Q4 2023 Y-mAbs Therapeutics Inc Earnings Call

In this article:

Participants

Courtney Dugan; VP, Head of IR; Y-mAbs Therapeutics Inc

Michael Rossi; President, Chief Executive Officer, Director; Y-mAbs Therapeutics Inc

Susan Smith; Senior Vice President, Chief Commercial Officer; Y-mAbs Therapeutics Inc

Vignesh Rajah; Senior Vice President, Chief Medical Officer; Y-mAbs Therapeutics Inc

Bo Kruse; CFO, EVP, Treasurer, & Secretary; Y-mAbs Therapeutics Inc

Alec Stranahan; Analyst; BofA Global Research

David Nierengarten; Analyst; Wedbush Securities Inc.

Lukas Shumway; Analyst; BMO Capital Markets

Presentation

Operator

Good morning and welcome to the Y-mAbs Therapeutics earnings conference call for the fourth quarter and full year of 2023. (Operator Instructions) As a reminder, today's conference will be recorded.
And I'll now turn the call over to Y-mAbs Head of Investor Relations, Courtney Dugan.

Courtney Dugan

Thank you, operator, and good morning, everyone. And welcome to the Y-mAbs Fourth Quarter and Full Year 2023 financial results conference call. We issued a press release with our results yesterday after market close and the press release and accompanying slides are available on the IR section of our website.
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.
Such statements include, but are not limited to, statements about our business model and development, commercialization and product distribution plans and expectations with respect to early trial data, current and future clinical and preclinical studies and our research and development programs, expectations related to the timing of initiation and completion of regulatory submissions for regulatory marketing and reimbursement approvals, including statements with respect to future development of other development programs, potential for DANYELZA territory and label expansion and potential of an advancement of finance collaborations are 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, guidance and expectations for 2024 and beyond and are financial performance, including our estimates regarding revenues, expenses and capital expenditure requirements 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 or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the Company's annual report on Form 10 K for the year ended December 31st, 2023, as filed with the SEC on February 29th, 2024.
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 us. I have with me today, our Chief Financial Officer, Bill Kraus, our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Dr. Vishal Shah, Thomas Gad, our Founder and Chief Business Officer, and Dr. seamlessly Leslie, 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 de novo sales, an update on our clinical program, utilizing our self assembly disassembly pre targeted radioimmunotherapy or sort of flip technology platform.
Next to we'll report further insights into our global DANYELZA sales in the fourth quarter. Finish will then provide updates on our ongoing asset unmet clinical trials, but 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 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 radioimmunotherapy platform site upgrade complemented by our commercial antibody therapy DANYELZAon driving 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 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, we believe we have sufficient financial resources to advance the clinical development of our scientific platform.
We'll continue our efforts to expand our global geographic footprint of DANYELZA 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 to 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 2020. Starting with DANYELZA. For anyone who may be newer to Y-mAbs, let me remind you that DANYELZA was approved in the U.S. approved by the U.S. Fda for the 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. Neuroblastoma is the most common cancer in infants, the third most common cancer of children. We finished 2023 on a strong note, achieving $23.4 million in net product sales of DANYELZA 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 ex U.S. regions. We're pleased to have achieved an annual 2023 net product revenue for DANYELZA of $84.3 million, which was near the top end of our previously raised guidance range of between $80 million and $85 million. This was an increase of 71% compared to full year 2022.
Progress is remarkable and indicates increasing adoption of DANYELZA across approved regions worldwide. We continue to gain momentum in the U.S. with a number of new accounts as of December 31st, 2023, with 58 active sites across the U.S. Since DANYELZA initial launch with 10 new accounts added in 2023. Our ex U.S. footprint continues to expand through multiple partnerships. The DANYELZA launch in China is progressing well and this January, we accepted the price for DANYELZA Costa from the Brazilian medicines market regulation chamber or CME day. We expect to launch DANYELZA in Brazil in 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 quarters.
Our European early access program with what pharma clinical because 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 BLA for DANYELZA 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 on longer. Ongoing ISS. sponsored naxitamab trials in support of our indication expansion strategy. In particular, we look forward to Memorial Sloan Kettering readout from its multi-center Phase 2 trial investigating axatilimab in patients with relapsed osteosarcoma in the fourth quarter of this year. You will hear more about the progress of the ongoing exit of our trials from Devesh later on.
Now let me shift to our software platform. Before I provide a brief update on our lead programs, I want to take a moment to set the stage about some of the current challenges related to commercialization administration and manufacturing infrastructure of target radiopharmaceutical therapies. There are four key areas. First, infrastructure manufacturing. There's an enormous investment currently ongoing into specialized radiopharmaceutical manufacturing facilities for targeted radiopharmaceutical therapies made once the therapy is made and released. There's a very limited time window which to deliver that therapy to patients before it expires.
Second is physician participation, which has always been an issue with current radiopharmaceuticals, the oncologist needs to refer the patient to an off-price physician that can prescribe and administer radiopharmaceuticals, traditionally a nuclear medicine physician. The Oncologist is essentially removed from his or her patient's treatment journey at this time.
Third, there's 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 limited number of these across the globe.
And fourth, continued drug shortages are an issue as current demand is increasing for radiopharmaceuticals 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 Tata credit creators 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. We are leveraging the existing infrastructure within infusion centers, oncologists offices, freestanding infusion centers and outpatient centers. We administer side affreightment two step process first, the patient to receive the non-radio episodic and existing centers.
And for the second step, the isotope infusion can be delivered at a nuclear medicine department for license imaging centers because we are 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. And importantly, Cytopoint can be isotope agnostic as long as we can create linkers between the isotope and the sort of 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 decreased toxicity levels to patient while increasing the targeted activity to tumors. We're very excited about the potential of cytokine to improve patient experience and expand radiopharmaceutical treatment landscape.
Now let's turn to a brief update on our lead programs. Our Phase 1 GD. two, Santa As a reminder, our Phase 1 trial evaluating the safety and tolerability of GD. two data in the treatment of GD2 positive solid tumors, including small cell lung cancer sarcomas and malignant melanoma got underway in March of 2023. This Phase 1 dose escalation single arm, multicenter safety study has three parts our day explores dose-finding for GD. two start-up molecule testing of dose intervals of two to five days between the protein and the lutetium one seven seven Delta payload. Part B determines the optimal dose of lutetium one 77 data and Part C evaluates the safety and initial signs of efficacy using repeat dosing. 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. We are currently in Part A. and are very pleased with how the trial is progressing. We have advanced through cohorts one, two and three and are now dosing patients in Cohort four. We have dosed a total of 10 patients to date, we currently have six active sites and plan to continue adding additional sites. Recall that part of the trials investigating the safety profile of the protein in determining the optimal time to deliver the radionuclide. We are very, very encouraged by what we have seen so far to date, no patients have experienced any dose-limiting toxicities based on spec CT scans and PK activity we have seen to date, we believe that we have demonstrated proof of concept, namely the GD. to Sonic and help find and buy into tumors that is important to note that this early data are not complete and are not necessarily indicative of a full results for the ultimate success of the trials or the Cyota development program. We expect to share data from Part A. of this Phase 1 study, a medical meeting in the second half of this year.
Our second product upgrade program, CD. 38 data, which will plans which we plan to first study in patients with non-Hodgkin's lymphoma, focusing M B and T-cell lymphoma. This our first set a program to be studied in blood cancer. Our IND has been approved by the FDA. And as you can see here, our planned Phase 1 follows a comparable design to our GD. two satellite program. We are on track to enroll two sites in April and expect to dose the first patients in this Phase 1 trial this year. We believe the potential of the radiopharmaceutical industry has had a huge inflection point and peaking the interest of physicians and patients alike. We truly believe that Satish novel and differentiated approach has the potential to become the targeted radiopharmaceutical delivery pack platform choice in the treatment of multiple solid tumors and blood cancers.
I will now pass the call over to Sue Smith to provide further color on DANYELZA sales for the fourth quarter and full year 2023. Sue?

Susan Smith

Thank you, Mike, and good morning, everybody. Before I discuss some of the key highlights from DANYELZA, the US 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 DANYELZA campaign aimed to reposition and elaborate on DANYELZA as differentiating characteristics in the treatment of neuroblastoma from patients who have experienced 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 regarding DANYELZA of performance in two different patient populations, those patients with an incomplete response to induction therapy also in addition to patients who are relapse.
In addition, the new campaign demonstrates DANYELZA response in children after prior anti GD2 therapy, we continue to expect meaningful traction from the new campaign over the coming quarters. I'm really pleased with the positive initial feedback in the form of commercial progress of DANYELZA in the US that we saw in just the fourth quarter. The excuse me, for the fourth quarter of 2023, we increased DANYELZA 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 initial launch back in 2021. And we believe we have room for continued growth.
As Mike mentioned, we recorded $84.3 million in DANYELZA net product revenues for the full year 2023, achieving the high end of our updated net product revenue guidance range of between $80 million to $85 million. A total of 58 accounts have now use DANYELZA around the U.S. Since its initial launch in 2021 with 10 new accounts added in 2023. We believe physicians are getting more comfortable using DANYELZA or with 41 HCPs having prescribed DANYELZA in 2023, including eight HCPs starting two or more patients in the year. Since launch, a total of 93 healthcare practitioners have prescribed DANYELZA and 28 HTP.s have started treatment in two or more patients as of December 31st, 2023. Our U.S. commercial sales team continues to receive positive HTP. feedback on DANYELZA through ongoing customer interactions. In addition, we continue to see institutional adoption of DANYELZA up, which has been added to six hospital formularies in 2023, bringing the total since launch to 42 hospital formularies as of December 31st, 2023 DANYELZA or remains a leading therapy in the U.S. anti GD. to 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.

Vignesh Rajah

Thank you, Susan, and hello, everyone. I'm pleased to provide a brief update on our ongoing naxitamab clinical trials. We continue to advance potential label expansion opportunities for DANYELZA through our investigator-sponsored clinical studies in collaboration with leading KOLs in the front-line high-risk neuroblastoma setting. We have partnered with beats Childhood Cancer Research Consortium or BCC in a multi-center Phase 2 trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma.
As of February, the 12th, 2024 and 13 sites have been initiated and seven patients have been dosed study is expected to transition from a single-arm study with naxitamab added to current standard treatment of induction. So a randomized study with a control arm will be the current standard of care for induction therapy, which is chemotherapy plus or minus alpha inhibitor. Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy in the next set of months collection of arm 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 from axatilimab. We continue to expect MSK to provide data readout from this Phase 1 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 in breast cancer. We have partnered with the Ohio State University on a Phase 1b/2 trial investigating TGF beta NK cells, gemcitabine plus nivolumab in patients with GD. two positive metastatic breast cancer. First patient is expected to be dosed DANYELZAon in the first half of this year. From the outcome of this trial, we would consider moving forward with a multicenter Phase 2 trial. We continue to advance our strategy aimed at unlocking the full potential value of Nexavar for patients beyond those impacted by relapsed or refractory harvesting neurovascular and fully believe there still remains significant potential in the anti GD2 space in both pediatric and adult cancers. We look forward to updating you on our progress.
Let me now hand over the call to Bo Kruse.

Bo Kruse

Thank you, Vignesh, and good morning, everyone. Some years the net product revenues of $84.3 million for the year ended December 31st, 2023, representing 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 tenures on net 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 of 2023 as we saw increases from U.S. revenues as well as from international revenues. US 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 ended December 31st, 2022, and then license revenue for the three months ended December 31st, 2023.
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 31st, 2023, respectively, compared to the same periods of 2022 the net decrease was primarily due through The decreased spending on de-prioritize 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 $4.1 million accrual of time-based clinical milestones related to our Saphion technology.
Selling general and administrative expenses decreased by $0.3 million and $16.1 million to $11.1 million and $44.9 million for the three months and year ended December 31st, 2023, respectively, compared to the same periods in 22. The decrease in SG&A for the year ended December 31st, 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 22 in anticipation of a potential convert on MetLife.
We reported net loss for the quarter ended December 31st, 2023 of just $1 million or $0.02 per share basic and diluted, compared to net income of $1.2 million or $0.03 per share. Basic and diluted for the quarter ended December 31st, 2022, which included a regulatory based milestone of $50 million from Xicom Pharmaceuticals for the conditional approval of 10 years in China in 2022. Additionally, we reported a net loss for the year ended December 31st, 2023 of $21.4 million, or $0.49 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. The decrease in net loss was primarily driven by higher product revenues, lower R&D expenses, low 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 23 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 full year Importantly, we reduced our annual cash used from $75.8 million to $27.1 million or about 64% in 23 compared to 2022.
Now let me turn to our financial guidance for the full year 2024. We expect full year 2020, both yields and net product 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 2023.
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 and total expected cash burn for the full year 2024 to range from $15 million to $20 million, a midpoint decrease of approximately 35% from 2023. We continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently planned 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 for 10 years, the net product revenues are assumed to increase by 10% each year from 24 to 2027. We hope to see a higher growth rate for DANYELZAon as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater physician 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, I 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.

Michael Rossi

Thank you for that overview. Bo, let's open the line for questions. Operator?

Question and Answer Session

Operator

(Operator Instructions) Alec Stranahan, Bank of America.

Alec Stranahan

Hey, guys, thanks for taking our questions. I'm just just a couple from us. First on DANYELZA, 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 Cyota update and later this year, could you maybe help frame the party data we should expect in the second half? Do you think we'll get a good idea of dosing schedule and or tumor localization and the update or will the focus really be more on safety since this is the first in-human study.

Michael Rossi

Thanks And Alex, thank you very much. Appreciate it.
And I'll start with the second question.
First on the site update, these data update, it's going to be focused on Part A. of the Phase 1 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 is what dose will be from the side of protein load and what the dosing interval will be between the protein administration and the lutetium payload so that there are really the two points that we're looking for.
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 in some visual images as well as part of that.
So the first part of your question, talking about the ex U.S. sales. I'll pass that off to Bo, and Bo will give you a little bit more color on the division between the you have some extra sales.

Bo Kruse

Yes, sure. Thank you, Mike. So as you already know that the fourth quarter split was so that the US sales were about 82% of the total product sales and for the full year's US Canada for about 80%. So in terms of budgeting and guidance, we've been quite conservative on the international contribution. So it is it reduced about five to eight basis point compared to what we saw in 2023 just to be conservative.

Alec Stranahan

Great thank you.

Operator

David Nierengarten, Wedbush Securities.

David Nierengarten

Thanks for taking my question. Maybe this is a question too far ahead to think about, but I was curious about on your ability to use different isotopes with Cyota platform and if there were any plans to compare you have the safety and efficacy of different isotopes with the same, we are with the same target the same patient population. So I don't know if you have that answer, but that's my question.

Michael Rossi

Thanks, David and I appreciate it. It's never too early to start thinking about that or moving forward. One of the challenges that I spoke to is the ability to we 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 on what you can do when you can do it. Halfway determines a lot of that. So it's really challenging for some some organizations report for us taking the isotope agnostic approach since we don't need a manufacturing facility that put the drug and the Asia talk together on prior to injection, the patient, the patient actually becomes that that production facility, right? 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 data platform, which will change. So our GD. two Cyota construct that we go forward with will be final drug product outside.
The next part is right now we're using data cage the tissue as we move forward and investigate other isotopes hedges as lead Oxinium, even getting into the coffers or fluorines Galyan's gives us the opportunity to then mix-and-match and comparisons will be inevitable and which is a good thing.
But you know, for some of these things like lutetium, there is 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 these isotopes look like so but approaching it from the fact that we're not limited to putting these together outside of the patient that it happens with the patient, we have more ability to go forward and allow physicians to them to select the isotope if 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 physicians to treat individual patients.

David Nierengarten

I appreciate it. Thank you.

Operator

(Operator Instructions) Etzer Darout, BMO Capital Markets.

Lukas Shumway

Hi. Lukas Shumway on for Etzer. Thanks for taking my question. Can I ask about your thoughts around the C 30, any sort of program that landscape is obviously evolving with Genmab and J&J kind of having a death grip with Darzalex, what kind of gives you confidence in on the cyto approach in targeting CD38?

Michael Rossi

Yes. So look, I appreciate the very good question. We've selected two targets on to start one IGD. two since we have a tremendous amount of experience with DANYELZA and the GD. two platform.
The second component is a lot of in-house domain knowledge associated with CD. 38 and the second component is just looking at the overall ability to treat solid tumors as well as circulating tumors with systemic radiotherapy. We know historically non-Hodgkin's lymphoma is very, very sensitive and we've seen this with some early drugs and in early trials. 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 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, we know actually start targeting targeting some of the trading of sensitive tumors. The we don't want to shy away from an area, but just because there is competition and competition is good and the ability to get patients and physicians choices on treatment, that's something that I'm this cornerstone in in pharmaceutical markets.

Lukas Shumway

Okay. And then if I could, one more for the GD2 sort of Part A, what is your measure for success? Like what's your go, no-go that you're looking for. I mean, it's a safety study, right?

Michael Rossi

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 continuing the pain to tumors and bigger of a basket trial were also this is in a situation where we just took on a protein injected into the to healthy humans and determined that it is safe on its own. We're also injecting the radioactivity with it, which is giving us additional information on tumor expression on tumor uptake as well as what term what cancers may be more susceptible or more have a better affinity for TD. two solder. So it's really information collecting, and it allows us to then move some variables as we move into Phase 2. But we're very happy with how the safety trials progressing too much actually.

Lukas Shumway

Thank you.

Operator

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 Y-mAbs for the strong financial foundation and the right team in place, we believe Y-mAbs is positioned to continue to continue improving outcomes for patients and families impacted by childhood cancers at the same time, potentially shifting the treatment paradigm for a variety of both pediatric and adult cancers with our novel pre targeted radioimmunotherapy platform.
We're very encouraged by the early data we've seen so far are incredibly excited about the potential of data prep to emerge as the preferred radiopharmaceutical 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.

Operator

Thank you. This concludes today's conference call and you may disconnect your lines at this time. Thank you for your participation.

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