Disco Q4 2023 Earnings Call Transcript

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Provided by Quartr
March 1, 2024

There are 8 speakers on the call.

Operator

Good morning, and welcome to the Wymabs Therapeutics Earnings Conference Call for the 4th 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. As a reminder, today's conference will be recorded. I'll now turn the call over to Ymab's Head of Investor Relations, Courtnee Dugan.

Speaker 1

Thank you, operator, and good morning, everyone. Welcome to the Ymab's Q4 and full year 2023 financial results conference call. We issued a press release with our results yesterday after market close. 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.

Speaker 1

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 our research and development programs 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 development programs potential for Daniela's territory and label expansion and potential of and advancement of SADA, 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 and items and expectations for 2024 and beyond and our financial performance, including our estimates regarding revenues, expenses and capital expenditure requirements 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 annual report on Form 10 ks for the year ended December 31, 2023, as filed with the SEC on February 29, 2024.

Speaker 1

With that, I'd like to now turn the call over to our President and CEO, Mike Raffi.

Speaker 2

Thank you, Courtney. Good morning, everybody, and thank you for joining us. I have with me today our Chief Financial Officer, Beau Krause our Chief Commercial Officer, Sue Smith and our Chief Medical Officer, Doctor. Banish Raja. Thomas Gatt, our Founder and Chief Business Officer and Doctor.

Speaker 2

Steen Lidsby, our Chief Scientific Officer will join us for the Q and A portion of this call. On today's call, I will begin by reviewing our Q4 and full year 2023 global highlights on Daniella sales and updates on our clinical program utilizing our self assembly disassembly pre targeted radio immune therapy or SODA plus technology platform. Next, Sue will report further insights into our global DANIELZA sales in the Q4. Dinesh will then provide updates around our ongoing narsitamab clinical trials. Bo will then provide an overview of our Q4 and full year 2023 financial performance, our cash resources and our full year 2024 guidance before we open the line for Q and A.

Speaker 2

2023 was an important year for Ymabs. With the completion of our restructuring plan earlier last year, Ymabs emerged as an innovator in radiopharmaceutical therapy development based on our novel and differentiated pre targeted radio immune therapy platform, SODACRIT, complemented by our commercial antibody therapy, Danielza, driving annual revenue growth. In addition to our more focused pipeline, we reduced our cash use of cash to only $27,100,000 in the full year 2023 as a direct result of our effective capital management strategy in action. With $78,600,000 in cash and cash equivalents as of December 31, 2023, we believe we have sufficient financial resources to advance the clinical development of our Sotaprit platform, while continuing our efforts to expand our global geographic footprint of Daniela 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 YmAb's employees.

Speaker 2

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 Q4 full year 2020 3, starting with Daniela. For anyone who may be newer to Ymabs, let me remind you that Daniela is approved by the U. S. 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 therapies.

Speaker 2

Neuroblastoma is the most common cancer in infants, the 3rd most common cancer in children. We finished 2023 on a strong note, achieving $23,400,000 in net product sales of Danielle's in the 4th quarter, an increase of 42% from what we recorded in the Q4 of 2022 and an increase of 17% versus the Q3 of 2023. Through continued market penetration across high volume U. S. Accounts and in ex U.

Speaker 2

S. Regions, we are pleased to have achieved an annual 2023 net product revenue for Daniela of $84,300,000 which was near the top end of our previously raised guidance range of between $80,000,000 $85,000,000 This was an increase of 71% compared to full year 2022. The progress is remarkable and indicates increasing adoption of VAMELZA across approved regions worldwide. We continue to gain momentum in the U. S.

Speaker 2

With a number of new accounts. As of December 31, 2023, we had 58 active sites across the U. S. Since Daniela's initial launch with 10 new accounts added in 2023. Our ex U.

Speaker 2

S. Footprint continues to expand through multiple partnerships. The Daniela launch in China is progressing well. In this January, we accepted the price for Daniela from the Brazilian Medicines Market Regulation Chamber or CMED. We expect to launch Daniela in Brazil and Mexico in the Q2 of this year with our partner, Adium, and look forward to providing progress updates on this anticipated launch in the coming quarters.

Speaker 2

Our European Early Access Program with Lip Pharma Clinical is continuing to progress as we support the needs of children with high risk relapsedrefractory neuroblastoma in Europe. In addition, we plan to submit a VLA for Daniela in Argentina this year and could potentially receive additional approval in Asia and Hong Kong within the next 18 months. In addition to geographic expansion, we continue to see progress among our ongoing ISS sponsored naxitamab trials in support of our indication expansion strategy. In particular, we look forward to Memorial Sloan Kettering's readout from its multicenter Phase 2 trial investigating naxitamab in patients with relapsed osteosarcoma in the Q4 of this year. You will hear more about the progress of the ongoing naxitamab trial from Dinesh later on this call.

Speaker 2

Now let me shift to our SADA3 platform. Before I provide a brief update on our lead programs, I want to take a moment to set the stage around some of the current challenges related to commercialization, administration and manufacturing infrastructure of targeted radiopharmaceutical therapies. There are 4 key areas. 1st, infrastructure manufacturing. There's an enormous investment currently ongoing into specialized radiopharmaceutical manufacturing facilities where targeted radiopharmaceutical therapy is made.

Speaker 2

Once the therapy is made and released, there's a very limited time window, which to deliver that therapy to patients before it expires. 2nd is 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. The oncologist is essentially removed from his or her patient's treatment journey at this time. 3rd, there's a limited number of administration sites capable of handling radiopharmaceuticals.

Speaker 2

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 4th, 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 Sautoprid 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 freestanding infusion centers and outpatient centers.

Speaker 2

We administer SOTA print in a 2 step process. First, the patient can receive a non radioactive SOTA in existing centers. Then for the 2nd step, the isotope infusion can be delivered at a nuclear medicine department or licensed imaging centers. Because we are leveraging the existing infrastructure, we are increasing physician participation and we are able to have more engagement with oncologists, specialists and nuclear medicine physicians, which we believe will lead to better overall results. Importantly, SOTAPRIC can be isotope agnostic.

Speaker 2

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 decreased toxicity levels to patient while increasing the targeted activity to tumors. We're very excited about the potential of sotoprit to improve patient experience and expand radiopharmaceutical treatment landscape. Now let's turn to a brief update on our lead programs. Our Phase 1 GD2 SADA.

Speaker 2

As a reminder, our Phase 1 trial evaluating the safety and tolerability of GD2 SADA 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 multi center safety study has 3 parts. Part A explores dose finding for GD2 SADA molecule and the testing of dose intervals of 2 to 5 days between the protein and the lutetium-one hundred and seventy seven dota payload. Part B determines the optimal dose of lutetium-one hundred and seventy seven donor and Part C evaluates the safety and initial signs of efficacy using repeat dosing. Dose escalation is based on 2 patients in Cohort 12 followed by a modified 3 plus 3 design.

Speaker 2

Is important to emphasize that in each cohort patients will be observed after dosing in a so called 6 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 1, 23 and are now dosing patients at Cohort 4. We have dosed a total of 10 patients to date. We currently have 6 active sites and plan to continue adding additional sites.

Speaker 2

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 toxicities. Based on the spec CT scans and PK activity we have seen to date, we believe that we have demonstrated proof of concept, namely that GD2SADA can both find and bind 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 success of the trials or the SADA development program.

Speaker 2

We expect to share data from Part A of this Phase 1 study at a medical meeting in the second half of this year. Our second SADA Prick program is CD38 SADA, which we will plan 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 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 GD2 SADA program.

Speaker 2

We are on track to enroll 2 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 is at a huge inflection point and piquing the interest of physicians and patients alike. We truly believe that SADA's novel and differentiated approach has the potential to become the target radiopharmaceutical delivery platform of 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 U. S.

Speaker 2

Daniela sales for the Q4 and full year 2023. Sue?

Speaker 3

Thank you, Mike, and good morning, everybody. Before I discuss some of the key highlights from Daniela U. S. Sales in the Q4, let me provide a brief review of the enhanced marketing efforts our commercial team launched throughout the Q4 of last year. We have successfully rolled out a new Daniela's campaign aimed to reposition and elaborate on Daniela's differentiating characteristics in the treatment of neuroblastoma for patients who have experienced incomplete response to induction therapy in their bone and bone marrow.

Speaker 3

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 Daniela's performance in 2 different patient populations. Those patients with an incomplete response to induction therapy, also in addition to patients who are relapsed. In addition, the new campaign demonstrates Daniela's response in children after prior anti GD2 therapy. While 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 Danielza in the U. S.

Speaker 3

That we saw in just the Q4. For the Q4 of 2023, we increased Daniela's net product revenues by 42% year over year to $23,400,000 compared to the Q4 of 2022. That is a 17% increase compared to the Q3 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 $84,300,000 in Daniela net product revenues for the full year 2023, achieving the high end of our updated net product revenue guidance range of between $80,000,000 $85,000,000 dollars A total of 58 accounts have now used Daniela around the U.

Speaker 3

S. Since its initial launch in 2021 with 10 new accounts added in 2023. We believe physicians are getting more comfortable using Danielza with 41 HCPs having prescribed Danielza in 2023, including 8 HCPs starting 2 or more patients in the year. Since launch, a total of 93 healthcare practitioners have prescribed Danielza and 28 HCPs have started treatment in 2 or more patients as of December 31, 2023. Our U.

Speaker 3

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 6 hospital formularies in 2023, bringing the total since launch to 42 hospital formularies as of December 31, 2023. Daniela remains a leading therapy in U. S.

Speaker 3

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.

Speaker 4

Thank you, Sue, and hello, everyone. I'm pleased to provide a brief update on our ongoing Nexitimab clinical trials. We continue to advance potential label expansion opportunities for Daniela 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 multicenter Phase 2 trial evaluating naxitamab in combination with standard induction therapy for patients with newly diagnosed high risk neuroblastoma. As of February 12, 2024, 13 sites have been initiated and 7 patients have been dosed.

Speaker 4

The study is expected to transition from a single arm study, I. E. With naxitamab added to current standard treatment of 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 ALK inhibitor. Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy in the naxitamab and naxitamab versus standard of care. We expect to potentially initiate the new randomized study in the Q2 of this year.

Speaker 4

In osteosarcoma, we are continuing to work with Memorial Sloan Kettering on its multi centered investigator sponsored trial from axitamab. We continue to expect MSK to provide data readout from this Phase III trial in the Q4 of this year. And based on the outcome of this, we will evaluate plans for our randomized trial to be initiated in the Q2 of 2025. In breast cancer, we have partnered with the Ohio State University on a Phase 1btwo trial investigating TGF beta NK cells, gemcitabine plus nuxedumab in patients with DD2 positive metastatic breast cancer. The first patient is expected to be dosed with Daniela in the first half of this year.

Speaker 4

Upon the outcome of this trial, we would consider moving forward in a multicenter Phase II trial. We continue to advance our strategy aimed at unlocking the full potential value of Nexitomo for patients beyond those impacted by relapsed or refractory high risk neuroblastoma. We 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 Cruz.

Speaker 5

Thank you, Vignesh, and good morning, everyone. Sanyoza net product revenues of $84,300,000 for the year ended December 31, 2023, represented an increase of 71% from the $49,300,000 reported for the year ended December 31, 2022. The increase of $35,000,000 was primarily driven by an increase in new U. S. Patients and an incremental benefit from expanding international revenues.

Speaker 5

Our global Danielson net product revenues of $23,400,000 for the Q4 2023 represented a 42% increase compared to the Q4 of 2022 and a favorable 17% increase compared to the Q3 of 2023 as we saw increases from U. S. Revenues as well as from international revenues. U. S.

Speaker 5

Revenues increased 19 percent to $19,100,000 in the 4th quarter compared to $16,100,000 in the Q3 of 2023, and international revenues increased 11% to $4,300,000 in the 4th quarter compared to $3,900,000 in the 3rd quarter. We reported $15,000,000 worth of license revenue in the 3 months ended December 31, 2022, and didn't have license revenue for the 3 months ended December 31, 2023. Moving to operating expenses. Our research and development expenses decreased by $6,400,000 37,400,000 dollars to $13,400,000 $54,200,000 for the 3 months year ended December 31, 2023, respectively, compared to the same periods of 2022. The net decrease was primarily due to the decreased spending on deprioritized 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.

Speaker 5

The decrease was partially offset by $4,100,000 accrual of time based clinical milestones related to our SARA technology. Selling, general and administrative expenses decreased by $300,000 $16,100,000 to $11,100,000 44 point $9,000,000 for the 3 months year ended December 31, 2023, respectively, compared to the same periods in 2022. The decrease in SG and A for the year ended December 31, 2023, was primarily attributable to a $10,900,000 charge related to the departure of our former Chief Executive Officer in Q2 2022 and to a lesser extent, a $3,400,000 decrease in commercialization expenses compared to expenses incurred in 2022 in anticipation of a potential omburtamab launch. We reported net loss for the quarter ended December 31, 2023, of just 1,000,000 dollars or $0.02 per share basic and diluted compared to net income of $1,200,000 or $0.03 per share basic and diluted for the quarter ended December 31, 2022, which included a regulatory based milestone of $15,000,000 from cyclone Pharmaceuticals for the conditional approval of Danielson in China in 2022. Additionally, we reported a net loss for the year ended December 31, 2023, of $21,400,000 or $0.49 per share basic and diluted compared to a net loss of 90 $5,600,000 or $2.19 per share basic and diluted for the year ended December 31, 2022.

Speaker 5

The decrease in net loss was primarily driven by higher product revenues, lower R and D expenses, lower SG and A expenses, inclusive of the $10,900,000 decrease for the charge related to the departure of the company's former CEO in Q2 2022. As mentioned earlier, we ended the Q4 2023 with cash and cash equivalents of $78,600,000 compared to $105,800,000 at year end 2022. The decrease was $27,100,000 for the full year. Importantly, we reduced our annual cash used from $75,800,000 to $27,100,000 about 64% in 2023 compared to 2022. Now let me turn to our financial guidance for the full year 2024.

Speaker 5

We expect full year 2024 Danielson net product revenues to be in the range of $95,000,000 to $100,000,000 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 $115,000,000 to $120,000,000 reflecting a midpoint increase of approximately 6% compared to 2023. And in total, expected cash burn for the full year 2024 to range from $15,000,000 to $20,000,000 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 into 2027. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand.

Speaker 5

For the purpose of this specific analysis of our cash runway only, the Danielson net product revenues are assumed to increase by 10% each year from 24% through 2027. We hope to see a higher growth rate for Daniilza 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 are assumed at this point for purposes of the analysis. We believe YMAbbs 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.

Speaker 2

Thank you for that overview, Beau. Let's now open the line for questions. Operator?

Operator

Thank you. At this time, we'll be conducting a question and answer Our first question comes from the line of Alec Stranahan with Bank of America. Please proceed with your question.

Speaker 6

Hey, guys. Thanks for taking our questions. Just a couple from us. First on Danielza, what kind of ex U. S.

Speaker 6

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. 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 dosing schedule and or tumor localization in the update?

Speaker 6

Or will the focus really be more on safety since this is the first in human study? Thanks.

Speaker 2

Hey, Alex, thank you. Much appreciated. I'll start with the second question first on the SADA update. The SADA update is going to be focused on Part A of that Phase I 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 the dose will be from the SATA protein load and what the dosing interval will be between the protein administration and the lutetium payload.

Speaker 2

So they're really the two points that we're looking for. And again, this is a pure safety study. 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.

Speaker 2

Sales, I'll pass that off to Bo and Bo can give you a little bit more color on the division between the U. S. And the ex U. S. Sales.

Speaker 5

Yes, sure. Thank you, Mike. So as you already noted, the 4th quarter split was so that the U. S. Sales were about 82% of the total product sales.

Speaker 5

And for the full year, the U. S. Accounted for about 80%. So in terms of budgeting and guidance, we've been quite conservative on the international contribution. So it's reduced about 5 to 8 basis points compared to what we saw in 2023, just to be conservative.

Speaker 6

Great. Thank you.

Operator

Thank you. Our next question comes from the line of David Nierengarten with Wedbush Securities. Please proceed with your question.

Speaker 6

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

Speaker 2

David, no, I appreciate it. And 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 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. Half life determines a lot of that.

Speaker 2

So it's really challenging for some organizations to move forward. For us taking the isotope agnostic approach, since we don't need a manufacturing facility to put the drug and the isotope together prior to injection in the patient, the patient actually becomes 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 SATA platform, which won't change. So our GD2 SADA construct that we go forward with will be the final drug product, Camaroside.

Speaker 2

The next part is right now we're using, DOTACAGE Lutetium. As we move forward and investigate other isotopes such as lead, actinium, even getting into the coppers or fluorines, galliums, it gives us the opportunity to then mix and match and comparisons will be inevitable and which is a good thing. But for some of these things like Lutetium, there's a pretty good safety and 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 what 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 to the patient.

Speaker 2

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 of physicians to treat individual patients. Thanks. Appreciate it.

Operator

Thank you. Our next question comes from the line of Etzer Dharu with BMO Capital Markets. Please proceed with your question.

Speaker 7

Hi, Luke Chamboyant on for Etzer. Thanks for taking my question. Can I ask about your thoughts around the C38 SADA program that landscape is obviously evolving with like Genmab and J and J kind of having a death grip with DARZALEX? What kind of gives you confidence in the SADA approach in targeting CD38?

Speaker 2

That's look, I appreciate it. It's a very good question. We've selected 2 targets to start. 1, a GD2 since we have a tremendous amount of experience with Daniela and the GD2 platform. The second component is a lot of in house domain knowledge associated with CD38.

Speaker 2

The second component is 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 radio sensitive. We've seen this with some early drugs and 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 patients alternative to potential But that being said, we know as we start targeting some of these radiosensitive tumors, we don't want to shy away from an area just because there is competition. Competition is good and the ability to give patients and physicians choices on treatment It's something that I think is cornerstone in the pharmaceutical market.

Speaker 7

Okay. And then if I could one more for the GD2 SADA Part A, what is your measure for success? Like what's your gono go that you're looking for?

Speaker 2

Well, for us, 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 continuing to paint the tumors and being a basket trial. We're also this isn't a situation where we just took a protein injected into healthy humans and determine that it is safe on its own. 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 more has a better affinity for GD2 SADA.

Speaker 2

So it's really an information collecting and it allows us to then remove some variables as we move into Phase 2, but we're very happy with how the safety trial is progressing.

Speaker 7

Okay. Thanks so much.

Speaker 2

Thanks, Luke.

Operator

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

Speaker 2

Very good. I appreciate it. Thank you everybody for participating in today's Q4 and full year 2023 earnings call and for your continued interest in Ymab. With a strong financial foundation and the right hand in place, we believe YmAb is positioned to 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 SODIPRIT to emerge as the preferred radiopharmaceutical treatment platform of choice for physicians and their patients.

Speaker 2

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. You may disconnect your lines at this time. Thank you for your participation.

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