Y-mAbs Therapeutics, Inc.

Good morning, and welcome to YMAP's Therapeutics, Inc.' 's earnings conference call for the fourth quarter and full year 2024. At this time, all participants are in 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 like to hand the call over to YMAP's head of IR, Courtney Dugan.

Thank you, Operator, and good morning, everyone. Welcome to the YMAB's fourth quarter and full year 2024 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 unit 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 31st, 2024, 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 to the closest GAAP financial measure is included in today's press release and 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 Chief Executive Officer, Mike Rossi.

Thank you, Courtney. Good morning, and thank you for joining us. I have with me today our Danielsa Business Unit Head, Doug Gentilcore, who joined us recently in January, our Radio Pharmaceutical Business Unit Head, Natalie Tucker, and our Chief Financial Officer, This morning, I will begin by reviewing key highlights across our business from the fourth quarter and full year 2024. Next, Doug will provide details on our global Danielsa sales performance and strategy moving forward. Natalie will then provide an overview on the recent updates around our SADA pre-targeted radiopharmaceutical platform. and reiterate expectations around our anticipated GD2 SADA phase one data update planned for the second quarter of this year. Then Pete will review our fourth quarter and full year 2024 financial performance, our cash resources, and provide our first quarter and full year 2025 guidance before we open our line for Q&A. Let's begin by looking at our key achievements in 2024. I'm proud of what our team achieved across our business in 2024. We did what we set out to do, and there is more work to be done. Danielsa has kept a steady share of the anti-GD2 market in the U.S. of between 15% and 17%. And importantly, we achieved total revenue inclusive of Danielsa net product revenues and license revenues of $87.7 million U.S. for the full year 2024 which is within our stated guidance range of between 87 and 95 million. We continue to face headwinds from competition for patients, including with Naxidimab trials, and Danielle's growth continued. We successfully expanded XUS through several partnerships, and vial demand remains strong. Looking at our radiopharmaceutical platform, We achieved proof of concept with our SADA PRIT platform as demonstrated by preliminary Part A data from our GD2 SADA Phase 1 trial, Trial 1001. We look forward to sharing a more complete data readout anticipated in the second quarter of the year, which will include a number of endpoints and biomarkers that we have previously highlighted. Regarding our CD38 SADA Phase 1 trial, Trial 1201, We have activated five sites to date and are actively working to dose our first patient. From a financial standpoint, we end at 2024 with $67.7 million US in cash and cash equivalents, which reflects $11.4 million in total annual cash investment for the year below our stated guidance. We anticipate that our cash and cash equivalents will continue to support our current plans into 2027. Let's now turn to our recently announced business realignment strategy. On January 10th, we announced our strategic decision to establish two distinct business units, Danielza and our radio pharmaceuticals business unit, through which we will manage and operate our business. This is an effort to accelerate the development of our novel SADA print platform and high-value targets program and maximize the potential of Danielza. This April will mark our 10-year anniversary since YMABS was founded by Thomas Gadd. The company's mission from day one was to bring important new cancer therapies to patients as quickly as possible. The company has done a tremendous job since then of positively impacting countless lives around the world with our leading anti-GD2 therapy, Danielza. Through our recently executed realignment, we expect to expand our radiopharmaceutical capabilities, accelerate clinical execution, further improve capital efficiencies, and better align strategic priorities. With this and other changes undertaken in 2024, the majority of our senior leadership team is now based in the U.S., right here in Princeton, New Jersey. In addition, we are in the process of moving some roles from Denmark to the U.S. to more efficiently coordinate the advancement of our PRIT platform and implementing a small adjustment to Danielle's commercial team to focus the team on potential growth opportunities within the anti-GD2 markets. Again, I'm proud of our team's achievements in 2024 and thankful for the dedication of each member of our organization to the mission of bringing important new therapies to patients. We remain staunchly committed to advancing a potential new generation of therapies through clinical development aimed at improving outcomes and long-term quality of life for patients and their families. I will now pass the call over to Doug Gentilcore, to provide further color on Danielsa sales for the fourth quarter of 2024.

Thank you, Mike, and good morning, everyone. I joined YMABS in January as the head of our Danielsa business unit. I have 21 years of experience in biotech, focused predominantly on commercial and strategic operations in radiopharmaceuticals and the pediatric rare disease space. Prior to joining YMABS, I served as chief commercial officer and then CEO of Artemis, which was acquired by Telex Pharmaceuticals. Although I've only been at YMAS for two months, I've seen a level of passion and commitment across our team that is unmatched. I'm thrilled to be leading the Danielza business unit. As the only approved anti-GD2 therapy for high-risk relapsed refractory neuroblastoma and bone and or bone marrow, Danielza is a differentiated therapy with proven clinical benefits. We believe we have an opportunity to penetrate the U.S. market even further and increase physician utilization in our current indication while supporting our investigator sponsors on their trials to advance Danielza into potential new indications. Let's take a look at some commercial highlights in the fourth quarter of 2024. We are pleased to have achieved our full year total revenue guidance of $87.7 million and Danielza net product revenues of $85.2 million. In the fourth quarter of 2024, Total Danielsa net product revenues were $24.5 million, representing a 5% increase compared to the same period in 2023, primarily driven by strong international markets, including the favorable impact of an inventory stocking order in China. While we encountered continued competition in the U.S. from both the launch of a new market entrant for maintenance therapy, as well as ongoing third-party sponsored clinical trial activity, we still saw increases in key performance indicators. As of December 31, 2024, a total of 69 accounts have ordered Danielza around the U.S. since its initial launch in 2021, with 11 accounts added in 2024. Danielza's estimated total share of the U.S. anti-GD2 market has remained steady at between 15% and 17%. Our dedicated team continues to receive positive healthcare provider feedback on Danielza through ongoing customer interactions, and we are continuing to build strong relationships with KOLs and key advocates. In the year, we saw continued institutional adoption of Danielza, which was added to seven hospital formularies in 2024, bringing the total since initial launch to 48 hospital formularies as of December 31st, 2024. The newly realigned business unit structure will allow the Danielsa team to focus solely on the upper trajectory of the product. The commercial team will focus on promotion and the rightful positioning of Danielsa. Along with what we would deem as typical promotional activity, we will further develop meaningful advocacy amongst thought leaders, which is critical to the future of Danielsa. At the same time, the medical team will prioritize education, new site startup, and produce new and impactful data for Danielsa. We've already seen the fruits of these efforts with new sites coming online in 2025, as well as a number of ISS trials that will kick off this year. Now, let's turn to our commercial progress outside of the U.S. Ex-U.S., our fourth quarter 2024 Daniela Net product revenues were $7.7 million, an increase of 78% compared to the fourth quarter of 2023. The increase in international Danielsa net product revenues was driven by the launch of our named patient program in Western Asia in 2024, and increased net product sales in both Eastern Asia and Latin America, which was partially offset by a decrease in our named patient program in Western Europe. The fourth quarter marked Danielsa's highest sales in Western Asia, particularly in Turkey with our partner Infarmis. And the third consecutive quarter of Danielsa's sales in Brazil and Mexico led by our Latin American partner, Adium. We expect to see additional adoption over the coming quarters and look forward to providing further updates as we learn about market dynamics in these regions. In China, our partner Cyclone continues to expand use of Danielza and is gearing up to launch Danielza in Hong Kong following its approval in the region last quarter. Our sales in the quarter benefited from an inventory stocking order related to the relabeling of Danielza in China. I'm excited to be working with this terrific Danielza team and energized to advance our goals in 2025 and beyond. Danielza is critical therapy for patients with high-risk relapse refractory neuroblastoma in the bone and or bone marrow, and we are committed to further expanding its global reach and advancing into new potential indications. I will now pass the call to Natalie.

Thank you, Doug, and hello, everyone. I joined YMABS in May of 2023 as Vice President of Business Development and Chief of Staff to the CEO before being appointed to our Head of the Radio Pharmaceuticals Business Unit earlier this year. My background includes extensive pharmaceutical strategy and operational execution experience with specialized experience in radio pharmaceuticals. Previously, I served as Executive Director and Head of Business Planning and Strategy for Novartis' Radioligand Therapy Business Unit and held leadership roles at GuideHealth, a global consultancy where I focused on commercial launch strategies for biotech and pharmaceutical companies. I'm excited to lead the advancement of our innovative, pre-targeted theranostic platform and clinical programs. Today, I will provide a recap of our current SATA print programs and what to expect for our pipeline update in the second quarter of this year. Let's start with a brief overview and update on our GD2-SATA Phase 1 trial, Trial 1001. As a reminder, the primary objective of Trial 1001 is to evaluate the safety and tolerability of GD2-SATA in adult patients with solid tumors, including small cell lung cancer, sarcomas, malignant melanomas, and neuroblastoma. In part A, we first explored variable protein doses of 0.3, 1, and 3 megs per kilogram, and a pre-targeting interval of two to five days. As of February 26th, we've seen seven sites open and dosed a total of 22 patients with both the SADA protein and the diagnostic lutecin payload. Of those 22 patients, Nine patients had positive GD2 expression and were eligible for the therapeutic phase of the study to receive up to 200 millicuries of lutetium. The initial blood pharmacokinetics profile of these patients' dose with the SATA protein appears to match our preclinical models in terms of clearance data, and the blood PK profiles from patients are comparable and supportive of the current dose interval between two and five days. We continue to be encouraged with what we've seen so far. To date, there have been no dose-limiting toxicities and no instances of any treatment-related serious adverse events. Based on the SPECT CT scans and PK activity we've seen thus far, we believe we've achieved the validity of our SATA PRIT platform, demonstrating that GD2-SATA can both target and bind to tumors and is well-tolerated by patients. It is important to note that these early data are still part of an ongoing trial and are not necessarily indicative of the full results or ultimate success of the trial or the SATA development program. As you saw from our update in January, we expect to present a more complete data set from Part A of Trial 1001 in the second quarter of this year, including additional scanned images and PK data. Our second SATA print platform, PD38-SATA, is in a Phase I trial for the treatment of non-Hodgkin's lymphoma, focusing on B and T-cell lymphoma. We've selected the first six sites, with five sites activated to date. Two of those sites have been activated since our third quarter update. We plan to accelerate recruitment activities and expect to see the impact of those initiatives in the coming months. Now, let's turn to what we expect from our pipeline update in the second quarter of this year. In addition to our more complete data set from Part A of Trial 1001, we expect to present additional platform optimization data that will inform the further advancement of our current programs and new clinical programs going forward. In addition, we plan to present our PRIT pipeline expansion roadmap and timeline. Our team has conducted target selection work in the second half of 2024, evaluating the next potential high-value targets. We started with a database of over 1,200 targets and narrowed that down to between 40 and 50 fully characterized targets. Key considerations for target selection included disease state characteristics, such as unmet need based on a five-year OS of less than 70%, indication size greater than 5,000 annual incidents, and tumors that are known to have radiation sensitivity. Secondly, we looked at target-specific attributes, such as cellular location, tumor expression, and healthy tissue expression. Lastly, we force-ranked these targets to develop a mix of archetypes that we believe will diversify our development risk across novel, high-value targets, high-risk, high-reward targets, well-validated targets, and lastly, proof-of-concept known targets. In the second quarter of this year, we anticipate unveiling these new print targets for development. I'm excited to be leading the radiopharmaceutical business unit and continuing to work alongside this fantastic team of industry experts. We believe a therapeutic pre-targeted approach is a potential game-changing platform in the radiopharmaceutical space with potential beyond oncology. We look forward to providing more details around our future plans during our second quarter pipeline update. Now, let me hand the call over to Pete.

Thank you, Natalie, and good morning, everyone. As you heard earlier, we recorded total Daniels and net product revenues of 24.5 million in the fourth quarter of 2024, representing a 5% increase compared to 23.4 million total Daniels and net product revenues in the fourth quarter of 2023. This was primarily driven by an increase in international revenues that was partially offset by a decrease in U.S. revenues. U.S. Daniels and net product revenues were $16.8 million and $19.1 million. For the three months ended December 31st, 2024 and 2023, respectively, representing a 12% decline. The decline was primarily due to an unfavorable price mix, which was partially offset by a 1% increase in U.S. volume for the fourth quarter 2024 compared to the fourth quarter 2023. Ex-U.S. net product revenues were $7.7 million and $4.3 million, where the three months ended December 31, 2024 and 2023, respectively, representing a 78% increase. The increase in international Danielza net product revenues was driven by named patient program launch in Western Asia, and in 2024, an increase in net product sales in Eastern Asia and Latin America. This was primarily offset by a decrease in sales in Western Europe. Our total Danielson net product revenues of 85.2 million for the year ended December 31st, 2024 were relatively flat compared to net product revenues of 84.3 million for the year ended December 31st, 2023. We recorded 2 million of licensing revenue for the three months ended December 31st, 2024 from Noble Farm. And we reported 2.5 million of licensing revenue in the year ended December 31st, 2024. We did not have licensing revenue for the three months ended December 31st, 2023. And we reported 0.5 million of licensing revenue for the full year ended December 31st. 2023. Research and development expenses were $12.2 million and $13.4 million, with the quarter ended December 31, 2024 and 2023 respectively. Our research and development expenses were $49 million, with the year ended December 31, 2024, representing a decrease of $5.2 million from 54.2 million for the year ended December 31st, 2023. The decrease in research and development expenses was primarily attributable to the recognition of 4.1 million of milestone and licensing acquisition costs related to our SADA licensing agreement during the year ended December 31st, 2023. Selling in general administrative expenses increased 1.2 million and $9.8 million to $12.4 million and $54.6 million for the quarter and year-ended December 31, 2024, respectively, compared to the same periods in 2023. The increase in SG&A for the three months ended December 31, 2024, was primarily attributable to $0.5 million increase in personnel costs inclusive of stock-based compensation and $8.6 million restructuring charge related to personnel and stock-based compensation costs associated with our business realignment. The increase in SG&A for the year ended December 31st, 2024 was primarily attributable to a net impact of $3.8 million related to the legal settlements and year ended December 31st, 2024 The increase also includes a $1.2 million related to separation and consulting agreements with former executives and $2.2 million increase in personnel costs associated with stock-based compensation. We reported a net loss for the fourth quarter ended December 31st, 2024 of $6.8 million for a negative 15 cents per basic and diluted chair. as compared to a net loss of one million or negative two cents per basic and diluted chair for the quarter ended December 31st, 2023. In addition, we have reported net loss for the year ended December 31st, 2024 of 29.7 million or negative 67 cents per basic and diluted chair as compared to a net loss of 21.4 million or a negative 49 cents per basic and diluted share for the year ended December 31st, 2023. The increase in net loss for the quarter and year ended December 31st, 2024 was primarily driven by an increase in operating expenses and an unfavorable impact from foreign currency transactions, partially offset by an increase in net product revenues. As mentioned earlier, We ended the fourth quarter of 2024 with cash and cash equivalents of 67.2 million as compared to 78.6 million at the year ended 2023, representing a decrease of 11.4 million. Importantly, we continue to maintain a strong balance sheet, reporting 0.9 million cash outflows for the fourth quarter 2024. Turning now to our full year 2025 guidance, we are announcing our anticipated full year 2025 total net revenue to be in a range of between $75 million and $90 million. As a reminder, historically, YMABS has provided total operating expenses, which include cost of goods sold. Consistent with that approach, our anticipated total net operating expenses including cost of goods, is expected to be between $129 million and $134 million for the full year 2025. Excluding cost of goods sold, our total net operating expenses is expected to be between $116 and $121 million for the full year 2025. We expect total annual cash investments for full year 2025 be in a range of between 25 million and 30 million. In addition, we are also announcing guidance for our first quarter 2025 total net revenue, which will be between a range of 18 and 21 million dollars. As we prepared our guidance for 2025, we noted there is a fair amount of variation in consensus estimates across our guidance numbers. The company is committed to providing guidance numbers that are realistic. With a strong balance sheet and a focused business unit strategy, we believe YMABS is well positioned to execute on our strategic mission and priorities and to support the delivery of multiple anticipated milestones in the year ahead. This concludes the financial update, and I will now turn the call back over to Mike. Thank you for that overview, Pete.

Let's now open the line for questions. Operator?

Thank you. If you'd like to ask a question, please press Star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press Star 1-1 again. We ask that you please limit yourself to one question and one follow-up. Our first question comes from Alex Stranahan with Bank of America. Your line is open.

Hey, guys. Thanks for taking our questions and appreciate, you know, all the updates as we start the year here. Maybe first, just on Danielza, given the one cue in full year 2025 revenue guidance, should we be thinking about a roughly flat trajectory for the most part? Or could there, you know, maybe be some ups and downs to account for seasonal impacts or other factors throughout the year?

Yeah, Alex, thanks for the question. As we look at... 2025, we put our plans in place to accelerate our growth. It's going to take a little bit of ramping up through 2025 as we're supporting some clinical trials and looking for some additional penetration within the high-risk relapsed refractory neuroblastoma market and also looking for other opportunities to expand the product. But I'll turn it over to Pete on the guidance for the quarter as well as the year.

Yeah, Alex. Appreciate the question. So first off, just want to remind everybody that we actually did provide kind of preliminary unaudited numbers at the beginning of this year for 2024. We hit those numbers based upon the revised guidance that we put out last year in Q2 of 2020. Our guidance to be realistic and credible. So I think part and parcel to us putting out both full year numbers for this year for 2025 as well as the first quarter numbers is to make sure that we really guide the street as to some of those effects that you alluded to like seasonality and some of the stocking effects that we've seen in the past with regards to some of our ex-US partners. So to that note, we were very clear the guidance for the full year is quite wide range. I'll be the first to admit that. But again, I don't think we want to reset numbers for the full year later this year. So I think the way you should think about is kind of think about the midpoint within that range as you guys model out this year on a full year basis. And then separately for the first quarter, stick within the guidance range that we laid out for you guys, which was that $18 to $21 million number on the revenue side of the equation. Obviously, we're two months already into the first quarter. We're seeing already the results of that quarter, so we feel pretty good about that guidance range, and we're going to stick to that. And as we move forward in future quarters, it is our intent as a company to provide the next quarter update. So, for instance, at the first quarter earnings call, we will provide you guidance with regards to the second quarter, and then we'll also update the full year number, and we're going to narrow the range as we move through the year. So hopefully that's very helpful for you guys as analysts, and it'll also allow us to kind of march to numbers that are achievable for the company as we move down through the year. Hopefully that helps, Alex.

Yeah, no, that's very helpful. And maybe just one quick one, thinking about the upcoming SADA update, as you're measuring tissue concentration in the upcoming readout, which tissues do you think will be most important you know, outside the tumor from a dose selection perspective. Thank you.

Yeah, Alex, I think as we look at this, anytime you look at radiopharmaceuticals, you know, aside from the tumor itself, you're looking at potentially three areas where it would concentrate and remain, one being the kidneys. So the renal elimination of products would be an area that you look at as something that could potentially be dose-limiting. The second would be hepatic elimination, so what you would have in liver. And then finally, if you see additional bone marrow uptake. Bone marrow is another area that you look at for increased concentrations. I think one of the big things, too, with radiopharmaceuticals, if you look at this, as you move into the PET emitting agents, you can really see all of the places that it goes. And you see that with the PSMA product that's out in the market today, where you see additional salivary and lacrimal gland uptake. But outside of that, I think one of the big keys is not just how much is passing through through elimination, but what are the effects of that? So you'd look actually at the labs to see if there's any either acute renal injury or chronic. Same thing, you start looking at liver enzymes to determine if you're actually having an impact. Because systemic radiotherapy at these relatively small doses compared to external beam therapy has different impacts on the body. So it's really, you know, are you seeing injury from it versus just concentration?

Got it. Thanks for the question. Appreciate it all.

Thank you. Our next question comes from Mike Oles with Morgan Stanley. Your line is open.

Good morning, and thanks for taking the question. Maybe just another sort of guidance question, particularly on OPEX. you're guiding to 116 to 121 million this year. Just wondering if you can give us the breakdown between R&D and SG&A. And then as we move forward into sort of the outer years, as you start to ramp the SADA program, how should we think about R&D evolving there? Thanks.

Yeah, Mike, I appreciate it. As we look at this, there'll be a couple of things. I'll turn it over to Pete for some of the breakdowns. But as we think about our investments, that's also into our planning for our cash runway. And as we look in at bringing additional targets in, so there'll be some costs coming out of Danielsa on our 201 study as that's coming to a completion, which was our post-marketing commitment. We also have additional targets coming in to R&D from a SADA perspective. But we've also optimized that system, and we're treating it a little bit differently on how we bring targets into our preclinical and phase one than has been done in the past. So we'll be sharing that process in second quarter on how we plan to decrease the cost to get these targets into clinic and how many targets we can actually bring forward. But I'll send it over to Pete for what our actual spend is and breakdown.

Sure. Thanks, Mike. Mike, good question. So just to clarify, the 116 to 121 is our OPEX guidance number without cost of goods. Just as a reminder for everybody on the line, in the past, we've provided OPEX guidance historically as a company, including cost of goods sold. Again, as a reminder, we said on today's call that including cost of goods, that number is more like 129 to 134. Coming back to the 116 to 121 without cost of goods, the way I would think about the breakdown of that, Mike, and we don't provide specific detail of the breakdown, is think about our SG&A kind of cost for 2024 as reported. So that number was about $54, $55 million. But remember in that number there was about $9 million of some one-time charges in there. related to some legal settlements as well as a number of other kind of things. And that was disclosed as part of our overall number. So we don't anticipate some of those one-time items reoccurring in 2025. I would presume take the 55 minus the 9. That's a base. That base will grow a little bit, but not a lot. And then the rest is kind of R&D. So that's kind of the way I would suggest you think about it as you model your numbers. Hopefully that helps, Mike.

Very helpful. Thank you. Yep.

Thank you. Our next question comes from Jeff Jones with Oppenheimer. Your line is open.

Good morning, guys. Thanks for taking the question. As we think about the shift in R&D spend over time away from Danielsa, can you speak a little bit to how you're thinking about the investigator-sponsored studies and investment you are making in Danielsa and how we could look at that impacting revenue looking forward, say, beyond the 2025 guidance? Yeah, Jeff, I appreciate the question.

I think one of the things as we look at Danielza, currently our highest cost associated with the R&D with Danielza is on completing our 201 trial, so the post-marketing commitment. When we look at investigator-sponsored trials, We are continuing to invest in those, which would lead to increased penetration within the segment as well as additional indications. And we'll continue to support that. It does create some short-term competition for patients. However, I think long-term will provide some additional tailwinds. We're also developing a diagnostic to better select for GD2. And with that, as we move forward and have a better way to select, it'll open up the opportunity again to look at potential registration trials for expanded indications on the product. So we know one of the challenges with GD2 as we look at things like osteosarcoma are actually being able to patient select for GD2. And the closer we get to that, the more opportunity it gives us to get into some additional investment in trials, both in ISS as well as potential registration trials.

Appreciate that, Mike. And just one follow-up on the CD38 program. You noted that those trial sites have been open for a while, but you're still working to enroll the first patient. Just any color there on the challenges enrolling that study and how that might, you know, if that is related to the SADA program or the target or something else?

Yeah, no, I appreciate that. It's taken a while to get these five sites up and running. We had one up and running in third quarter, and then we brought the rest of them on since. I'll say it is a very difficult segment to enroll patients. So I think that's been our biggest challenge. We've identified patients, but through the qualification process, either they didn't qualify for the trial or they weren't healthy enough. because it was very much end stage. So, you know, it is a very difficult segment, unrelated to SADA, more related to the refractory non-Hodgkin's patients that have been the challenge. Okay.

Appreciate it, guys. Thank you.

Thank you. Our next question comes from Nicole Germino with Truist. Your line is open.

Good morning, and thanks for taking my question. Just a quick question on the bridging study. So does the bridge to 1001 Part B push out the start to advancing of Part B? And can you remind us again what the timelines and expectations are for Part B and C?

Sure, Nicole. I appreciate the question. I'm going to turn it over to Natalie, who can speak a little bit to, you know, what the bridging study is, why, and kind of what the timelines are for that.

Thanks, Mike. And thanks, Nicole. So just regarding the bridging study back to 1001 part B, we anticipate kicking that off in early 26, and we think it'll be quite quick, especially compared to part A of the study, because we are enrolling a fewer number of patients, and we're really just testing that molecule optimization and the work that's currently ongoing. So we will be reporting on that in Q2 and our plans to go back into Part B in our Q2 data readout with the full targeting plan and strategy going forward. But all in all, it will be what we believe a relatively quick bridge to bring us back into the Part B dose escalation phase.

Great. And then also on the second part of the question, can you remind us about the timelines and expectations for Part B and 2?

Yeah, I mean, Part B is 12, anticipated 12 patients relative to the 24, 23, excuse me, that were consented for the Part A. So, the timeline on that we'd expect to be quite a bit quicker, roughly. I mean, let's just go with quite a bit quicker, including the fact that we will have and we anticipate having pet-directed patient selection. So, Part B In terms of the timeline, we'll be relatively quick to Part A, and then Part C, we will announce once we see a little bit more data in the Part B, and we go back to FDA on detailed timelines.

But compared to Part A, we'll be relatively quick.

Okay, great. Thank you so much.

Thanks, Nicole. Thanks, Nicole.

Thank you. Our next question comes from Lee Watzek with Cantor Fitzgerald. Your line is open.

Hey, good morning. Thanks for taking the question. I guess for GD2-SELDA, the main steps for you to select the protein dose from the Part A, and then just curious for the non-GD2-positive patients, whether patients receive more than one dose of the therapeutic lutetia.

So, appreciate it, Leigh. All nine of those patients that showed uptake did receive a therapeutic level follow-up dose, and that was per the protocol. So when we evaluated those, only those patients that showed significant uptake as part of that diagnostic received a therapeutic. It is limited in the amount of information around the protein dose itself, but we feel confident in the work we're doing currently. that we'll be able to narrow it down to what we think is an optimal protein dose as we move forward into advancing the trial.

Okay. And you also mentioned that you'll be looking at, I guess, a number of different, you know, SAUDAT targets. So, just curious what your BD strategy might be, I guess, for some of them, given it might not be realistic to develop all of them.

Yeah, no, that's a good question. So as we looked at these targets, and we started with over 1,200 targets, we narrowed them down to the top 40 or 50 that we think would be optimal for the radioimmune therapy platform. So with that, we also identified three franchise areas in which we would be interested in bringing those targets to commercialization ourselves. Several of those targets fall outside of those three franchises. more ideal targets to partner with or out-license while the targets that we're looking to bring forward within our franchises would be the ones we would keep in-house. So we're open to BD opportunities. There's also the opportunity if an external partner wanted to bring their target forward to us and for a potential partnership, we would be willing to have that discussion as well. But our commercialization strategy will be focused within our franchises, and that will be part of our second quarter update.

Okay, thank you.

Thank you. Our next question comes from Bill Morgan with Clear Street. Your line is open.

Hey, good morning and thanks. So looking at 2025 Daniela guidance and the references to an updated and increasingly competitive strategy, well, competitive dynamic for Danielsa. Could you help sort of bring to life what that evolving competitive dynamic looks like and kind of discuss that in context of how we should be looking at long-term Danielsa growth? Thank you.

Sure, absolutely. As we look at this, you know, one of the things we look at overall is the competition for the patients, right? So, Ultimately, there's several areas in which you compete for patients, and that is competitive therapies. That is other products that have come to market, as well as clinical trials. So that really falls into the overall competitive dynamics for the product. But Doug has a plan to move forward on how to, A, leverage those clinical trials to make sure we're gaining experience out in the market. and increasing market share and penetration. But we continue to invest, and our goal is to bring it to as many patients as possible. And we're very confident in the product. Doug, do you want to add some color to that?

Yeah. Most of the impact in the near term is transient, meaning that we're competing for some study doses. But that is really laying the groundwork for what's going to come in the future. The good news from a market standpoint, above and beyond, those trial doses and competing for patients, as Mike mentioned, there's plenty of market to move. And we're seeing that happen already early in 2025 with new patient starts and extremely positive feedback from the lead investigator for the ISS, but also the market as a whole.

And Bill, as we go forward, we, you know, we look at the opportunity to expand the outpatient option for parents and for children that are being treated and You know, with Danielle's having the only indication in bone and bone marrow involvement as well as outpatient gives us a lot of opportunity to increase the experience at institutions and increase the outpatient option for parents.

Got it. Thank you. Thanks, Bill.

Thank you. Our next question comes from Justin Walsh with Jones Trading. Your line is open.

Hi. Thanks for taking the question. Now that you're moving forward in the clinic with CD38 SADA, it would be great if you could discuss the unmet need there and what level of benefit patients would ultimately need to see for the asset to prove clinically useful and commercially viable.

Yes, Justin, I appreciate it. You know, coming forward with the CD38, I'll say that the decision was made a few years ago to bring that forward based on internal knowledge. of the CD38 target with the work some of the team members had done in the past to bring in anybody to market. For us, you know, there is an unmet need in non-Hodgkins, but again, it's a very competitive space. So part of bringing CD38 forward was to validate a second target that we can get into clinic rather quickly, which the team was able to do. Patient selecting is much more difficult, but also looking at validating this in a a circulating tumor versus just a solid tumor was an opportunity to get an N of two. So two different targets, start comparing some of the data that we're seeing. You know, time will tell if this develops on how long or how much effort we could give it. But, you know, that'll be up to Natalie and the team as we look forward to our Q2 update on what the targets are.

Got it. Thanks for taking the question. Appreciate it, Justin.

Thank you. Our next question comes from Robert Burns with HC Wainwright. Your line is open.

Hey, guys. Thanks for taking my questions. We're really looking forward to the update coming in 2Q. Just two questions from me, if I may. I guess around the first one, could you provide a little more granular color around the market dynamics in neuroblastoma, especially with the FDA approval of DFMO in late 2023 and how that could potentially be impacting Danielle's assailants? And then the second question is just around the COGS. Obviously, the COGS were significantly higher this quarter, so just some color around that.

Yeah, so I'll start with the entrant of the FMO. You know, when you look at an inhibitor coming into the market, there's always an opportunity for patients to try out a new therapy, but we know with inhibitors it's very limiting to how long that Once the patient begins to advance, they'll need to go back to a more aggressive therapy because, again, inhibitors tend to be a temporary solution. For us, it's always positive when a child can maintain response as long as possible. But as the patients begin to come off of that, they'll need to come back to an anti-GD2 therapy in order to be treated. So I think some of that is an additional headwind that'll return to a little bit of an equilibrium. And, you know, but again, there's options for patients, there's options for parents. And as we move forward, you know, you hope that the best options are what's helping the patient maintain a complete response to prevent the disease from recurring. From a cost of goods perspective, there's ebbs and flows in that. So as we look at bringing product in, There'll be batch costs that come in at different points in time. So what you'll see is an increase as we're doing certain number of batches, whether it's a Daniela cost of goods or whether it's Asada. I can turn it over to Pete for a little bit additional color on what drives those cost of goods fluctuations. But this is a low volume, high value product. So you will see similar to stock ends in the ex-U.S. market. You'll see buy-ins from us as we're getting in from our higher partners.

Yeah, Mike, it's spot on. So you can take a look at the fourth quarter results numbers. The ex-U.S. component was quite strong. And a component of that is obviously continued stock ends and other elements associated with that. That's what drives kind of that COGS component. But then also in addition to that, In the fourth quarter, we did have some inventory write-offs, but that was a minor component of that. We really haven't had a history of kind of write-offs in the past. So, of course, all those things factor into some of those numbers, but hopefully that helps.

Yeah, it certainly does. Thank you for that. Great. Thank you, Robert.

Thank you. Our next question comes from Kemp Dolliver with Brookline Capital Markets. Your line is open.

Great. Thank you for allowing the question. So with regard to the guidance range, can you speak to the dynamics with regard to patients recycling back from DFMO? Also, is there any change in the payer mix that we've seen the last two quarters that's going to carry through, particularly in the first half? And then also, WAC, because it looks like at least with your main competitor, Unitax, they've become very aggressive with increases in WAC. Thank you.

Yeah, I can't, but I appreciate it. The, you know, just a few things as we start looking at this, we look at the overall patient population availability and we build our models accordingly. So, with those that may be cycling on and off of another therapy, we factor those in. We also factor in the residence time that they would be on our therapy versus a competitive therapy. And I'll let Pete speak a little bit more to the payer mix as well as WAC and what that looks like overall. You know, we really don't speak to the competitive products and what they do, but we can really speak to what we have done and how we see our product.

Yeah, Kemp. So first off, from a WAC perspective, pricing perspective, and this is public data, we took a 7% price increase this year. Our competitors tend to take a much higher price increase. I'll just leave it at that. I'm not going to get into details on that. You can go out and take a look at what those numbers are. We obviously do a very thorough analysis as to where our base price is. With those price increases, what the implication is relative to our payer mix, which I think was your other question, because obviously there's a component of payer mix that includes Medicaid, as well as 340B, as well as non-Medicaid, non-340B. And that all folds into those elements. And so when we look at price increases, we do that work with an external third-party service provider just to make sure that we don't overstep price increases and then end up in a situation where we have further givebacks on the other side of the equation. I think with regards to the mix, the mix has continued to move more towards Medicaid. um institutions uh in terms of sales as we've kind of moved through the last kind of five quarters year and a half two years uh as we've kind of migrated in that direction of course that is had some impact with regards to overall uh gross margin to the business um but we see stabilization at this juncture most probably as we move forward so we did have a slight increase in this quarter Over last quarter, we had an increase, as you know. But I think as we move forward in 2025, we're most probably at that kind of peak point where you should see stabilization in that number. So hopefully that helps jump on both fronts.

Yeah, that's great. Thank you. My second question relates to your efforts to engage with COG sites. And if you could just give a little more detail behind that.

Yeah, Kemp, I appreciate it. So when we look at this, you know, we know the competitive product was brought to the market through COG. So it's taken a little bit, well, it's taken a lot of effort to penetrate those COG sites and bring the benefits of Daniels forward. We have clinical trials, both ongoing as well as scheduled, to kick off with some leading COG sites as they look at giving Danielle's as an option across multiple sites. So for us, we're still focused on their top 10 to 15 sites to continue to penetrate and increase penetration, as well as provide that outpatient option. So we're working very closely with the key opinion leaders there. We are known as a company focused on GD2, and we have very good relationships and continue to build those, as well as build experience within the COG sites.

Thank you. There are no further questions at this time. I will now hand the call back to Mike Rossi for closing remarks.

Thank you, Operator, and thank you, everyone, for joining us today to discuss our fourth quarter and full year 24 results and our continued progress. We believe YMABS is well-positioned to execute and achieve strong strategic priorities across our Danielsa and Radio Pharmaceutical business units in 2025 and beyond. We look forward to providing further updates during our radio pharmaceutical pipeline update and GD2 SADA Phase 1 Part 8 data readout planned for second quarter. Thank you all and have a great day.

Thank you for your participation. This does conclude the program. You may now disconnect.