Y-mAbs Therapeutics Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
May 13, 2025

There are 14 speakers on the call.

Operator

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

Operator

Please go ahead.

Speaker 1

Thank you, operator, and good morning, everyone. Welcome to the YNAB's first quarter twenty twenty five 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.

Speaker 1

Such statements include, but are not limited to, statements about our business model, commercialization, and product distribution plans, expectations with respect to our business realignment, expectations with respect to clinical trial data, expectations related to current and future clinical and preclinical studies and our research and development programs and regulatory submissions, potential regulatory, marketing, and reimbursement approvals, collaborations or strategic partnerships and the potential benefits thereof, expectations related to our anticipated cash runway and cash investment and the sufficiency of our cash resources and assumptions related thereto, financial guidance and estimates for the first quarter and full year of 2025 and beyond and other statements that are not historical facts. Because forward looking statements involve risks and uncertainties, actual results may differ materially from those expressed or implied by such statements due to a variety of factors, including those risk factors discussed in the company's previously filed annual report on Form 10 ks for the year ended 12/31/2024, as supplemented by the risk factors discussed in the company's quarterly report on Form 10 Q for the quarter ended 03/31/2025, to be filed with the SEC today. In addition, today's discussion will include operating expenses, excluding cost of goods sold, which is a non GAAP financial measure.

Speaker 1

A description of this non GAAP financial measure and a reconciliation of the closest GAAP financial measure is included in today's press release and in the slide presentation available on the IR section of our website at ir. Ymabs dot com. I would now like to turn the call over to our President and CEO, Mike Rossi.

Speaker 2

Thank you, Courtney. Good morning, everyone, and thank you for joining us. Joining me today is Doug Gentlekor, our Daniela business unit head and Pete Frenchu, our chief financial officer. I will begin by reviewing key highlights from our business units from the first quarter and how those accomplishments align to our long term strategy and then discuss our upcoming radiopharmaceutical r and d event on May 28. Next, Doug will provide details on our global Daniela sales performance and commercial strategy.

Speaker 2

Then Pete will provide a detailed account of the first quarter financial results. We made excellent progress in the first quarter of this year following our business realignment announced in January. Just to remind everyone, the company made the decision to establish two distinct internal business units, Danielza and Radiopharmaceuticals. The effort is expected to help maximize the potential of Danielza, while at the same time accelerating the development of our novel SADACrit platform and high value target programs. In the first quarter, we recorded Daniela net product revenues of $20,900,000 coming in at the higher end of our guidance range we provided during our fiscal year end twenty twenty four earnings call in March.

Speaker 2

This represents an 8% increase from the first quarter of last year. Despite a challenging environment with multiple headwinds, I'm very proud of the team's effort and resilience to deliver this caliber of results. We continue to be prudent in our spending, and our financial position remains strong with 60,300,000.0 in cash with an anticipated runway into 2027 based on our current operations. In our radiopharmaceutical business unit, we completed part a of our g d two SADA phase one clinical trial, trial 10 o one in solid tumors. Additionally, we successfully dosed the first patient in our CD38 SADA phase one clinical trial, trial twelve zero one, in patients with relapsed or refractory non Hodgkin's lymphoma, our second clinical program evaluating our novel SodaFit platform, and our first in hematologic malignancies.

Speaker 2

Relapsed or refractory non Hodgkin's lymphoma presents significant challenges for patients facing limited treatment options and a more aggressive disease course. We look forward to advancing our program in the trial, and we'll update you as it progresses. As you may have seen, this morning, we announced we will hold a virtual radiopharmaceutical r and d event on the morning of May 28. At that time, we will provide three key updates. First, the completed data from part a of trial ten zero one, our GD2 SADA trial one clinical trial in solid tumors, and next steps for the program.

Speaker 2

As a reminder, Part A of trial 1,001 is a dose finding study. The data we plan to share will predominantly focus on the safety profile, dosing regimen, and pharmacokinetic and dosimetry details. We anticipate the clinical data will align with our preclinical model to help understand tumor uptake, which will be critical as we move into part two of the study. Second, we will review construct optimization as we move into the next stage of both our current and future programs. Specifically, we will outline changes to be made in the new construct for GD2 SADA and provide data supporting why we believe those changes will improve tumor uptake.

Speaker 2

Third, we will provide pipeline updates, including new plan target programs and anticipated timelines. In the past, we've described our systematic evaluation to identify optimal targets for our platform. We will highlight the compelling commercial opportunities for sending radiation based therapies to those indications and how we plan to do so with a fiscally proven strategy. We look forward to providing you with these exciting updates on our radiopharmaceutical business unit in two weeks. Now let me hand the call over to our Danielza business unit head, Doug Gentlekor, to discuss our commercial progress.

Speaker 3

Thank you, Mike, and good morning, everyone. In January, we executed an internal business unit realignment. For our Danielza business unit, the goal of this realignment was to enhance share of voice and our position within a competitive neuroblastoma U. S. Market, increase penetration and utilization of Danielza in high volume centers, and ultimately maximize the full value of Danielza as an important anti GD2 therapy.

Speaker 3

We believe Danielza has the potential to penetrate The US market even further and increase physician utilization in high risk relapsedrefractory neuroblastoma in bone and or bone marrow. Danielza is the only approved anti GD2 therapy in that specific indication supported by a differentiated mechanism with proven clinical results. We are closely working with investigator sponsors on their trials to advance Danielza into potential new indications to further bolster its commercial potential. Our Danielza team continues to build relationships with new key institutions that have historically not been users of YmAb's differentiated anti GD2 therapy. We see this as a real opportunity to add additional high volume institutions and grow Danielza's market share.

Speaker 3

We are excited to be kicking off a new naxitamab investigator sponsored trial being led by key members of the Children's Oncology Group or COG. We have a lot of interest from additional COG sites to work with us on even more investigator sponsored trials, evaluating a naxitamab and other indication and lines of treatment, and we look forward to working with these sites going forward. We believe this activity, combination with our ongoing work with the BEAT Childhood Cancer Consortium, or BCC, and the new approaches to neuroblastoma treatment consortium, or NAAT, will further grow Daniela's utilization and expand our market reach. We look forward to sharing these updates on these new partnerships as activities progress. Let's now take a look at some commercial highlights in the first quarter of twenty twenty five.

Speaker 3

We are pleased to have achieved the upper end of our first quarter guidance with total net Danielza product revenues of $20,900,000 in the first quarter of twenty twenty five, an 8% increase compared to the prior year period. Ex USADANIELZA net product revenues were $7,500,000 an increase of $6,700,000 compared to the prior year period, driven primarily by our named patient program in Western Asia, which launched in late twenty twenty four as well as product growth in Eastern Asia and Latin America. In The U. S, total net product revenues for the first quarter were $13,400,000 down 28% from the prior year period. The decrease was driven by a number of factors.

Speaker 3

Coming out of the end of twenty twenty four and into the first quarter of twenty twenty five, the company saw new patient enrollment slow largely due to competitive pressure from high enrollment of patients in clinical studies and competitive market dynamics, including continued use of available maintenance therapy. Additionally, some of our largest customers' ordering patterns contribute to the year over year U. S. Revenue decrease. As part of our business unit realignment, we have focused our Danielza commercial operations around accelerating our advocacy development, increasing new patient starts, expansion into new high volume commercial accounts and highlighting financial advantages of Danielza.

Speaker 3

All three of these areas of focus have shown positive returns towards the end of the first quarter and into the second quarter of twenty twenty five. '1 key update since our last call that Danielza in combination with chemotherapy has been added to the NCCN guidelines for the treatment of relapsed or refractory neuroblastoma. With Danielza now included in the NCCN guidelines, we believe this will lead to even more support and interest in our differentiated therapy for relapsedrefractory high risk neuroblastoma. We believe Danielza's addition to the NCCN guidelines coupled with new anticipated investigator sponsored studies at some of the most influential institutions, will position Danielza back on a growth trajectory in The U. S.

Speaker 3

With that, I'll hand the call over to Pete for a broader financial update.

Speaker 4

Thank you, Doug, and good morning, everyone. As you heard earlier, we recorded total Danielza net product revenues of $20,900,000 in the first quarter of twenty twenty five, representing an 8% increase compared to 19,400,000.0 total Daniel's net product revenues in the first quarter of twenty twenty four. The increase was primarily due to an increased ex U. S. Net product revenues of 6,700,000.0 which was partially offset by $5,200,000 decrease in U.

Speaker 4

S. Daniel's net product revenues for the first quarter of twenty twenty five compared to the first quarter of twenty twenty four. Ex U. S. Net product revenues were $7,500,000 and $800,000 for the three months ended 03/31/2025 and 2024, respectively, representing an 816% increase.

Speaker 4

The increase in ex US net product revenues was driven by main patient program in Western Asia, which was launched in late twenty twenty four and an increase in net product sales in Eastern Asia and Latin America. We did not have any licensing revenue for the three months ended 03/31/2025, and we recorded 500,000.0 of licensing revenue in the three months ended 03/31/2024. Research and development expenses were 11,400,000.0 and 13,300,000.0 for the quarters ended 03/31/2025 and 2024 respectively. The 1,900,000.0 decrease in research and development expenses was primarily attributable to a decrease of $700,000 in clinical trials due to the timing of completion in our Phase one GD2 SADA trial 01/2001, investment in our ongoing SADA print programs and a $900,000 decrease in personnel and stock based compensation costs, partially offset by $600,000 increase in outsourced manufacturing and investment in our naxitamab program. Billing and general administrative expenses increased 1,700,000.0 to 13,100,000.0 for the quarter ended 03/31/2025 compared to 11,400,000.0 in the same period of 2024.

Speaker 4

The 1,700,000.0 increase in selling, general, and administrative expenses was primarily attributable to a 800,000.0 increase in personal and stock based compensation costs, a 500,000.0 charge related to our business realignment, and a 400,000.0 increase in legal expenses recorded in the three months ended 03/31/2025. We have recorded a net loss for the quarter ended 03/31/2025 of 5,200,000.0 or a negative 12¢ per basic and diluted share as compared to a net loss of 6,600,000.0 or a negative 15¢ per basic and diluted share for the quarter ended 03/31/2024. The decrease in net loss for the quarter ended 03/31/2025 was primarily driven by an increase in net product revenues and a favorable impact from foreign currency transactions. With our business unit realignment strategy announced in January of this year, we have now organized into two internal business units, Danielza and Radiopharmaceuticals. Our business units are focused on different products and platforms.

Speaker 4

They're managed separately as business units require and also require different research, development, marketing, and operational investments. Their segment profit and losses from operations also include certain noncash costs. Our Daniela business unit reflects a segment profit from operations of $8,800,000 which was a 42% segment profit margin based on total revenues of $20,900,000 for the first quarter of twenty twenty five. Segment profit from operations during the first quarter of twenty twenty four was $8,700,000 or 44% segment profit margin based on total revenues of 19,900,000.0 Our radiopharmaceuticals business unit reflects a segment loss or investment from operations of 6,100,000.0 and 6,000,000 for the first quarters of twenty twenty five and 2024 respectively. As mentioned earlier, we ended the first quarter of twenty twenty five with cash and cash equivalents of 60,300,000.0 as compared to $67,200,000 at year ended 2024, representing an investment of $6,900,000 for the first quarter of twenty twenty five.

Speaker 4

The company continues to be capital efficient, and we are currently operating below our anticipated cash investment guidance for the full year of 2025. Turning now to our full year 2025 guidance, we reiterate our anticipated full year 2025 total revenue, operating expenses and cash investment as well as our ability to fund operations as currently planned into 2027. In addition, we are also announcing guidance for our second quarter of twenty twenty five total revenue, which is expected to be between the range of $17,000,000 and 19,000,000 This guidance range aligns with our second quarter trends in prior years, excluding stocking orders. The company is committed to providing guidance numbers that are realistic. Finally, I want to provide some color around potential tariffs that may impact our organization.

Speaker 4

Danielza is manufactured both in The US and outside The US today. We conducted an analysis of our supply chain to understand the potential exposure to tariffs. At this moment, we anticipate that potential tariff increases would have a minimal impact on Y Maps. We're continuing to monitor geopolitical developments as they evolve. With a strong balance sheet and a focused business unit strategy, we believe YMAPS is well positioned to execute our strategic mission and priorities and to support the delivery of multiple anticipated milestones in the year ahead.

Speaker 4

This concludes the financial update. And now I will turn the call back over to Mike.

Speaker 2

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

Operator

Thank you. To ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. We ask that you please limit to one question and one follow-up. And the first question comes from Nicole Germino with Truist.

Operator

Your line is now open.

Speaker 5

Good morning, and thanks for taking my question. So for Danielza, can you just help us better understand how to think about The US and ex US revenue dynamics? And what are the push and pull that get us to the higher end of the range? Thanks.

Speaker 2

Nicole, thank you very much. The I'll turn that over to Doug, and Doug can address the big one. Okay?

Speaker 3

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

Speaker 3

Aside from that, yeah, we're we're seeing what we're essentially expecting both in and outside The US.

Speaker 2

And, Nicole, we continue to see the eighty, twenty, 70, 30 rule with, US, ex US, and that continues to, continues to hold true for us.

Speaker 5

Okay. Great. And then just one quick follow-up. On, your competitor in The US, do you do you see, any more switching dynamics there, or can you help us, understand those switching dynamics and how that's gonna evolve for the rest of the year and longer term?

Speaker 2

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

Speaker 5

Great. Thank you so much.

Operator

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

Speaker 6

Good morning. Thanks for taking the question. Maybe just another one on Danielza. Looks like your 2Q revenue guidance does imply a little bit of a downtrend in 2Q over 1Q. You mentioned some sort of historical trends there.

Speaker 6

Maybe just talk a little bit more about that and how to think about progress in February. Thanks.

Speaker 2

Yeah, Mike. You know, as we look at this, there is seasonality within the product, and we're forecasting for that. Also, as you look at US versus international, very strong start on on the ex US side, in the first quarter. So, you know, as the guidance goes out, I think it's it's realistic for us to look at this and factor in both the seasonality as well as the international prevalence pool of patients, where we have treated multiple patients in in q one that won't be available in q two.

Speaker 4

Yeah. Mike, I'll add a little bit more texture to your question as well on top of what Mike said. So if you look at our U. S. Sales for last year in the second quarter, we did $15,200,000 What we're kind of projecting is kind of U.

Speaker 4

S. To be slightly up quarter on quarter year over year. Ex U. S, Second Quarter Twenty Twenty Four, we had a lot of stock ins. I think that alludes to an earlier comment that was made.

Speaker 4

If you look at second quarter twenty twenty four, we had about almost $5,000,000 of stock ins in Western Europe, Latin America and Eastern Asia. We don't anticipate those stock ins in the second quarter of this year. So when you kind of do the math on that, that really comes back to a guidance range of 17,000,000 to $19,000,000 I would stress, Mike, as you can kind of see with first quarter guidance, we're trying to provide you guys with the next quarter's guidance every quarter to give you guys a really good understanding and view as to some of the effects of stock and seasonality, various other things so that we actually can kind of land in the range that we're projecting. We feel very comfortable. And again, I think as we alluded to in the script, we're just trying to be realistic about guidance.

Speaker 4

Coming back to an earlier question, full year, we still are very convinced with regards to the 75,000,000 to $90,000,000 overall guidance range. We still believe we're going to land in that zone. Things are looking good for the full year. I think as we view that The US will start to rebound a bit for us based upon a lot of great work that's going on in the company around the business unit realignment and specifically Danielza. So as you guys think about your models, just adjust them accordingly, as you think about kind of the the second half of the year.

Speaker 4

Hopefully, that helps, Mike.

Speaker 6

No. Very helpful. Thanks for the additional color.

Speaker 2

Yep.

Operator

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

Speaker 7

Hi. Thanks for taking the question. I'm wondering if you

Speaker 8

can comment on any current plans for naxitamab in osteosarcoma.

Speaker 2

Yeah. We we continue to, support ISS in osteosarcoma. Also, looking at the, the potential of developing, a better diagnostic to determine g two expression. G d two is very difficult as you look at, the challenges around having an IHC for that. So, you know, we've learned a lot in our our ten o one trial on the, on the SATA g d two.

Speaker 2

So with that, I think, we'll be able to accelerate development, with better patient selection in osteosarcoma. Great. Thanks for taking the question.

Speaker 3

Thanks, Justin.

Operator

The next question comes from Lee Wotzik with Cantor. Your line is open.

Speaker 9

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

Speaker 9

Thanks.

Speaker 2

Yeah, Lee. Thank you very much for that. We're going to have a much deeper dive on our radiopharmaceutical platform on the twenty eighth. But just to give you a little bit of color, we dosed the first patient. It is a smaller, overall subset of patients than we were looking at for our g d two, but it is a very challenging indication in the relapsed refractory non Hodgkin's, to recruit patients.

Speaker 2

That's why it was a bit challenging in in finding the right patients to dose. But for us, it's this is, it's a platform safety study. So with that, we're looking at ways to accelerate it. But right now, the plan isn't around 12 to 15 patients. So it is less patients than we saw in the, in the 10 o one trial.

Speaker 4

Thank you. Thank you, Lee.

Operator

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

Speaker 10

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

Speaker 10

Thanks.

Speaker 2

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

Speaker 4

Yes, John. Great question. As you know, from some prior quarters, we've had some adjustments as we've gone quarter on quarter, especially through the course of 2024. I think what I would say to you is that we're now starting to see some stabilization in that Medicaid three forty b gross to net elements. So, you know, we don't anticipate major changes as we go forward kind of in 2025.

Speaker 4

I know we had some more significant adjustments in 2024 in various quarters. But, again, we're starting to see some stabilization. I think some of that, especially the three forty b, is associated with a bit more of the revenue shift to outside certain institutions where they actually have patients in three forty b. So and then on the Medicaid side, again, stabilization. So it's overall, I think the answer is, you know, 2025, we don't anticipate any major kind of adjustments at this time.

Speaker 4

So okay. Hopefully, that

Speaker 2

helps Yes.

Speaker 10

Thank you. And

Operator

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

Speaker 3

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

Speaker 2

Hey, Jeff. I appreciate it. Good question. Again, just from a a top line perspective, what we're looking to do is increase the affinity, to the the receptor as well as, the duration that it sits on the tumor, which will improve the overall uptake. There'll be a bridging study that goes on between where we are today and the part b, just to show, the safety and efficacy of the the new linker.

Speaker 2

And, again, it's a proprietary link across. So we'll go into this much deeper, on the twenty eighth. But what we plan to do is is have that out for, in the second half of this year with, essentially being completed, probably next year.

Speaker 4

Great. Thank you.

Speaker 2

Thank you.

Operator

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

Speaker 11

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

Speaker 2

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

Speaker 3

Yeah. So thank you. The first thing that we have been focused on, and quite frankly, this business as a whole has been focused on for the last year to eighteen months is developing advocates and further developing that advocacy to be more vocal in the market. We're starting to see that reflected with the change in the NCCN guidelines that were recently announced as well as some of our, KOL development. It starts to really move us back into a position where we are in the clinical discussion when it comes to treating these very sick patients.

Speaker 3

So the first thing starts with advocacy. The second piece is developing stronger financial messaging around Danielle's and specifically around outpatient and the benefits of outpatient treatment in this disease state. And then finally, it's around global expansion, which we referred to earlier, a few different times, but finding the markets where, it is preferable and viable for, Danielza through our partners and where there are growth opportunities. So we continue to, follow that playbook. And, again, as I said earlier, we're starting to see those results.

Speaker 3

But, you know, it really starts and ends with advocacy. And, again, we see that change in the NCCN guidelines as a direct reflection of how we have, moved the advocacy needle in our favor.

Speaker 11

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

Speaker 11

Thank you.

Speaker 4

Yeah.

Speaker 2

That's that's another good question, Bill, and and we'll definitely get into that in a much deeper way. But what the changes we're making and the advances we're making are platform related. So as we learn from the g d two and c d 38, you know, you go from an n of one to an n of two and and as we add additional products and and looking at our preclinical versus our clinical data, the changes we make will be platform wide. So as we move to, proprietary link or chelator that has a higher affinity and and duration on the tumor, that'll be the new platform moving forward. We started with, the Naked DOTA as a way to get into patients quickly in a very safe way, without having two different variables.

Speaker 2

So we've, isolated the the safety on the g d two SADA, and we're in the process of the c d thirty eight. Now moving into the proprietary linker and chelator, it will be the same, linker chelator combinations by isotope for all of the SADA drugs moving forward. So we have that opportunity as we learn to, apply it back to all of the future constructs.

Speaker 11

Great. Thanks.

Speaker 2

Thanks, Paul.

Operator

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

Speaker 2

Hey. Thanks. Most of my questions actually were the

Speaker 10

previous questions,

Speaker 12

but I have one more with relating to the platform. I know you'll go into it more, but the if you're swapping out the linker to increase, you know, affinity and residence time, I have to ask you, like, basically, why did you open up the CD 38, the NHL study? Are you gonna swap that out too, or or, you know, kind of, like, you know, walk me through the the reasoning there if if you're on track to, you know, change out the linker and and, you know, improve the, SADA, you know, targeting the residence time. Thanks.

Speaker 2

Now, David, good question. As we looked at this, it was important to to get in and establish the safety of the protein. So that doesn't change. So the c d 38 SADATA construct is the same regardless of what link or chelator combination we're using. So the the entire purpose of both the 10 o one and the 12 o one is looking at the overall safety of the the SADA platform.

Speaker 2

And similar to the 10 o one with g d two, you wanna have as few variables possible. So maintaining the the naked DOTA, on the lutetium gives you that that safety information you need from the c d 38 so that when the safety is established as part of the bridging study, for the new chelator linker, that can then be translated back in as an amendment to start looking at that as you advance the product forward for treatment. So, again, it's it's about establishing the safety of the protein, about the speed of of getting that information, and then making the change once you have, that variable down that, you know, you're confident that there's no safety signals from the the protein itself.

Speaker 4

Okay.

Speaker 2

Thanks, David.

Operator

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

Speaker 4

Great, thank you. Are you seeing stabilization in the number of cycles per patient for Danielza now?

Speaker 2

Kim, that's a good question. Doug?

Speaker 4

Yeah.

Speaker 3

Stabilization is is relevant, but I think, overall, we see the volumes be remain consistent at each each individual facility. There are small changes in protocols, but in general, we've seen year over year growth in number of vials per patient in The US. We see similar trends abroad. I think the biggest area of focus for us is less around number of vials per patient. It's more around, penetrating large accounts that are utilizing a number of anti GD two drugs and, making sure that Daniela has its rightful place in that treatment paradigm.

Speaker 3

So while we will continue to support and educate on number and how each individual patient is treated from a number of vials standpoint, our real focus is making sure that the clinically relevant information is in the hands of the decision makers, specifically the clinicians that are treating these patients.

Speaker 4

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

Speaker 3

So the the protocols and the setup of the study is in the hands of the investigator. We're just supporting them. But this particular this next study will have, multiple cog facilities involved, and they are key and, obviously, luminary facilities amongst that group. So we're quite excited about how this, study has evolved and developed. We do anticipate a a very near term start.

Speaker 3

So, hopefully, there will be market information available to the market in the very near future about the sites and and what level of involvement.

Speaker 4

Great. Thank you so much.

Speaker 2

Thank you, Tim.

Operator

And our next question will come from Chiara Montorani with Van La Chat Kempen. Your line is open.

Speaker 13

Hello, team. Thanks for taking my question. Congratulation with the progress as well. So, one question for me about, Danielza and the inclusion in the, NCC, and guidelines, but also regarding indeed the new investigator led, trial in collaboration with the Cox advocacy groups. I was wondering if you could talk a little bit more, how do you see this impacting Danielza growth?

Speaker 13

Do you think that the guidelines, will have an impact on shifting the, clinician choice versus competitor? And, also, if you could repeat again, when do you anticipate to, that the investigator will initiate this trial, please? Thank you.

Speaker 2

Thank you, Kara. I'll turn it over to Doug. He can he can address the NCCN guidelines as well as the the timing on the ISS.

Speaker 3

As far as the NCCN guidelines are concerned, we see this as putting us on similar footing with our competition from a recommendation standpoint. Now the decision making process still exists at the clinician level. Again, back to reiterating where our focus is is around educating and, you know, providing information to clinicians making decisions on a day in, day out basis, but it really, removes what was a headwind for some, in certain accounts not being included in the guidelines and does provide a potential tailwind for the team and and the market as a whole to reevaluate the placement of Daniela in the treatment paradigm. So while and Peter referenced earlier, we're not moving any guidance. We do anticipate, some more open doors for the team, to have discussions clinically.

Speaker 3

And, again, kinda rounding it to both the clinical and the financial message not related to the guidelines, but just general around treatment with Danielza. So, in summary, it most likely removes a headwind and provides some, potential for some tailwinds now that we are referencing the guidelines. From a timing on the call trial, we've been consistent with q two. We're not changing that timeline. We think we're a matter more like days than weeks from the start of this, so we're quite excited about the start of that, and so are the investigators, quite frankly.

Speaker 3

So a lot of positive momentum for Daniel's in the market with some accounts that really don't have or at least previously hadn't had significant experience with the product.

Speaker 2

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

Speaker 13

Thank you very much.

Speaker 3

Thanks, Kiera.

Operator

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

Speaker 10

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

Speaker 2

Yeah. Alex, it's a great question. As we look at this, the two way designation for us, I mean, that is expected. And it it when you look at it, the the it is the level of information. So these are rare diseases or ultra rare diseases with, small patient populations and not the widespread data you see with, drugs that are in in a much larger patient population.

Speaker 2

So the two a is is expected and and the same as as the competitor. So with that, it gives us, reassurance that we're on the the same playing field. And, also, it was it's a high level of confidence from the NCCN panel as well. So it's, it puts us in a very good position and and on a level playing field with competition.

Speaker 10

Okay. Great. That makes sense. And maybe just one one more sort of higher level. Any comments on the new appointments at FDA or or CBER?

Speaker 10

Any changes in your regulatory interactions or development approach for for any of your assets? Thanks.

Speaker 2

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

Speaker 2

So we feel very good about where we are today, and and hopefully, that that continues in the future.

Speaker 10

Appreciate the color, and thanks for the questions.

Operator

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

Speaker 2

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

Operator

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

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Key Takeaways

  • Weimab organized into two internal business units—Danielza and Radiopharmaceuticals—to maximize commercial potential of Danielza and accelerate development of its novel SADA platform.
  • In Q1, Danielza net product revenues reached $20.9 M (up 8% year-over-year), with ex-US sales growing 816% and US revenues down 28%, leading to Q2 guidance of $17 M–$19 M.
  • Radiopharma BU completed Part A of the GD2 SADA Phase I trial and dosed the first patient in the CD38 SADA trial for relapsed/refractory non-Hodgkin’s lymphoma, with a virtual R&D event on May 28 to present safety/dosing data, construct optimizations, and pipeline updates.
  • Danielza was added to the NCCN guidelines for relapsed/refractory neuroblastoma, and multiple investigator-sponsored trials with COG, BCC, and NAAT are underway to drive new patient starts and further market penetration.
  • Weimab ended Q1 with $60.3 M in cash, maintaining a runway into 2027, reported a net loss of $5.2 M (vs. $6.6 M prior year), decreased R&D spend, and reaffirmed full-year 2025 financial guidance.
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Earnings Conference Call
Y-mAbs Therapeutics Q1 2025
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