half? Do you think we'll get a good idea of the dosing schedule and or tumor localization in the update? Or will the focus really be more on safety, since this is the first in human study? Thanks. Hey, Alec.

Alec Warren Stranahan: <unk> data, we should expect in the second half do you think we'll get a good idea of dosing schedule and or tumor localization to update or will the focus really be more on safety. Since this is the first in human study.

Alec Warren Stranahan: Alex. Thank you much appreciate it I'll start with the second question first on the startup they decided to update.

Michael Rossi: Thank you. It is much appreciated. I'll start with the second question first on the SADA update. It is going to be focused on part A of that phase one trial, and it is really designed to be a safety study. So the two areas that we're looking to solidify as part of that are what the dose will be from the SADA protein load and what the dosing interval will be between the protein administration and the lutetium payload. So those are really the two points that we're looking for.

Alex: He is going to be focused on part a of that phase one trial and it is really designed to be a safety study.

Alex: The two areas that we're looking to solidify as part of that is what.

Alex: Most will be from the sada protein load.

Alex: And what the dosing interval, we'll be between the protein administration and the lutetium payload.

Alex: So they're really the two points that we're looking for and again. This is a pure safety studies. So we're not expecting to see efficacy signals from that first part.

Michael Rossi: And again, this is a pure safety study, so we're not expecting to see efficacy signals from that first part, but we will provide some dosimetry and some visual images as well as part of that. So the first part of your question about the XUSL, I'll pass that off to Bo, and Bo can give you a little bit more color on the division between the US and the XUSL.

Alex: But we will provide some dose of maturity and some visual images as well as part of that.

Alex: So the first part of your question talking about the ex U S sales I'll pass it off to bowl and both could give you a little bit more color on the the division between the U S and the extra itself.

Bowl: Yeah sure. Thank you Mike.

Bo Kruse: Yeah, sure. Thank you, Mike. So, as you already noted, the fourth quarter's bid was so that U.S. sales were about 82 percent of the total product sales, and for the full year, the U.S. accounted for about 80 percent.

So as you already noted the fourth quarter spend was so that the U S sales were about 82% of the total product sales and for the full years U S counted for about 80% so in terms of.

Bo Kruse: Budgeting and guidance. We've been quite conservative on the international contribution, reduced about five to eight basis points compared to what we saw in 2023, just to be concise. Great, thank you. Thank you. Our next question comes from the line of David Nierengarten with Wedbush Securities. Please proceed with your question.

Speaker Change: Getting in guidance, we've been quite conservative on the <unk>.

Speaker Change: International contribution so so.

Speaker Change: <unk>.

Speaker Change: Reduced about five to eight basis points compared to what.

Speaker Change: What we saw in 2023 just to be conservative.

Speaker Change: Great. Thank you.

Speaker Change: Yeah.

Speaker Change: Thank you. Our next question comes from the line of David nearing gotten with Wedbush Securities. Please proceed with your question.

David Matthew Nierengarten: Hey, Thanks for taking the question maybe maybe this is a question too far ahead to think about but I was curious about and your ability to use different isotopes with asada platform and if there were any plans to compare.

Michael Rossi: Hey, thanks for taking the time to ask me a question. Maybe, maybe this is a question too far ahead to think about, but I was, I'm curious about your ability to use different isotopes with the SADA platform and if there were any plans to compare the safety and efficacy of different isotopes with the same, you know, target, the same patient population. So, I don't know if you have that answer, but that's my question.

David Matthew Nierengarten: Safety and efficacy of different isotopes with the same you know with the same target the same patient population.

Speaker Change: So I don't know if you have that answer but that's my question.

Michael Rossi: So, David and I appreciate it, and it's never too early to start thinking about that or moving forward. Now, one of the challenges that I spoke to is the ability to, you know, have flexibility in manufacturing. So when you look at the way these products are constructed, when you're doing a pre-tagged conjugate, you're very limited in what you can do when you can do it.

Speaker Change: Well, David I appreciate it and it's never too early to start thinking about that or moving forward.

Speaker Change: Now one of the challenges that I spoke to is the ability to.

Speaker Change: You have flexibility in manufacturing so when you look at the way these products.

Speaker Change: Products are constructed when youre doing a pre tagged conjugate.

Speaker Change: Got you got you.

Speaker Change: You're very limited on what you can do when you can do it halfway determines a lot of that so it's really challenging for some.

Michael Rossi: Half-life determines a lot of that, so it's really challenging for some. Some organizations move forward, but for us,

Speaker Change: Some organizations moot board for us.

Michael Rossi: Taking the isotope agnostic approach, since we don't need a manufacturing facility to put the drug and the isotope together prior to injection, the patient actually becomes that production facility. So that infrastructure is no longer needed. What that allows us to do then is to design the cages around those isotopes to link back to the SADA platform, which won't change. So our GD2 SADA construct that we go forward with will be the final drug product for that. The next part is right now we're using go to cage lutetium, but as you move forward and investigate other isotopes such as lead, xenium, even getting into the coppers or fluorines, and galliums. It gives us the opportunity to then mix and match, and you know, comparisons will be inevitable, which is a good thing. But, you know, for some of these things like lutetium, there's a pretty good safety and track record on that already.

Speaker Change: Taking the isotope agnostic approach since we don't need a manufacturing facility to put the drug in the I used to talk together.

Speaker Change: Prior to injection the patient the patient actually becomes that that production facility. So that infrastructure is no longer need it what that allows us to do then is to design the cages around those isotopes.

Speaker Change: Two late back to the Sada platform.

Which won't change so are our G D. Two sada construct.

Speaker Change: That we go forward with will be the final drug product come outside.

The next part is right now we're using a dota cage the TCM as you move forward and investigate other isotopes such as led actinium, even getting into the coppers.

Or flooring is galleons.

Speaker Change: It gives us the opportunity to mix and match and comparisons will be inevitable and which is a good thing.

Speaker Change: But you know for some of these things like lutetium.

Speaker Change: There was a pretty good safety track record on that already as we start looking at some of the other isotopes, we'll be learning more as an overall industry as other drug studies come forward to I don't know.

Michael Rossi: As we start looking at some of the other isotopes, we'll be learning more as an industry as other drug studies come forward, too, on what these isotopes look like. But approaching it from the fact that, you know, we're not limited to putting these together outside of the patient. When it happens in the patient, we have more ability to go forward and allow physicians then to select the isotopes that they choose to use as we progress in our clinical studies. We'll obviously need to study each of the isotopes in conjunction with our protein molecule and determine the safety and efficacy of those as we go, but long-term, it expands the opportunity for physicians to treat individual patients. I appreciate it, Dave.

Speaker Change: I used to talk to look like.

Speaker Change: So but approaching it from the fact that.

Speaker Change: We're not limited to putting these together outside of the patient that had happened to the patient we have more ability to go forward and well positioned for them to select the isotopes.

Speaker Change: That they choose to use them as we progress in our clinical studies will obviously need to study each of the isotopes in conjunction with our protein molecule.

Speaker Change: And determined that the safety and efficacy of those as we go but long term it expands the opportunity for physicians to treat individual patients.

Speaker Change: Thanks.

Speaker Change: Okay.

Speaker Change: I appreciate it.

Speaker Change: Thank you once again as a reminder, please press star one to join the question queue. Our next question comes from the line of <unk> with BMO capital markets. Please proceed with your question.

Michael Rossi: Thank you. Once again, as a reminder, please press star 1 to join the question queue. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Please proceed with your question. Hi, Luke Shumway on behalf of ETSER.

Speaker Change: Hi, Luke somebody I'm sure answer thanks for taking my question can I ask about your thoughts around the C 30 seats on our program.

Michael Rossi: Thanks for taking my question. Can I ask about your thoughts around the CD38 SADA program? That landscape is obviously evolving with Jen Mapp and J&J kind of having a death grip on Darzalex.

Speaker Change: Landscape is obviously, you've all dealing with.

Luke: Genmab and J&J kind of having a death grip with legs.

Michael Rossi: What gives you confidence in the SADA approach to targeting CD38? Yeah, that's, I appreciate it. It's a very good question.

Luke: What kind of gives you confidence in.

Luke: This sort of approach and targeting CD 38.

Speaker Change: Yeah that's.

Speaker Change: I appreciate it it's very good question.

Michael Rossi: You know, we've selected two targets to start. One is GD2, since we have a tremendous amount of experience with Danielza and the GD2 platform. The second component is a lot of in-house domain knowledge associated with CD38. The second component is looking at the overall ability to treat solid tumors as well as circulating tumors with systemic radiotherapy. We know, historically, Hodgkin's lymphoma is very radio-sensitive. We've seen this with some early drugs, and so moving into the ability to use CD38 with systemic radiotherapy is very intriguing for us in order to give those patients another alternative, potentially something that would be complementary to existing treatments in the market, as well as giving patients alternatives to potential therapies they don't want. So it's always interesting as you enter into crowded markets. But that being said,

Speaker Change: We've selected two targets to start one of G. D. Two since we have a tremendous amount of experience with Daniels.

Speaker Change: And the G. D. Two platform. The second component is a lot of in house domain knowledge associated with CD 38.

Speaker Change: The second component is just looking at the overall ability to treat solid tumors as well as circulating tumors.

Speaker Change: With systemic radiotherapy, we know.

Speaker Change: Historically.

Speaker Change: Non Hodgkin's lymphoma is very radio sensitive we've seen this with some early drugs.

Speaker Change: Early trials, so moving into.

Speaker Change: The ability to use a CD 38 with systemic radiotherapy is very intriguing for us.

Speaker Change: In order to give those patients a another alternative.

Speaker Change: Potentially.

Speaker Change: That would be.

Speaker Change: Complementary to existing.

Speaker Change: Treatments in the market as well as giving giving patients alternative to potential therapies. They don't want to use so it's always interesting as you enter into crowded markets, but that being said.

Michael Rossi: We know, as we start targeting some of these radio-sensitive tumors. We don't want to shy away from an area just because there is competition. Competition is good in the ability to give patients and physicians choices on treatment. It's something that is a cornerstone in the pharmaceutical market. Okay, and then if I could, one more question, for the GD2 SADA Part A, what is your measure of success? Like, what's your go-go-go that you're looking for?

Speaker Change: We know actually start targeting targeting somebody treaty of sensitive tumors.

Speaker Change: The we don't want to shy away from an area.

Speaker Change: Just because there is competition competition is good and the ability to give patients and physicians choices on treatment.

Speaker Change: Something that.

Speaker Change: Cornerstone in it.

Speaker Change: Okay.

Okay, and then if I could one more for the G. D. Tucson apart what's what is your measure for success. It's like once you go don't go that you're looking for.

Speaker Change: Well for US I think it's a it's a safety study right. So we havent had any dose limiting toxicity to date so for us, it's making sure that we continue to.

Michael Rossi: Well, for us, I mean, it's a safety study, right? So, we haven't had any dose-limiting toxicities to date. So, for us, it's making sure that we continue to see a safe drug that could potentially be efficacious and that we're also seeing the tumors continue to shrink. And being a basket trial, we're also, you know, this isn't a situation where we just took a protein, injected it into healthy humans, and determined that it is safe on its own.

Speaker Change: C a safe drug that could potentially be efficacious and that we're also seeing continuing to paint the tumors and they get.

Speaker Change: A basket trial. We're also you know that.

Speaker Change: This isn't a situation, where we just hook up approaching injected into to help humans and and determined that it is safe on its own were also injecting the radioactivity with it which is giving us additional information.

Michael Rossi: We're also injecting the radioactivity with it, which is giving us additional information on tumor expression, tumor uptake, as well as what cancers may be more susceptible or have a better affinity for TD2-SATA. So, it's really information gathering, and it allows us to then remove some variables as we move into phase two. But we're very happy with how the safety trial is progressing. Okay, thanks so much. Thanks, folks. Thank you. Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Mr. Rossi for the final question. Very good.

Speaker Change: On tumor expression on tumor uptake as well as what what cancers may be more susceptible or more is a better affinity for G. D. Two sada. So it's it's really information collecting and it allows us to then remove some variables as we move into phase two but we're very happy with how the.

Speaker Change: The safety trials progressing.

Speaker Change: Okay. Thanks, so much.

Thanks, Mike.

Speaker Change: Thank you, ladies and gentlemen that concludes our question and answer session I'll turn the floor back to Mr. Rossi for final comments.

Michael Rossi: Very good I appreciate it. Thank you everybody for participating in today's fourth quarter and full year 2023 earnings call and for your continued interest in why Mad with a strong financial foundation and the right team in place you believe why mobs is positioned to continue.

Michael Rossi: I appreciate it. Thank you, everybody, for participating in today's fourth quarter and full year 2023 earnings call and for your continued interest in Y-mAb. With a strong financial foundation in the right place, we believe Y-mAbs is positioned to continue to improve.

Operator: We continue improving outcomes for patients and families impacted by childhood cancers while at the same time potentially shifting the treatment paradigm for a variety of both pediatric and adult cancers with our novel pre-targeted radio-immune therapy platform. We're very encouraged by the early data we've seen so far, and incredibly excited about the potential of SADAPRIT to emerge as the preferred radio-pharmaceutical treatment platform of choice for physicians and their patients. We look forward to providing further updates throughout the year and seeing many of you at upcoming conferences. Thank you and have a great day. Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

Michael Rossi: Continue improving outcomes for patients and families impacted by childhood cancers, while at the same time potentially shifting the treatment paradigm for a variety of both pediatric and adult cancers with our novel pre targeted radio immunotherapy platform.

Michael Rossi: We're very encouraged by the early data we've seen so far is incredibly excited about the potential upside of threat to emerge as the preferred radiopharmaceutical treatment platform of choice for physicians and their patients.

Michael Rossi: Forward to providing further updates throughout the year and seeing many of you at upcoming conferences. Thank.

Speaker Change: Thank you and have a great day.

Speaker Change: Thank you. This concludes today's conference call you may disconnect. Your lines at this time. Thank you for your participation.