YMAB (2025 - Q1)

Good morning, and welcome to Y-mAbs Therapeutics First Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. Instructions for the question-and-answer session will follow the prepared remarks. As a reminder, today’s conference will be recorded. I would now like to hand the call over to Y-mAbs Head of IR, Courtney Dugan. Please go ahead. Courtney

Thank you, operator, and good morning, everyone. Welcome to the Y-mAbs first quarter 2025 financial results conference call. We issued a press release with our results this morning before the market opened. 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, commercialization and product distribution plans, expectations with respect to our business realignment, expectations with respect to clinical trial data, expectations related to current and future clinical and preclinical studies and our research and development programs and regulatory submissions, potential regulatory, marketing and reimbursement approvals, collaborations or strategic partnerships and the potential benefits thereof expectations related to our anticipated cash runway and cash investment and the sufficiency of our cash resources and assumptions related thereto, financial guidance and estimates for the first quarter and full-year of 2025 and beyond and other statements that are not historical facts. Because forward-looking statements involve risks and uncertainties, actual results may differ materially from those expressed or implied by such statements due to a variety of factors, including those risk factors discussed in the Company’s previously filed annual report on Form 10-K for the year ended December 31, 2024, as supplemented by the risk factors discussed in the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2025, to be filed with the SEC today. In addition, today’s discussion will include operating expenses, excluding cost of goods sold, which is a non-GAAP financial measure. A description of this non-GAAP financial measure and a reconciliation of the closest GAAP financial measure is included in today’s press release and in the slide presentation available on the IR section of our website at ir.ymabs.com. I would now like to turn the call over to our President and CEO, Mike Rossi.

Thank you, Courtney. Good morning, everyone, and thank you for joining us. Joining me today is Doug Gentilcore, our DANYELZA Business Unit Head; and Pete Pfreundschuh, our Chief Financial Officer. I will begin by reviewing key highlights from our business units from the first quarter and how those accomplishments align to our long-term strategy and then discuss our upcoming Radiopharmaceutical R&D event on May 28. Next, Doug will provide details on our global DANYELZA sales performance and commercial strategy. Then Pete will provide a detailed account of the first quarter financial results. We made excellent progress in the first quarter of this year following our business realignment announced in January. Just to remind everyone, the Company made the decision to establish two distinct internal business units, DANYELZA and Radiopharmaceuticals. The effort is expected to help maximize the potential of DANYELZA, while at the same time accelerating the development of our novel SADA PRIT platform and high-value target programs. In the first quarter, we recorded DANYELZA net product revenues of $20.9 million coming in at the higher-end of our guidance range we provided during our fiscal year-end 2024 earnings call in March. This represents an 8% increase from the first quarter of last year. Despite a challenging environment with multiple headwinds, I’m very proud of the team’s effort and resilience to deliver this caliber of results. We continue to be prudent in our spending and our financial position remains strong with $60.3 million in cash with an anticipated runway into 2027 based on our current operations. In our Radiopharmaceutical business unit, we completed Part A of our GD2-SADA Phase I clinical trial, Trial 1001 in solid tumors. Additionally, we successfully dosed the first patient in our CD38-SADA Phase I clinical trial, Trial 1201, in patients with Relapsed or Refractory non-Hodgkin Lymphoma. Our second clinical program evaluating our novel SADA PRIT platform and our first and hematologic malignancies. Relapsed or Refractory non-Hodgkin Lymphoma presents significant challenges for patients facing limited treatment options and a more aggressive disease course. We look forward to advancing our program in the trial and we’ll update you as it progresses. As you may have seen, this morning we announced we will hold a virtual Radiopharmaceutical R&D event on the morning of May 28. At that time, we will provide three key updates. First, the completed data from Part A of Trial 1001, our GD2-SADA Trial 1 clinical trial in solid tumors and next steps for the program. As a reminder, Part A of Trial 1001 is a dose-finding study. The data we plan to share will predominantly focus on the safety profile, dosing regimen and pharmacokinetic and dosimetry details. We anticipate the clinical data will align with our preclinical model to help understand tumor uptake, which will be critical as we move into Part 2 of the study. Second, we will review construct optimization as we move into the next stage of both our current and future programs. Specifically, we will outline changes to be made in the new construct for GD2-SADA and provide data supporting why we believe those changes will improve tumor uptake. Third, we will provide pipeline updates including new planned target programs and anticipated timeline. In the past, we’ve described our systematic evaluation to identify optimal targets for our platform. We will highlight the compelling commercial opportunities for extending radiation-based therapies to those indications and how we plan to do so with the fiscally prudent strategy. We look forward to providing you with these exciting updates on our Radiopharmaceuticals business unit in two weeks. Now, let me hand the call over to our DANYELZA Business Unit Head, Doug Gentilcore, to discuss our commercial progress.

Thank you, Mike, and good morning, everyone. In January, we executed an internal business unit realignment. For our DANYELZA business unit, the goal of this realignment was to enhance share of voice and our position within a competitive neuroblastoma U.S. market, increase penetration and utilization of DANYELZA in high-volume centers, and ultimately maximize the full-value of DANYELZA as an important anti-GD2 therapy. We believe DANYELZA has the potential to penetrate the U.S. market even further and increase physician utilization in high-risk relapsed/refractory neuroblastoma in bone and or bone marrow. DANYELZA is the only approved anti-GD2 therapy in that specific indication supported by a differentiated mechanism with proven clinical results. We are closely working with investigator sponsors on their trials to advance DANYELZA into potential new indications to further bolster its commercial potential. Our DANYELZA team continues to build relationships with new key institutions that have historically not been users of YmAb’s differentiated anti-GD2 therapy. We see this as a real opportunity to add additional high-volume institutions and grow DANYELZA’s market share. We are excited to be kicking off a new naxitamab investigator sponsored trial being led by key members of the Children’s Oncology Group or COG. We have a lot of interest from additional COG sites to work with us on even more investigator sponsored trials, evaluating naxitamab and other indication and lines of treatment, and we look forward to working with these sites going forward. We believe this activity, in combination with our ongoing work with the Beat Childhood Cancer Consortium, or BCC and The New Approaches to Neuroblastoma Treatment Consortium or NANT will further grow DANYELZA’s utilization and expand our market reach. We look forward to sharing these updates on these new partnerships as activities progress. Let’s now take a look at some commercial highlights in the first quarter of 2025. We are pleased to have achieved the upper-end of our first quarter guidance with total net DANYELZA product revenues of $20.9 million in the first quarter of 2025, an 8% increase compared to the prior year period. Ex-U.S.A DANYELZA net product revenues were $7.5 million an increase of $6.7 million compared to the prior year period, driven primarily by our named patient program in Western Asia, which launched in late 2024 as well as product growth in Eastern Asia and Latin America. In the U.S., total net product revenues for the first quarter were $13.4 million down 28% from the prior year period. The decrease was driven by a number of factors. Coming out of the end of 2024 and into the first quarter of 2025, the Company saw new patient enrollment slow largely due to competitive pressure from high enrollment of patients in clinical studies and competitive market dynamics, including continued use of available maintenance therapy. Additionally, some of our largest customers’ ordering patterns contribute to the year-over-year U.S. revenue decrease. As part of our business unit realignment, we have focused our DANYELZA’s commercial operations around accelerating our advocacy development, increasing new patient starts, expansion into new high-volume commercial accounts and highlighting financial advantages of DANYELZA. All three of these areas of focus have shown positive returns towards the end of the first quarter and into the second quarter of 2025. One key update since our last call that DANYELZA, in combination with chemotherapy, has been added to the NCCN guidelines for the treatment of relapsed or refractory neuroblastoma. With DANYELZA now included in the NCCN guidelines, we believe this will lead to even more support and interest in our differentiated therapy for relapsed/refractory high-risk neuroblastoma. We believe DANYELZA’s addition to the NCCN guidelines, coupled with new anticipated investigator sponsored studies at some of the most influential institutions will position DANYELZA back on a growth trajectory in the U.S. With that, I’ll hand the call over to Pete for a broader financial update.

Thank you, Doug, and good morning, everyone. As you heard earlier, we recorded total DANYELZA net product revenues of $20.9 million in the first quarter of 2025, representing an 8% increase compared to $19.4 million total DANYELZA’s net product revenues in the first quarter of 2024. The increase was primarily due to an increased Ex-U.S. net product revenues of $6.7 million which was partially offset by $5.2 million decrease in U.S. DANYELZA’s net product revenues for the first quarter of 2025 compared to the first quarter of 2024. Ex-U.S. net product revenues were $7.5 million and $0.8 million for the three months ended March 31, 2025 and 2024, respectively, representing an 816% increase. The increase in Ex-U.S. net product revenues was driven by named patient program in Western Asia, which was launched in late 2024 and an increase in net product sales in Eastern Asia and Latin America. We did not have any licensing revenue for the three months ended March 31, 2025, and we recorded $0.5 million of licensing revenue in the three months ended March 31, 2024. Research and development expenses were $11.4 million and $13.3 million for the quarters ended March 31, 2025 and 2024, respectively. The $1.9 million decrease in research and development expenses was primarily attributable to a decrease of $0.7 million in clinical trials due to the timing of completion in our Phase I GD2-SADA Trial 1001, investment in our ongoing SADA PRIT programs and a $0.9 million decrease in personnel and stock-based compensation costs, partially offset by $0.6 million increase in outsourced manufacturing and investment in our naxitimab program. Selling and general administrative expenses increased $1.7 million to $13.1 million for the quarter ended March 31, 2025, compared to $11.4 million in the same period of 2024. The $1.7 million increase in selling, general and administrative expenses was primarily attributable to a $0.8 million increase in personal and stock-based compensation costs, a $0.5 million charge related to our business realignment and a $0.4 million increase in legal expenses recorded in the three months ended March 31, 2025. We have reported a net loss for the quarter ended March 31, 2025 of $5.2 million or a negative $0.12 per basic and diluted share as compared to a net loss of $6.6 million or a negative $0.15 per basic and diluted share for the quarter ended March 31, 2024. The decrease in net loss for the quarter ended March 31, 2025 was primarily driven by an increase in net product revenues and a favorable impact from foreign currency transactions. With our business unit realignment strategy announced in January of this year, we have now organized into two internal business units, DANYELZA and Radiopharmaceuticals. Our business units are focused on different products and platforms. They are managed separately as business units require and also require different research, development, marketing, and operational investments. Their segment profit and losses from operations also include certain non-cash costs. Our DANYELZA business unit reflects a segment profit from operations of $8.8 million which was a 42% segment profit margin based on total revenues of $20.9 million for the first quarter of 2025. Segment profit from operations during the first quarter of 2024 was $8.7 million or 44% segment profit margin based on total revenues of $19.9 million. Our Radiopharmaceuticals business unit reflects a segment loss or investment from operations of $6.1 million and $6 million for the first quarters of 2025 and 2024 respectively. As mentioned earlier, we ended the first quarter of 2025 with cash and cash equivalents of $60.3 million as compared to $67.2 million at year ended 2024, representing an investment of $6.9 million for the first quarter of 2025. The Company continues to be carefully efficient and we are currently operating below our anticipated cash investment guidance for the full-year of 2025. Turning now to our full-year 2025 guidance, we reiterate our anticipated full-year 2025 total revenue, operating expenses and cash investment, as well as our ability to fund operations as currently planned into 2027. In addition, we are also announcing guidance for our second quarter of 2025 total revenue, which is expected to be between the range of $17 million and $19 million. This guidance range aligns with our second quarter trends in prior years, excluding stocking orders. The Company is committed to providing guidance numbers that are realistic. Finally, I want to provide some color around potential tariffs that may impact our organization. DANYELZA is manufactured both in the U.S. and outside the U.S. today. We conducted an analysis of our supply-chain to understand the potential exposure to tariffs. At this moment, we anticipate that potential tariff increases would have a minimal impact on Y-mAbs. We are continuing to monitor geopolitical developments as they evolve. With a strong balance sheet and a focused business unit strategy, we believe Y-mAbs is well-positioned to execute our strategic mission and priorities and to support the delivery of multiple anticipated milestones in the year ahead. This concludes the financial update. And now, I’ll turn the call back over to Mike.

Thank you, Pete. Now, let’s open the line for questions. Operator?

Thank you. [Operator Instructions] And the first question comes from Nicole Germino with Truist. Your line is now open.

Good morning, and thanks for taking my question. So, for DANYELZA, can you just help us better understand how to think about the U.S. and Ex-U.S. revenue dynamics and what are the push and pull that get us to the higher-end of the range? Thanks.

Nicole, thank you very much. I’ll turn that over to Doug, and Doug could address the DANYELZA the best.

Yes. So, I’ll tell you, U.S, we continue to see steady growth, I’d say moderate growth with our partners. But, we didn’t have this quarter with some of the stock-ins that we had had previous quarters. So, we continue to see success and growth outside of the U.S., including new starts throughout Asia and The Middle East. In the U.S, we continue to see price increase and slower start to the quarter, but we have seen through the end of the first quarter, into the second quarter an uptick in enrollments and really getting back on track from a revenue standpoint and most specifically around new starts, which is our primary focus. Aside from that, yes, we’re seeing what we’re essentially expecting both in and outside of U.S.

And Nicole, we continue to see the 80/20, 70/30 Rule with U.S., Ex-US, and that continues to, hold true for us.

Okay. Great. And just one quick follow-up, on your competitor in the U.S, do you see any more switching dynamics there? Or can you help us, understand those switching dynamics and how that’s going to evolve for the rest of the year and longer-term?

Yes, Nicole. We continue to try to expand within our current accounts as well as targeting large accounts that we have not penetrated yet. Doug, had mentioned that we’ve got a clinical trial going on that will increase experience within accounts that have not used the product before, and it’s giving us, it’s giving us a tailwind on that side of going after some market share that we haven’t captured in the past.

Great. Thank you so much.

And, the next question will come from Mike Ulz with Morgan Stanley. Your line is open.

Good morning. Thanks for taking the question. Maybe just another one on DANYELZA. Looks like your 2Q revenue guidance does imply a little bit of a downtrend in 2Q over 1Q. You mentioned some sort of historical trends there. Maybe just talk a little bit more about that and how to think about progress in 2Q? Thanks.

Yes, Mike. As we look at this, there is seasonality within the products and we’re forecasting for that. Also as you look at U.S. versus international, very strong start on the Ex-U.S. side in the first quarter. So, as the guidance goes out, I think it’s realistic for us to look at this and factor in both the seasonality as well as the international prevalence pool of patients, where we have treated multiple patients in Q1 that won’t be available in Q2.

Yes. Mike, I’ll add a little bit more texture to your question as well on top of what Mike said. So, if you look at our U.S. sales for last year, in the second quarter, we did $15.2 million. What we’re kind of projecting is kind of the U.S. to be slightly up quarter-on-quarter, year-over-year. Ex-U.S., second quarter 2024, we had a lot of stock-ins. I think that alludes to an earlier comment that was made. If you look at second quarter 2024, we had about almost $5 million of stock-ins in Western Europe, Latin America and Eastern Asia. We don’t anticipate those stock-ins in the second quarter of this year. So, when you kind of do the math on that, that really comes back to a guidance range of $17 million to $19 million. I would stress, Mike, as you can kind of see with first quarter guidance, we’re trying to provide you guys with the next quarter’s guidance every quarter to give you guys a really good understanding and view as to some of the effects of stock and seasonality, various other things, so that we actually can kind of land in the range that we’re projecting. We feel very comfortable. And again, I think as we alluded to in the script, we’re just trying to be realistic about guidance. Coming back to an earlier question, full-year, we still are very convinced with regards to the $75 million to $90 million overall guidance range. We still believe we’re going to land in that zone. Things are looking good for the full-year. I think as we view that the U.S. will start to rebound a bit for us based upon a lot of great work that’s going on in the Company around the business unit realignment and specifically DANYELZA. So, as you guys think about your models, just adjust them accordingly as you think about kind of the second half of the year. Hopefully, that helps, Mike.

Very helpful. Thanks for the additional color.

Yes.

And, the next question comes from Justin Walsh with Jones Trading. Your line is open.

Hi, thanks for taking the question. I’m wondering if you can comment on any current plans for naxitimab in osteosarcoma?

Yes. We continue to, support IISS in osteosarcoma. Also, looking at the potential of developing, a better diagnostic to determine GD2 expression. GD2 is very difficult as you look at the challenges around having an IHC for that. So, we’ve learned a lot in our 1001 trial on the on the SADA GD2. So, with that, I think, we’ll be able to accelerate development with better patient selection in osteosarcoma.

Great. Thanks for taking the question.

Thanks, Justin.

The next question comes from Li Watsek with Cantor. Your line is open.

Hey, good morning. Thanks for taking our questions. Maybe just on CD38-SADA, it looks like you, it was the first patient. Wondering if you can just share some of the details of the Part A in terms of number of patients they want to enroll and dosing regimen there. And then just, in terms of how should we think about the timeline to data, what would be the right benchmark here? So we think, that you might need similar time as you did for GD2 or it might be a little shorter? Thanks.

Yes, Li. Thank you very much for that. We’re going to have a much deeper dive on our Radiopharmaceutical platform on the 28th. But, just to give you a little bit of color, we dosed the first patient. It is a smaller overall subset of patients than we were looking at for our GD2, but it is a very challenging indication in the relapsed/refractory non-Hodgkin’s two recruit patients. That’s why it was a bit challenging in finding the right patients to dose, for us it’s a platform safety study. So, with that, we’re looking at ways to accelerate it. But right now, the plan isn’t around 12 to 15 patients. So, it is less patients than we saw in the 1001 trial.

Thank you.

Thank you, Li.

And, our next question comes from John Newman with Canaccord. Your line is open.

Hi, guys. Thanks for taking my question. Just had kind of a financial question here. Just curious if there’s any effect from a Medicaid reserve perspective this quarter. I know in the past there have been some adjustments, but not sure if there was anything in the first quarter? Thanks.

Yes, John, I appreciate it. I’ll turn that over to Pete, and if he could give you some clarity on that.

Yes, John, great question. As you know, from some prior quarters, we’ve had some adjustments as we’ve gone quarter-on-quarter, especially through the course of 2024. I think what I would say to you is that we’re now starting to see some stabilization in the Medicaid 340B, gross to net elements. So, we don’t anticipate major changes as we go forward kind of in 2025. I know we had some more significant adjustments in 2024 in various quarters. But again, we’re starting to see some stabilization. I think some of that, especially the 340B is associated with a bit more of the revenue shift to outside certain institutions where they actually have patients in in 340B. So, and then on the Medicaid side, again, stabilization. So it’s overall, I think, the answer is 2025, we don’t anticipate any major kind of adjustments at this time. So, okay? Hopefully, that helps.

Thank you. Yes, thank you.

And the next question comes from Jeff Jones with Oppenheimer. Your line is open.

Good morning, guys, and thanks for taking the question. Mike, you mentioned looking at a new construct for GD2-SADA to improve tumor uptake. How does that impact the plan to move forward with the Part B of the study? Can you speak to timing and any other impacts? Thanks.

Hey, Jeff, I appreciate it. Good question. Again, just from a topline perspective, what we’re looking to do is increase the affinity to the receptor as well as the duration that it sits on the tumor, which will improve the overall uptake. There’ll be a bridging study that goes on between where we are today and Part B, just to show the safety and affinity of the new linker. And again, it’s a proprietary linker for us. So, we’ll go into this much deeper on the 28th, but what we plan to do is have that out for in the second half of this year with essentially being completed, probably next year.

Great. Thank you.

Thank you.

And, the next question comes from Bill Maughan with Clear Street. Your line is open.

Hey, good morning and thanks. So, looking beyond quarter-to-quarter dynamics on DANYELZA, obviously, there’s sort of a revamped commercial effort on that. What needs to happen to return to more robust long-term growth and when might we see that tick up? Thanks.

Yes, Bill, I appreciate that. And, that’s the exact reason we went into the key business unit structure and brought in Doug to execute that. So, I’ll turn it over to Doug, and he can share his plans.

Yes. So, thank you. The first thing that we have been focused on and quite frankly the business as a whole has been focused on for last year to 18 months is developing advocates and further developing that advocacy to be more vocal in the market. We’re starting to see that reflected with the change in the NCCN guidelines that are recently announced as well as some of our, KOL development, it starts to really move us back into a position where we are in the clinical discussion when it comes to treating these very sick patients. So, the first thing starts with advocacy. The second piece is developing stronger financial messaging around DANYELZA and specifically around outpatient and the benefits of outpatient treatment in this disease state. And then finally, it’s around global expansion, which we referred to earlier a few different times, but finding the markets where it is preferable and viable for DANYELZA through our partners and where there are growth opportunities. So, we continue to follow that playbook. And again, as I said earlier, we’re starting to see those results, but, it really starts and ends with advocacy. And again, we see that change in the NCCN guidelines as a direct reflection of how we have moved the advocacy needle in our favor.

Thanks. And, just to follow-up with a radiotherapy question. Obviously, initial experience in the clinic is useful, but also thinking through translatability to the rest of the radiotherapy pipeline. Given GD2 is obviously a different target, it’s a different tissue than CD38 and other targets that may be announced in a couple weeks, how translatable are your learning so far on the GD2 program to the rest of the platform? Thank you.

Yes. That’s another good question, Bill, and we’ll definitely get into that in a much deeper way. But, what the changes we’re making and the advances we’re making are platform related. So, as we learn from the GD2 and CD38, you go from an end of one to an end of two and as we add additional products in and looking at our preclinical versus our clinical data, the changes we make will be platform-wide. So, as we move to a proprietary linker chelator that has a higher affinity and duration on the tumor, that will be the new platform moving forward. We started with the naked DOTA as a way to get into patients quickly in a very safe way without having two different variables. So, we’ve isolated the safety on the GD2-SADA and we’re in process on the CD38, now moving into the proprietary linker and chelator, it will be the same linker-chelator combinations by isotope for all of the SADA drugs moving forward. So, we have that opportunity as we learn to apply it back to all of the future constructs.

Great. Thanks.

Thanks, Bill.

And, the next question will come from David Nierengarten with Wedbush. Your line is open.

Hey, thanks. Most of my questions, actually were the previous questions, but I have one more relating to the platform. I know you’ll go into it more, but the, if you’re swapping out the linker to increase, affinity and residence time, I have to ask, like, basically, why did you open up the CD38 NHL, study? Are you going to swap that out too or, kind of, like, walk me through the reasoning there if you’re on track to change out a linker and improve the SADA targeting the residence time? Thanks.

Now, David, good question. As we looked at this, it was important to get in and establish the safety of the protein. So, that doesn’t change. So, the CD38-SADA construct is the same regardless of what linker-chelator combination we’re using. So, the entire purpose of both the 1001 and the 1201 is looking at the overall safety of the SADA platform. And similar to the 1001 with GD2, you want to have as few variables possible. So, maintaining the naked DOTA on the Lutetium gives you that safety information you need from the CD38. So, that when the safety is established as part of the bridging study, for the new chelator-linker that can then be translated back in as an amendment to start looking at that as you advance the product forward for treatment. So again, it’s about establishing the safety of the protein, about the speed of getting that information and then making a change once you have that variable down that you’re confident that there’s no safety signals from the protein itself.

Okay.

Thanks, David.

And, our next question comes from Kemp Dolliver with Brookline Capital Markets. Your line is now open.

Great. Thank you. Are you seeing stabilization in the number of cycles per patient for DANYELZA now?

Kemp, that’s a good question. Doug?

Yes. Stabilization is relevant, but I think overall we see the volumes remain consistent at each individual facility. There are small changes in protocols, but in general, we’ve seen year-over-year growth in number of vials per patient in the U.S. We see similar trends abroad. I think the biggest area of focus for us is less around number of vials per patient. It’s more around, penetrating large accounts that are utilizing a number of anti-GD2 drugs and making sure that DANYELZA has his rightful place in that treatment paradigm. So, while we will continue to support and educate on number and how each individual patient is treated from a number of vial standpoint, our real focus is making sure that the clinically relevant information is in the hands of the decision makers, specifically the clinicians that are treating these patients.

Great. And, just to follow-up on your efforts with DANYELZA, so you have referenced a couple of times the investigator initiated trial of essentially in the COG network. Has that trial initiated and how many sites are involved and how many sites are you trying to get involved?

So, the protocols and the setup of the study is in the hands of the investigator. We’re just supporting them. But, this particular this next study will have multiple COG facilities involved and they are key and I would say luminary facilities amongst that group. So, we’re quite excited about how this study has evolved and developed. We do anticipate a very near-term start. So, hopefully there will be information available to the market in the very near future about the sites and what level of involvement.

Great. Thank you so much.

Thank you, Kemp.

And, our next question will come from Chiara Montironi with Van Lanschot Kempen. Your line is open.

Hello, team. Thanks for taking my question. Congratulations with the progress as well. So, one question for me about, DANYELZA and the inclusion in the NCCN guidelines, but also regarding indeed the new investigator led trial in collaboration with the COG advocacy groups. I was wondering if you could talk a little bit more, how do you see this impacting DANYELZA growth? Do you think that the guidelines will have an impact on shifting the clinician choice versus competitor? And, also if you could repeat again when do you anticipate to, that the investigator will initiate this trial, please? Thank you.

Thank you, Chiara. I’ll turn it over to Doug. He can address the NCCN guidelines as well as the timing on the IISS.

As far as the NCCN guidelines are concerned, we see this as putting us on similar footing with our competition from a recommendation standpoint. Now, the decision making process still exists at the clinician level. Again, back to reiterating where our focus is, is around educating and providing information to clinicians making decisions on a day-in, day-out basis. But, it really removes what was a headwind for some, in certain accounts not being included in the guideline and does provide a potential tailwind for the team and the market as a whole to re-evaluate the placement of DANYELZA in the treatment paradigm. So, while and Pete referenced earlier around moving in guidance, we do anticipate some more open doors for the team to have discussions clinically, and again, kind of rounding into both the clinical and the financial message not related to the guidelines, but just general around treatment with DANYELZA. So, in summary, it most likely removes a headwind and provides potential for some tailwinds now that we are referencing the guidelines. From a timing on the trial, we’ve been consistent with Q2. We’re not changing that timeline. We think we’re a matter more like days than weeks from the start of this. So, we’re quite excited about the start of that and so are the investigators, quite frankly. So, a lot of positive momentum for DANYELZA in the market with some accounts that really don’t have or at least previously hadn’t had significant experience with the product.

I think the other thing is opening up that to multiple sites. We expect enrollment to take place and be completed and the majority of it completed in the remainder of 2025.

Thank you very much.

Thanks, Chiara.

And, our next question comes from Alec Stranahan with Bank of America. Your line is open.

Hey, guys. Thanks for taking our questions. Just a couple from us. First, curious if the Category 2A, designation was expected from your side. Maybe unpack this a bit and how this, stacks up versus other approved options?

Yes. Alec, it’s a great question. As we look at this, the 2A designation for us, I mean, that is expected. And, when you look at it the, it is the level of information. So, these are rare diseases, or ultra-rare diseases with small patient populations and not the widespread data you see with drugs that are in a much larger patient population. So, the 2A is expected and the same as the competitor. So with that, it gives us reassurance that we’re on the same playing field. And also, it’s a high level of confidence from the NCCN panel as well. So, it puts us in a very good position and on a level playing field with competition.

Okay, great. That makes sense. And, maybe just one more sort of higher-level. Any comments on the new appointments at FDA or CBER, any changes in your regulatory interactions or development approach for any of your assets? Thanks.

I’ll reserve the comment on individuals or departments or policy. But, what we find is we have very close working relationships with the FDA and we’re able to get our meeting scheduled, get our documents reviewed. So, I think the entire country is in a wait and see on any changes in new administrations. However, we continue to move forward and there’s a lot of great people in the FDA that we’ve been working with for a long period of time and we continue to have the relationships. So, always a positive outlook on people doing good work in the FDA and responding accordingly and wanting to see patients get treated. So, we feel very good about where we are today and hopefully that continues in the future.

Appreciate the color, and thanks for the questions.

I show no further questions at this time. I would now like to turn the call back to Mike Rossi, for closing remarks.

Great. Thank you everyone for joining us today and discussing our first quarter 2025 results and our continued progress. We believe Y-mAbs is well-positioned to execute and achieve strategic priorities across our DANYELZA and Radiopharmaceutical business units in 2025 and beyond. We look forward to our Radiopharmaceutical pipeline update and our GD2-SADA Phase I Part A data readout on May 28. Look forward to seeing everybody there, and have a great day.

This concludes today’s conference call. Thank you for participating. You may now disconnect.