Y-mAbs Therapeutics, Inc. Price & Performance (YMAB)

Thank you, operator, and good morning, everyone. Welcome to the YMab's Fourth Quarter and Full Year twenty twenty four 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 Web site. [indiscernible] Let me quickly remind you that the following discussion contains certain statements that are considered forward looking statements as defined the Private Securities Litigation Reform Act of 1995. [indiscernible] 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 ks for the year ended December 31, 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. [indiscernible] 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 are Daniella's Business Unit Head, Doug Genelcore joined us recently in January our Radiopharmaceutical Business Unit Head, Natalie Tucker and our Chief Financial Officer, Pete Frimshell. This morning, I will begin by reviewing key highlights across our business from the fourth quarter and full year 2024. [indiscernible] Next, Doug will provide details on our global Danielle's sales performance and strategy moving forward. Natalie will then provide an overview on the recent updates around our SADA CRIT pre targeted radiopharmaceutical platform, [indiscernible] 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 and 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. Danielle's has kept a steady share of the anti GD2 market in The U. S. Of between 1517%. [indiscernible] importantly, we achieved total revenue inclusive of Danielle's net product revenues and license revenues of $87,700,000 for the full year 2024 and which is within our stated guidance range of between $87,000,000 and $95,000,000 We continue to face headwinds from competition for patients, including with naxitimab trials and Danielle's growth continued.

We successfully expanded ex U. S. Through several partnerships and bile demand remains strong. Looking at our radiopharmaceutical platform, we achieved proof of concept with our SATA PRIT platform as demonstrated by preliminary Part A data from our GD2 SADA Phase one trial [indiscernible] 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 one trial, trial twelve oh one, we have activated five sites to date and are actively working to dose our first patient From a financial standpoint, we ended 2024 with $67,700,000 U. S. In cash and cash equivalents which reflects $11,400,000 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 10, we announced our strategic decision to establish two distinct business units. [indiscernible] in our radiopharmaceuticals business unit through which we will manage and operate our business. This is an effort to accelerate the development of our novel SATACRET platform and high value targets program.

And maximize the potential of Danielleza. This April will mark our ten year anniversary [indiscernible] 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 winning some roles from Denmark to The U. S. To more efficiently coordinate the advancement of our print platform [indiscernible] and implementing a small adjustment to Danielle's commercial team to focus the team on potential growth opportunities within the anti GD2 market. [indiscernible] 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 Gentlecore, to provide further color on Daniele's sales for the fourth quarter of twenty twenty four. Thank you, Mike, and good morning, everyone. I joined Y-mAbs in January as the Head of our Daniella business unit. I have twenty one years of experience in biotech focused predominantly on commercial and strategic operations in radiopharmaceuticals and the pediatric rare disease space. Prior to joining Y-mAbs, I served as Chief Commercial Officer and then CEO of ARTEMIS, which was acquired by Telix Pharmaceuticals. Although I've only been at Y-mAbs for two months, I seen a level of passion and commitment across our team that is unmatched. I'm thrilled to be leading the Danielleza business unit.

As the only approved anti GD2 therapy for high risk relapse refractory neuroblastoma in bone and or bone marrow Danielle does 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 Daniella into potential new indications. Let's take a look at some commercial highlights in the fourth quarter of twenty twenty four. We are pleased to have achieved our full year total revenue guidance of $87,700,000 and Daniella net product revenues of $85,200,000 In the fourth quarter of twenty twenty four, total Daniella net product revenues were $24,500,000 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 12/31/2024, total of 69 accounts have ordered Danielleza around The U. S. Since its initial launch in 2021.

With 11 accounts added in 2024. Danielle's estimated total share of The U. S. Anti GD2 market has remained steady at between 1517%. Our dedicated team continues to receive positive healthcare provider feedback on Danielleza 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 Danielleza, which was added to seven hospital formularies in 2024. Bringing the total since initial launch to 48 hospital formularies as of 12/31/2024. The newly realigned business unit structure will allow the Daniella team to focus solely on the upper trajectory of the product. The commercial team will focus on promotion and the rightful positioning of Daniella. 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 Danielleza. At the same time, the medical team will prioritize education, new site start up and produce new and impactful data for Danielleza. 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 twenty twenty four Daniella net product revenues were $7,700,000 an increase of 78% compared to the fourth quarter of twenty twenty three.

The increase in international Danielleza 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. Was partially offset by a decrease in our named patient program in Western Europe. The fourth quarter marked Danielle's highest sales in Western Asia per particularly in Turkey with our partner in Pharmace. And the third consecutive quarter of Daniella's sales in Brazil and Mexico led by our 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 Danielleza 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 Y-mAbs in May of twenty twenty three as Vice President of Business Development and Chief of Staff to the CEO before being appointed to our Head of the Radiopharmaceutical business unit earlier this year. My background includes extensive pharmaceutical strategy and operational execution experience, with specialized experience in radiopharmaceuticals, Previously, I served as Executive Director and Head of Business Plan 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 Theranoptic platform and clinical programs. [indiscernible] Today, I'll provide a recap of our current STATAPRIT 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 status Phase one trial, trial 1,001. A reminder, the primary objective of Trial101 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. [indiscernible] In Part A, we first explored variable protein doses of zero point three, one and three mg per kilogram in a pre targeting interval of two to five days.

As of February 26, we've seen seven sites open and dosed a total of twenty two patients with both Fasata protein and the diagnostic LUTISM payload Of those twenty two patients, nine patients had positive GD2 expression and were eligible for the therapeutic phase of the study to receive up to two hundred millilitaries of luteceum. The initial blood pharmacokinetics profile of these patients dosed 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 toxicity and no instances of any treatment related serious adverse events. Based on the spec CT scans and PK activity we've seen thus far, we believe we've achieved the validity of our data PRIT platform demonstrating the GD2 STATTA 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 the SEDA development program. [indiscernible] As you saw from our update in January, we expect to present a more complete data set from Part A of trial101 in the second quarter of this year including additional scanned images and PK data. [indiscernible] Our second SATAPrint platform CD38 SATA, is in a Phase one trial for the treatment of non Hodgkin 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 a more complete data set from Part A of trial 1,001, we expect to present additional platform optimization that will inform the further advancement [indiscernible] 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 twenty twenty four evaluating the next potential high value targets. We started with a database of over 1,200 targets and narrowed that down to between forty and fifty 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 rank 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 seragnostic pre targeted approach is a potential game changing in the radiopharmaceutical space 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 Danielza net product revenues of $24,500,000 in the fourth quarter of twenty twenty four, representing a 5% increase. Compared to $23,400,000 total Daniels and net product revenues in the fourth quarter of twenty twenty three. This was primarily driven by an increase in international revenues.

That was partially offset by a decrease in U. S. Revenues. U. S. Daniels' net product revenues were $16,800,000 and 19,100,000.0 for the three months ended 12/31/2024, 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 twenty twenty four compared to the fourth quarter twenty twenty three. Ex U. S. Net product revenues were 7,700,000.0 and $4,300,000 for the three months ended 12/31/2024, and 2023, respectively.

Representing a 78% increase The increase in international Daniels and 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 Daniels and net product revenues of $85,200,000 for the year ended 12/31/2024, were relatively flat compared to net product revenues of $84,300,000 dollars for the year ended 12/31/2023. We recorded $2,000,000 of license from Noble Farm. And we reported $2,500,000 of licensing revenue in the year ended 12/31/2024. We did not have licensing revenue for the three months ended 12/31/2023, and we reported $500,000 of licensing revenue for the full year ended December 31. 2023. Research and development expenses were 12,200,000.0 and 13,400,000.0 for the quarter ended 12/31/2024, and 2023, respectively. Our research and development expenses were $49,000,000 dollars for the year ended 12/31/2024, representing a decrease of 5,200,000.0 from $54,200,000 for the year ended December 31, 2023. The decrease in research and development expenses was primarily attributable to the recognition of 4,100,000.0 of milestone and licensing acquisition costs related to our SADA licensing agreement during the year ended 12/31/2023.

Selling and general and administrative expenses increased $1,200,000 and $9,800,000 to 12,400,000.0 and 54,600,000.0 for the quarter and year ended 12/31/2024, respectively. Compared to the same periods in 2023. The increase in SG and A for the three months ended 12/31/2024 was primarily attributable to $500,000 increase in personnel costs inclusive of stock based compensation and a $600,000 restructuring charge related to personnel and stock based compensation costs associated with our business realignment. The increase in SG and A for the year ended 12/31/2024 was primarily attributable to a net impact of $3,800,000 related to the legal settlements in year ended 12/31/2024 The increase also includes a $1,200,000 related to separation and consulting agreements with former executives and $2,200,000 increase in personnel costs associated with stock based compensation. We reported a net loss for the fourth quarter ended 12/31/2024 of $6,800,000 dollars or a negative $0.15 per basic and diluted share as compared to a net loss of $1,000,000 or negative $0.02 per basic and diluted share for the quarter ended 12/31/2023.

In addition, we have reported net loss for the year ended 12/31/2024 of $29,700,000 dollars or negative $0.67 per basic and diluted share as compared to a net loss of $21,400,000 or a negative $0.49 per basic and diluted share for the year ended 12/31/2023. The increase in net loss for the quarter and year ended 12/31/2024 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 twenty twenty four with cash and cash equivalents of 67,200,000.0 as compared to $78,600,000 at the year ended 2023. Representing a decrease of $11,400,000 Importantly, we continue to maintain a strong balance sheet reporting $900,000 cash outflows for the fourth quarter twenty twenty four. Turning now to our full year We are announcing our anticipated full year 2025 total net revenue to be in a range of between $75,000,000 and $90,000,000 As a reminder, historically, Y-mAbs 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 $129,000,000 and $134,000,000 for the full year 2025.

Excluding cost of goods sold, our total net operating expenses is expected to be between 116 and $121,000,000 for the full year 2025. We expect total annual cash investments for full year 2025 be in the range of between $25,000,000 and $30,000,000 In addition, we are also announcing guidance for our first quarter twenty twenty five total net revenue. Which will be between a range of $18,000,000 and $21,000,000 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, a focused business unit strategy, we believe WiMAX 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, Our first question comes from Alex Stranahan with Bank of America. Your line is open.

Hey, guys. Thanks for taking our questions. And appreciate all the updates as we start the year here. Maybe first just on Danielza, given the 1Q and full year 2025 revenue guidance, should we be thinking about a roughly flat trajectory for the most part [indiscernible] maybe be some ups and downs to account for seasonal impacts or or other factors throughout the year? Yes, 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 '25 as we're [indiscernible] supporting some clinical trials. And looking for some additional penetration within the within the high risk relapsedrefractory 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.

Yes, Alex.

Appreciate the question. So first off, just want to remind everybody that we actually for for 2024. We hit those numbers based upon the revised guidance we put out last year. In Q2 of twenty So I think part and parcel to us putting out both full year numbers for this year 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 U. S. 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 the 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 $18,000,000 to $21,000,000 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 will 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.

Yes. 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, Maybe which tissues do you think will be most important outside the tumor from a dose selection perspective? Thank you.

Alex, I think as we look at this, anytime you you look at radiopharmaceuticals, 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 renal elimination of products would be an area that you look at as something that potentially be dose limiting. The second would be hepatic elimination. So what you would have in 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 could 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 salberry and lacromate land 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 has different impacts on the body.

So it's really are you seeing injury from it versus just concentration?

Got it. Thanks for the questions.

Appreciate it, Alex.

Thank you. Our next question comes from Mike Olson 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 $116,000,000 to $121 this year. Just wondering if you can give us the breakdown between R and D and SG and 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 and D evolving there? Thanks.

Yes, Mike, I appreciate it. As we look at this, there will be a couple of things. I'll turn it over to Pete for some of the breakdowns. But as we think about our investment, 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 cost coming out of Danielza on our two zero one study as that's coming to a completion. Which was our post marketing commitment. We also have additional targets coming in to R and D from a SATA perspective. 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 the what our actual spend is and breakdown.

Sure. Thanks, Mike. Mike, good questions. So just to clarify, the $116,000,000 to $121,000,000 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 the today's call, that including cost of goods, that number is more like $129,000,000 to $134,000,000 Coming back to the $116,000,000 to $121,000,000 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 and A kind of cost for 2024 as reported. So that number was about $54,000,000 $55,000,000 But remember in that number, there was about $9,000,000 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 nine that's a base. That base will grow a little bit, but not a lot. Then the rest is kind of R and 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. [indiscernible] 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 and D spend, over time away from Danielle's Can you speak a little bit to how you're thinking about the investigator sponsored studies and investment you are making in Danielleza and how we could look at that impacting revenue looking forward. Say, beyond the 25 guidance?

Yes, Jeff, I appreciate the question. I think one of the things as we look at Danielle's currently our highest cost associated with the R and D with Danielza is on completing our two zero one 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 central registration trial.

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 if that is related to the SADA program or the target something else?

Yes. No, I appreciate that. It's taken a while to get five sites up and running. We had one and running in third quarter and then we brought the rest of them on since It is 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. [indiscernible] So 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 the bridging study. So does the BRIDGE two one thousand and one part B push out a start to advancing a 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 could speak a little bit to 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 1,001 Part B, we anticipate kicking that off in early twenty twenty six. And we think it will be quite quick, especially compared to the Part A of the study. Because we are enrolling fewer number of patients and we're really just testing that in the 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 strategy going forward. But all in all, it will be what we believe a relatively quick bridge to bring us back into the Part D dose escalation phase.

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

Yes.

I mean Part B is 12 and anticipated 12 patients relative to the twenty four, twenty three 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 pets arrested patients So Part B in terms of the timeline will 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, it will be relatively quick.

Okay, great. Thank you so much. Thanks, Nicole.

Thanks, Nicole.

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

Hey, good morning. Thanks for taking the question. I guess for GD2SATA, step for you to select the protein dose from the Part A And then just curious for the nine GD2 positive patients, whether patient received more than one dose of the therapeutic of LUKETIA?

So appreciate it, Lee. 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 we evaluated those, only those patients that showed significant uptake as part of that diagnostic. [indiscernible] 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 approach into advancing the trial.

Okay. And you also mentioned that you'll be looking at, I guess, a number of different sell that target. So just curious what your BD strategy might be I guess, for some of them given it might not be realistic to develop [indiscernible] Yes, 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 radio immune 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. So from an efficiency point of view, they would be more ideal targets to partner with or out license. While the targets that we're looking to bring forward within our franchise is 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 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 Mogen with Clear Street. Your line is open.

Hey, good morning and thanks. So looking at [indiscernible] and the references to an updated and increasingly competitive well, competitive dynamic for Daniel. So can 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 G and A to growth. Thank you. Sure, absolutely. As we look at this, 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 leverage those clinical trials to make sure we're gaining experience out in the market and increasing market share and penetration.

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 Yes. Most of the impact in the near term is 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 we are extremely positive feedback from the lead investigator for the ISS, but also the market as a whole.

And Bill, as we go forward, we look at the opportunity to expand the outpatient option for parents.

And for children that are being treated. And with Danielleza 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.

Coming forward with the CD38, I'll say that 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 antibody to market. For us, there is an unmet need in non Hodgkin's. 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. With an opportunity to get an N of two. So two different targets start comparing some of the data that we're seeing. Time will tell if this develops on how long or how much effort we could give it. But that will be up to Natalie and the team as we look forward to these 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 Eight C. Wainwright. Your line is open.

Hey, guys. Thanks for taking my questions. We're really excited to the update coming in 2Q. Two questions from me, if I may. I guess around the first one, could you provide a little more granular color around the March dynamics in neuroblastoma, especially with the FDA approval of DFMO in late twenty twenty three and how that could potentially be impacting Danielle's sales And then the second question is just around the COGS. Obviously, the COGS were significantly higher this quarter. So just give us some color around that.

Yes.

So I'll start with with the entrain of the FMO. When you look at an inhibitor coming into the market, there's always an opportunity for patients to to try out a new therapy. But we know with inhibitors, it's really limiting to how long they'll be on. And 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 will return to a little bit of an equilibrium.

And but again, there's options for patients, there's options for parents, And as we move forward, you hope that the best options are what's helping the patient maintain and 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 Danielle's 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 in in the ex U. S. Market. You'll see buy ins from us as we're getting in from our higher partners.

Yes, 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 ins 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. So there 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.

Yes, it certainly does. Thank you for that.

Great. Thank you, Robert.

Thank you. Our next question comes from Kim Thalberg with Brookline Capital Markets. Your line is open. Great.

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

Yes, Kevin, I appreciate it. 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 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 who lives mix and as well as WACC. And what that looks like overall. We really don't speak to the competitive products and what they do, but we can really speak to what what we have done and how we see our product.

Yes, Kent. So first off from a WAC perspective, pricing perspective, this is public data, we took 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 payer mix, which I think was your other question. Because obviously there's a component of payer mix that includes Medicaid well as 340B as well as non Medicaid non 340B. And that all folds into those elements. And so 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 give backs on the other side of the equation. I think with regards to the mix, the mix has continued to move more towards Medicaid institutions in terms of sales as we've kind of moved through the last kind of five quarters, year and a half, two years.

As we've kind of migrated in that direction, of course, that is had some impact with regards to overall gross margin to the business. But we see stabilization at this juncture most probably as we move forward. So we did have slight increase in this quarter. Over the last quarter, we had last quarter, we had an increase that, 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, Jeff, on both fronts.

Yes, that's great. Thank you. My second question relates to your efforts to engage with COGS sites and if you could just give a little more detail behind that?

Yes, Kemba, I appreciate it. So when we look at this, 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 Danielle's award We have We have clinical trials, both ongoing as well as [indiscernible] To kick off with some leading COGS 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 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 COGS 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 2024 results. And our continued progress. We believe WiMAX is well positioned to execute and achieve strong strategic priorities across our Daniella and Radiopharmaceutical business unit in 2025 and beyond. We look forward to providing further updates during our radiopharmaceutical pipeline update in GD2 SADA Phase one Part eight data readout planned for second quarter. Thank you all and have a great day. [indiscernible]