Q1 2025 Y-mAbs Therapeutics Inc Earnings Call

May 13, 2025

Smoke instructions for the question and answer session will follow their prepared remarks.

As a reminder, today's conference will be recorded.

Courtney Dougan: I would now like to hand, the call over to why maps head of IR Courtney Dougan. Please go ahead.

Courtney Dougan: Thank you operator, and good morning, everyone welcome to the wine out first quarter 2025 financial results Conference call.

Courtney Dougan: 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.

Courtney Dougan: 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.

Courtney Dougan: 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.

Courtney Dougan: Expectations with respect to clinical trial data.

Courtney Dougan: Expectations related to current and future clinical and preclinical studies, and our research and development programs and regulatory submissions potential.

Courtney Dougan: Potential regulatory marketing and reimbursement approvals collaborations.

Courtney Dougan: Collaborations or strategic partnerships and the potential benefits thereof.

Courtney Dougan: Expectations related to our anticipated cash runway and cash investment and the sufficiency of our cash resources and assumptions related thereto.

Courtney Dougan: <unk> financial guidance and estimates for the first quarter and full year of 2025 and beyond and other statements that are not historical facts.

Courtney Dougan: Because forward looking statements involve risks and uncertainties actual results may differ materially from those expressed or implied by such statements due to a variety of factors, including those risk factors discussed in the company's previously filed annual report on Form 10-K for the year ended December 31 2024.

Courtney Dougan: Supplemented by the risk factors discussed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2025 to be filed with the SEC today.

Courtney Dougan: In addition, today's discussion will include operating expenses, excluding cost of goods sold which is a non-GAAP financial measure.

Courtney Dougan: A description of this non-GAAP financial measure.

Courtney Dougan: 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 Dot one dot com on that.

Courtney Dougan: I would now like to turn the call over to our President and CEO, Mike Rossi.

Speaker Change: Thank you Courtney.

Mike Rossi: Morning, everyone and thank you for joining us.

Speaker Change: Joining me today.

Speaker Change: Are there any other business units.

Speaker Change: <unk>, our chief Financial Officer.

Speaker Change: I will begin by reviewing key highlights from our business units from the first quarter and how those accomplishments aligned to our long term strategy.

Speaker Change: And then discuss our upcoming radiopharmaceutical R&D event on May 28.

Doug: Next Doug will provide details on our global Daniels with sales performance and commercial strategy.

Pete: Then Pete will provide a detailed itself of the first quarter financial results.

Pete: We made excellent progress in the first quarter of this year following our business realignment announced in January.

Pete: Just to remind everyone. The company made the decision to establish two distinct internal business units Daniels up in Radiopharmaceuticals.

Pete: The effort is expected to help maximize the potential of Danielle so while at the same time accelerating the development of our novel Sard, a great platform and high value target programs.

Pete: In the first quarter, we recorded Danielle the net product revenues of $29 million coming in at the higher end of our guidance range. We provided during the fiscal year end 2024 earnings call in March.

Pete: This represents an 8% increase from the first quarter of last year.

Pete: Despite a challenging environment with multiple headwinds I'm very proud of the team's effort.

Pete: And resilience to deliver this caliber of results.

Operator: 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.

Pete: We continue to be prudent in our spending and our financial position remains strong with $63 million in cash with an anticipated runway into 2027 based on our current operations.

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 Companys previously filed annual report on Form 10-K for the year ended December 31 2024.

Courtney Dugan: I would now like to hand the call over to Y-mAbs Head of IR, Courtney Dugan. Please go ahead. Thank you, Operator, and good morning, everyone.

Pete: And our radiopharmaceutical business unit, we completed part a of our Jimmy Choo sort of phase one clinical trial trial <unk> hundred one in solid tumors.

Courtney Dugan: Welcome to the YNAB First Quarter 2025 Financial Results Conference. 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.

Pete: Additionally, we successfully dosed the first patient in our CD 38 sort of phase one clinical trial trial <unk> in patients with relapsed or refractory non Hodgkin's lymphoma, our second clinical program evaluating our novel <unk> platform and our first in hematologic malignancies.

Supplemented by the risk factors discussed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2025 to be filed with the SEC today.

In addition, today's discussion will include operating expenses, excluding cost of goods sold which is a non-GAAP financial measures.

Courtney Dugan: Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our business model, commercialization, and product distribution plans, expectations with respect to our business realignment, expectations with respect to clinical trial data, expectations related to current and future clinical and preclinical studies and our research and development programs, and regulatory submissions. Potential regulatory, marketing, and reimbursement approval. 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.

Pete: Relapsed or refractory non Hodgkin's lymphoma presents significant challenges for patients facing limited treatment options and a more aggressive disease course.

A description of the non-GAAP financial measure.

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 Dot one dot com.

Pete: We look forward to advancing our program in the trial and we'll update you as it progresses.

I would now like to turn the call over to our President and CEO, Mike Rossi.

Pete: As you May have seen this morning, we announced we will hold a virtual radiopharmaceutical R&D event on the morning of May 28.

Speaker Change: Thank you Courtney.

Speaker Change: Good morning, everyone and thank you for joining us.

Speaker Change: Joining me today is Doug Journal Corr, our Daniels a business unit.

Pete: At that time, we will provide three key updates.

Pete: And Pete <unk>, our Chief Financial Officer.

Pete: First the completed data from part a of trial <unk> hundred one our JV to solid trial, one clinical trial in solid tumors and next steps for the program.

Pete: I will begin by reviewing key highlights from our business units.

Pete: In the first quarter and how those accomplishments aligned to our long term strategy.

Pete: As a reminder, part a of trials that are one is a dose finding study.

Pete: And then discuss our upcoming radiopharmaceutical R&D event on May 28.

Courtney Dugan: Financial guidance and estimates for the first quarter and full year of 2025 and beyond, and other statements that are non-historical facts.

Pete: The data we plan to share will predominantly focus on the safety profile dosing regimen, and pharmacokinetic and dosimetry details.

Doug: Next Doug will provide details on our global Daniels with sales performance and commercial strategy.

Courtney Dugan: Because forward-looking statements involve risks and uncertainties, actual results may differ materially from those expressed or implied by such statements due to a variety of factors, including those risk factors discussed in the company's previously filed annual report on Form 10-K for the year ended December 31, 2024, as supplemented by the risk factors discussed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2025, to be filed with the SEC today.

Doug: Then Pete will provide a detailed account of the first quarter financial results.

Pete: 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.

Speaker Change: We made excellent progress in the first quarter of this year following our business realignment announced in January.

Pete: Second we will review construct optimization as we move into the next stage of both our current and future programs.

Doug: Just to remind everyone. The company made the decision to establish two distinct internal business units Daniels us in Radiopharmaceuticals.

Pete: Specifically, we will outline changes to be made in the new contract for Gd to setup and provide data supporting why we believe those changes will improve tumor uptake.

Doug: The effort is expected to help maximize the potential of Danielle so while at the same time accelerating the development of our novel <unk> platform and high value target programs.

Courtney Dugan: In addition, today's discussion will include operating expenses, excluding cost of goods sold, which is a non-GAAP financial measure. A description of this non-GAAP financial measure and a reconciliation of the closest GAAP financial measure is included in today's press release and in the slide presentation available on the IR section of our website at ir.ymabs.com.

Pete: Third we will provide pipeline updates, including new planned target programs and anticipated timelines.

Doug: In the first quarter, we recorded Danielle the net product revenues of $29 million coming in at the higher end of our guidance range. We provided during our fiscal year end 2024 earnings call in March.

Pete: In the past we've described our systematic evaluation to identify optimal targets for platform.

Pete: We will highlight the compelling commercial opportunities for extending radiation based therapies to those indications and how we plan to do so with a fiscally prudent strategy.

Doug: This represents an 8% increase from the first quarter of last year.

Mike Rossi: I would now like to turn the call over to our President and CEO, Mike Rossi. Thank you, Courtney. Good morning, everyone, and thank you for joining.

Doug: Despite a challenging environment with multiple headwinds I'm very proud of the team's effort.

Pete: We look forward to providing you with these exciting updates on our Radiopharmaceuticals business unit in two weeks.

Doug: And resilience to deliver this caliber of results.

Mike Rossi: Joining me today is Doug Gentilcore, our Daniela Business Unit Head, and Peter Pfreundschuh, our Chief Financial Officer. I will begin by reviewing key highlights from our business units from the first quarter and how those accomplishments align to our long-term strategy.

Doug: We continue to be prudent in our spending and our financial position remains strong with $63 million in cash with an anticipated runway into 2027 based on our current operations.

Doug: Now, let me hand, the call over towards Daniels, a business unit head, Doug general floor to discuss our commercial progress.

Speaker Change: Thank you Mike and good morning, everyone. In January we executed an internal business unit realignment for our Daniels's business unit. The goal of this realignment was to enhance share of voice and our position within a competitive neuroblastoma U S market.

Doug: And our radiopharmaceutical business unit, we completed part a of our GBP two sought a phase one clinical trial trial <unk> hundred one in solid tumors.

Mike Rossi: And then discuss our upcoming radiopharmaceutical R&D event on May 28.

Doug Gentilcore: Next, Doug will provide details on our Global Danielle with Sales Performance and Commercial Strategy.

Speaker Change: Increased penetration and utilization of Daniela and high volume centers and ultimately maximize the full value of Daniela as an important anti <unk> therapy. We believe Daniela has the potential to penetrate the U S market, even further and increase physician utilization high risk relapsed refractory neuroblastoma and bone and <unk>.

Doug: Additionally, we successfully dosed the first patient in our CD 38 sort of phase one clinical trial trial <unk> hundred one.

Mike Rossi: Then people 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.

Doug: Patients with relapsed or refractory non Hodgkin's lymphoma, our second clinical program evaluating our novel Sada platform.

Mike Rossi: Just to remind everyone, the company made the decision to establish two distinct internal visits. Danielza and Radio Pharmaceuticals. The effort is expected to help maximize the potential of Danyalpha, while at the same time accelerating the development of our novel SADA CRIT platform and high-value target program. In the first quarter, we recorded, Danielle, the net product revenues of $20.9 million, coming in at the higher end of our guidance range we provided during the fiscal year-end 2024 earnings policy. This represents an 8% increase from the first quarter of last year.

Doug: And our first in hematologic malignancies.

Speaker Change: Daryl Daniels is the only approved anti <unk> therapy in that specific indication supported by a differentiated mechanism with proven clinical results. We are closely working with investigators sponsors on their trials to advance daniels's into potential new indications to further bolster its commercial potential.

Doug: Relapsed or refractory non Hodgkin's lymphoma presents significant challenges for patients facing limited treatment options and a more aggressive disease course.

Doug: We look forward to advancing our program in the trial and we'll update you as it progresses.

Speaker Change: Our Daniels the team continues to build relationships with new key institutions to have historically not been users of <unk> differentiated anti <unk> therapy.

Doug: As you May have seen this morning, we announced we will hold a virtual radiopharmaceutical R&D event on the morning of May 28.

Doug: At that time, we will provide three key updates.

Speaker Change: We see this as a real opportunity to add additional high volume institutions and grew daniels's market share.

Doug: First the completed data from part a of trial <unk>, one or <unk> two solid trial, one clinical trial in solid tumors and next steps for the program.

Speaker Change: We are excited to be kicking off a new next at a mab investigator sponsored trial being led by key members of the children's oncology group or cog.

Mike Rossi: Despite a challenging environment with multiple headwinds, I'm very proud of the team's effort and resilience to deliver this caliber of results. We continue to be prudent in our spending, and our financial position remains strong, with $60.3 million in cash, with an anticipated runway into 2027, based on our current operations.

Speaker Change: We have a lot of interest from additional Cogs sites to work with us on even more investigator sponsored trials evaluating <unk> in other indications and lines of treatment.

Doug: As a reminder, part a of trials that are one is a dose finding study.

Doug: The data we plan to share will predominantly focus on the safety profile dosing regimen, and pharmacokinetic and dosimetry details.

Speaker Change: And we look forward to working with these sites going forward.

Speaker Change: We believe this activity in combination with our ongoing work with the beat childhood cancer consortium or BCC and the new approaches to neuroblastoma treatment consortium Burnett will further grow daniels's utilization and expand our market reach we look forward to sharing these updates on these new partnerships as activities progress.

Doug: 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.

Mike Rossi: In our radiopharmaceutical business unit, we completed Part A of our GD2-SADA Phase 1 clinical trial, Trial Panel 1, and followed to Additionally, we successfully dosed the first patient in our CD38 SADA phase 1 clinical trial, trial 1201, in patients with relapsed or refractory non-Hodgkin's lymphoma, our second clinical program evaluating our novel SADA platform, and our first in hematologic malignancy. Relaxed 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.

Doug: Second we will review construct optimization as we move into the next stage of both our current and future programs.

Speaker Change: Let's now take a look at some commercial highlights in the first quarter of 2025.

Doug: Specifically, we will outline changes to be made in the new contract for Gd to Sada and provide data supporting why we believe those changes will improve tumor uptake.

Speaker Change: We're pleased to have achieved the upper end of our first quarter guidance with total net daniels's product revenues of $29 million in the first quarter of 2025, and 8% increase compared to the prior year period.

Doug: Third we will provide pipeline updates, including new planned target programs and anticipated timelines.

Doug: In the past we've described our systematic evaluation to identify optimal target for platform.

Speaker Change: USA Daniels's net product revenues were $7 5 million, an increase of $6 7 million compared to the prior year period, driven primarily by our named patient program in Western Asia, which launched in late 2024, as well as product growth in Eastern Asia and Latin America.

Doug: We will highlight the compelling commercial opportunities for extending radiation based therapies to those indications and how we plan to do so with a fiscally prudent strategy.

Mike Rossi: As you may have seen, this morning we announced we will hold a virtual radiopharmaceutical R&D event on the morning of May 28th. At that time, we will provide three key updates. First, the completed data from Part A of Trial 10-01 are GD2, SADA Trial 1 clinical trial, and solid tumor. and next steps for the program. As a reminder, Part A of Trial 101 is a dose-finding study. The data we plan to share will predominantly focus on the safety profile, dosing regimen, and pharmacokinetic endosymmetry detail. We anticipate the clinical data will align with our preclinical model to help understand tumor uptake, which will be critical as we move into Part 2 of the study.

Doug: We look forward to providing you with these exciting updates on our Radiopharmaceuticals business unit in two weeks.

Speaker Change: In the U S. Total net product revenues for the first quarter were $13 $4 million down 28% from the prior year period. The decrease was driven by a number of factors.

Doug: Now, let me hand, the call over towards Daniels, a business unit head Dove channel quarter to discuss our commercial progress.

Speaker Change: Coming out of the end of 2024 and into the first quarter of 2025. The company saw new patient enrollments slow largely due to competitive pressure from high enrollment of patients in clinical studies and competitive market dynamics, including the continued use of available maintenance therapy. Additionally, some of our largest customers ordering patterns and contribute to the year over year.

Speaker Change: Increased penetration and utilization of Daniela and high volume centers and ultimately maximize the full value of Daniela as an important anti <unk> therapy. We believe Danielle that has the potential to penetrate the U S market, even further and increase physician utilization high risk relapsed refractory neuroblastoma and bone <unk> bone.

Speaker Change: U S revenue decrease.

Speaker Change: As part of our business unit realignment, we have focused our daniels of commercial operations around accelerating our advocacy development, increasing new patient starts expansion into new high volume commercial accounts and highlighting financial advantages of Daniels.

Mike Rossi: 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-SATA and provide data supporting why we believe those changes will improve tumor uptake. Third, we will provide pipeline updates, including new planned target programs and anticipated timelines. In the past, we've described our systematic evaluation to identify optimal targets for a class. We will highlight the compelling commercial opportunities for extending radiation-based therapy to those indications.

Speaker Change: Narrow.

Speaker Change: Danielle <unk> is the only approved anti <unk> therapy in that specific indication supported by a differentiated mechanism with proven clinical results. We are closely working with investigators sponsors on their trials to advanced daniels's into potential new indications to further bolster its commercial potential.

All three of these areas of focus have shown positive returns towards the end of the first quarter and into the second quarter of 2025.

Speaker Change: One key updates since our last call that Daniels in combination with chemotherapy has been added to the NCC guidelines for the treatment of relapsed or refractory neuroblastoma with Daniels are now included in the <unk> guidelines. We believe this will lead to even more support and interest in our differentiated therapy for relapsed refractory high risk <unk>.

Speaker Change: Our Daniels a team continues to build relationships with new key institutions to have historically not been users of <unk> differentiated anti <unk> therapy.

Speaker Change: We see this as a real opportunity to add additional high volume institutions and grew daniels's market share.

Speaker Change: Aero Blastoma, we believe daniels's edition to the NCC guidelines, coupled with new anticipated investigator sponsored studies at some of the most influential institutions will position Daniels up back on a growth trajectory in the U S.

Speaker Change: We're excited to be kicking off a new next at a mab investigator sponsored trial being led by key members of the children's oncology group or Cogs, we have a lot of interest from additional Cogs sites to work with us on even more investigator sponsored trials evaluating <unk> in other indications and lines of treatment.

Mike Rossi: and how we plan to do so with a fiscally prudent strategy.

Mike Rossi: We look forward to providing you with these exciting updates on our radio pharmaceutical business unit in two weeks.

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

Pete: Thank you, Doug and good morning, everyone.

Doug Gentilcore: Now, let me hand the call over to our Danielle's a business unit head, Doug Gentilcore, to discuss our commercial progress. Thank you, Mike, and good morning, everyone. In January, we executed an internal business unit realignment for our Danielza business unit. The goal of this realignment was to enhance share 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. We believe Danielza has the potential to penetrate the U.S. market even further and increase physician utilization in high-risk relapsed refractory neuroblastoma in bone and or bone marrow.

As you heard earlier, we recorded total Daniela <unk> net product revenues of $20 9 million in the first quarter of 2025.

Speaker Change: And we look forward to working with these sites going forward.

Pete: Representing an 8% increase.

Pete: Compared to $19 4 million.

Pete: Total danielson net product revenues in the first quarter of 2024.

Pete: The increase was primarily due.

Pete: Fueling increased ex U S net product revenues.

Speaker Change: Let's now take a look at some commercial highlights in the first quarter of 2025.

Pete: $6 7 million.

Pete: Which was partially offset by $5 2 million decrease in U S. Daniels with net product revenues for the first quarter of 2025.

Speaker Change: We're pleased to have achieved the upper end of our first quarter guidance with total net Daniels product revenues of $20 $9 million in the first quarter of 2025, and 8% increase compared to the prior year period.

Pete: Compared to the first quarter of 2024.

Doug Gentilcore: 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 Y-mAbs differentiated anti-GT2 therapy. We see this as a real opportunity to add additional high-volume institutions and grow Danielza's market share.

Pete: Ex U S. Net product revenues were $7 5 million and <unk> 8 million for the three months ended March 31, 2025, and 2024, respectively representing.

Pete: Representing an 816% increase.

Pete: The increase in ex U S. Net product revenues was driven by named patient program in Western Asia.

Speaker Change: In the U S. Total net product revenues for the first quarter were $13 $4 million down 28% from the prior year period. The decrease was driven by a number of factors.

Pete: It was launched in late 2024.

Pete: And an increase in net product sales in Eastern Asia, and Latin America.

Doug Gentilcore: We are excited to be kicking off a new Nexidemab 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 Nexidemab and other indication and lines of treatment. And we look forward to working with these sites going forward. We believe this activity, in combination with our ongoing work with the BEAT Childhood Cancer Consortium, or BCC, and the new approaches to Neuroblastoma Treatment Consortium, or NANTS, will further grow Danielza's utilization and expand our market reach.

Speaker Change: Coming out of the end of 2024 and into the first quarter of 2025. The company saw a new patient enrollments 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 and contribute to the year over year.

Pete: We did not have any licensing revenue for the three months ended March 31, 2025 and.

Pete: And we recorded <unk> 5 million of licensing revenue in the three months ended March 31 2024.

Pete: Research and development expenses were $11 4 million and $13 3 million for.

Speaker Change: U S revenue decrease.

For the quarters ended March 31, 2025, and 2024, respectively.

Speaker Change: As part of our business unit realignment, we have focused our Daniels our commercial operations around accelerating our advocacy development, increasing new patient starts expansion into new high volume commercial accounts and highlighting financial advantages of Danielle.

Pete: The one 9 million decrease in research and development expenses was primarily attributable to a decrease of <unk> 7 million in clinical trials.

Doug Gentilcore: We look forward to sharing these updates on these new partnerships as activities progress.

Speaker Change: All three of these areas of focus have shown positive returns towards the end of the first quarter and into the second quarter of 2025.

Pete: Due to the timing of completion in our phase one <unk> trial <unk> one.

Doug Gentilcore: Let's now take a look at some commercial highlights in the first quarter of 2025. We are pleased to have achieved the upper end of our 1st quarter guidance with total net Danielza product revenues of $20.9M in the 1st quarter of 2025, an 8% increase compared to the prior year period. Ex-USA Danielza net product revenues were 7.5M dollars, an increase of 6.7M dollars compared to the prior year period, driven primarily by our name patient program in Western Asia, which launched in late 2024, as well as product growth in Eastern Asia and Latin America.

Pete: Investment in our ongoing programs.

Speaker Change: One key updates since our last call that <unk> in combination with chemotherapy has been added to the NCC guidelines for the treatment of relapsed or refractory neuroblastoma with Daniels are now included in the NCC guidelines. We believe this will lead to even more support and interest in our differentiated therapy for relapsed refractory high risk <unk>.

Pete: And $8 $9 million decrease in personnel and stock based compensation costs.

Pete: Partially offset by <unk> 6 million increase in outsource manufacturing and investment.

Pete: In our <unk> program.

Pete: Selling and general administrative expenses increased $1 7 million.

Pete: $13 1 million for the quarter ended March 31 2025.

Pete: Compared to $11 4 million in the same period of 2024.

Doug Gentilcore: In the U.S., total net product revenues for the first quarter were $13.4 million, down 28% from the prior year period. The decrease was driven by a number of factors. Coming out of the end of 2024 and into the first quarter of 2025, the company saw new patient enrollment slow largely due to competitive pressure from high enrollment of patients in clinical studies and competitive market dynamics, including continued use of available maintenance therapy. Additionally, some of our largest customers ordering patterns contribute to the year over year US revenue decrease.

Speaker Change: I'll hand, the call over to Pete for a broader financial update.

Pete: The $1 7 million increase in selling general and administrative expenses.

Pete: Thank you, Doug and good morning, everyone.

Daniela: You heard earlier, we recorded total Daniela <unk> net product revenues of $20 9 million in the first quarter of 2025.

Pete: Was primarily attributable to a <unk> 8 million increase in personnel and stock based compensation costs.

Pete: Eight 5 million charge related to our business realignment.

Daniela: Representing an 8% increase compared to $19 4 million.

Pete: And a $4 million increase in legal expenses recorded in the three months ended March 31 2025.

Daniela: Hello, Daniela <unk> net product revenues in the first quarter of 2024.

Daniela: The increase was primarily due.

We have reported a net loss for the quarter ended March 31, 2025, or $5 2 million.

Daniela: <unk> increased ex U S net product revenues.

Doug Gentilcore: 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. All three of these areas of focus have shown positive returns towards the end of the first quarter and into the second quarter of 2020.

$6 7 million.

Daniela: Which was partially offset by $5 2 million decrease in U S. Daniels in net product revenues for the first quarter of 2025.

Pete: Were a negative <unk> 12 per basic and diluted share.

Pete: As compared to a net loss of $6 6 million.

Daniela: Compared to the first quarter of 2024.

Pete: Negative <unk> 15 per basic and diluted share.

Daniela: Ex U S. Net product revenues were $7 5 million and $8 million for the three months ended March 31, 2025, and 2024, respectively representing.

Pete: For the quarter ended March 31 2024.

Pete: The decrease in net loss for the quarter ended March 31, 2025 was primarily driven by an increase in net product revenues.

Doug Gentilcore: One key update since our last call is that Danielza, in combination with chemotherapy, has been added to the NCCN guidelines for the treatment of relapse 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 relapsed refractory high-risk neuroblasts. 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.

Daniela: Representing an 816% increase.

Pete: A favorable impact from foreign currency transactions.

Daniela: The increase in ex U S net product revenues.

Pete: With our business unit realignment strategy announced in January of this year.

Daniela: It was driven by named patient program in Western Asia, which was launched in late 2024.

Pete: We have now organized.

Daniela: And an increase in net product sales in Eastern Asia, and Latin America.

Pete: <unk> internal business units.

Pete: Daniela and Radiopharmaceuticals.

Pete: Our business units are focused on different products and platforms.

Daniela: We did not have any licensing revenue for the three months ended March 31, 2025 and.

Pete: They're managed separately as business units require.

Daniela: And we recorded <unk> 5 million of licensing revenue.

Peter Pfreundschuh: With that, I'll hand the call over to Pete for a broader financial update. Thank you, Doug, and good morning, everyone. As you heard earlier, we recorded total Danielle VidNet product revenues of $20.9 million in the first quarter of 2025. representing an 8% increase compared to $19.4 million total Daniels in net product revenues in the first quarter of 2024. The increase was primarily due to an increased ex-U.S. net product revenues. $6.7 million. Which was partially offset by $5.2 million decrease in U.S. Daniels and Net Product revenues for the first quarter of 2025 compared to the first quarter of 2024.

Pete: And also required different research development marketing and operational investments.

Daniela: In the three months ended March 31 2024.

Pete: Our segment profit and losses from operations also includes certain noncash costs.

Daniela: Research and development expenses were $11 4 million and $13 3 million for.

Daniela: For the quarters ended March 31, 2025, and 2024, respectively.

Pete: Our Daniels a business unit.

Pete: Next a segment profit from operations of $8 8 million.

Daniela: The one 9 million decrease in research and development expenses was primarily attributable to a decrease of <unk> 7 million in clinical trials.

Pete: Which was a 42% segment profit margin.

Pete: Based on total revenues of $20 9 million for the first quarter of 2025.

Daniela: Due to the timing of completion in our phase one <unk> trial <unk> one.

Pete: Segment profit from operations during the first quarter of 2024.

Pete: Was $8 7 million or.

Daniela: Investment in our ongoing programs.

Pete: Over 44% segment profit margin based on total revenues of $19 9 million.

Daniela: And $8 $9 million decrease in personnel and stock based compensation costs.

Pete: Our Radiopharmaceuticals business unit.

Daniela: Partially offset by <unk> 6 million increase in outsource manufacturing and investment.

Peter Pfreundschuh: Ex-U.S. net product revenues were $7.5 million and $0.8 million for the three months ended March 31, 2025 and 2024, respectively, representing an 816 percent increase. The increase in ex-U.S. net product revenues was driven by a named patient program in Western Asia, which was launched in late 2024, and an increase in net product sales in Eastern Asia and Latin America.

Pete: It reflects a segment loss or investment from operations.

Daniela: And our next <unk> program.

Pete: $6 1 million and $6 million for the first quarters of 2025 and 2024, respectively.

Daniela: Selling and general and administrative expenses increased $1 7 million for <unk>.

$13 1 million for the quarter ended March 31 2025.

Pete: As mentioned earlier, we ended the first quarter of 2025 with cash and cash equivalents of $60 3 million.

Daniela: <unk> to $11 4 million in the same period of 2024.

Daniela: The $1 7 million increase in selling general and administrative expenses was primarily attributable to a <unk> 8 million increase in personnel and stock based compensation costs.

Pete: As compared to $67 2 million.

Pete: Year ended 2024.

Pete: Representing an investment of $6 9 million for the first quarter of 2025.

Peter Pfreundschuh: We did not have any licensing revenue for the three months ended March 31st, 2025, and we recorded 0.5 million of licensing revenue in the three months ended March 31st, 2024. Research and development expenses were $11.4 million and $13.3 million, where the quarters ended March 31, 2025 and 2024, respectively. The $1.9 million decrease in research and development expenses was primarily attributable to a decrease of $0.7 million in clinical trials. Due to the timing of completion in our Phase 1 GD2 SADA Trial 1001, Investing in our ongoing SADA-approved programs. and a $0.9 million decrease in personnel and stock-based compensation costs.

Pete: The company continues to be capital efficient.

Daniela: $8 5 million charge related to our business realignment.

Pete: And we are currently operating below our anticipated cash investment guidance for the full year of 2025.

Daniela: A $4 million increase in legal expenses recorded in the three months ended March 31 2025.

Pete: Turning now to our full year 2025 guidance, we reiterate our anticipated full year 2025, total revenue operating expenses and cash investment.

Daniela: We have reported a net loss for the quarter ended March 31 2025.

Daniela: A $5 2 million.

Daniela: Were a negative <unk> 12 per basic and diluted share.

Pete: As well as our ability to fund operations as currently planned into 2027.

Daniela: As compared to a net loss of $6 6 million.

Pete: In addition, we are also announcing guidance for our second quarter of 2025 total revenue.

Negative <unk> 15 per basic and diluted share.

Daniela: For the quarter ended March 31 2024.

Pete: Which is expected to be between the range of $17 million and $19 million.

Daniela: The decrease in net loss for the quarter ended March 31, 2025 was primarily driven by an increase in net product revenues.

Pete: This guidance range aligns with our second quarter trends in prior years.

Pete: Excluding stocking orders.

Daniela: And a favorable impact from foreign currency transactions.

Peter Pfreundschuh: Partially offset by a $0.6 million increase in outsource manufacturing and investment in our Nexidimab program. Building and general administrative expenses increased $1.7 million to $13.1 million for the quarter ended March 31, 2025, compared to $11.4 million in the same period of 2024. The $1.7 million increase in selling general and administrative expenses was primarily attributable to a $0.8 million increase in personal and stock-based compensation costs $8.5 million charge related to our business realignment. And a 0.4 million increase in legal expenses recorded in the three months ended March 31st, 2025. We have reported a net loss for the quarter-ended March 31, 2025, of $5.2 million, or a negative $0.12 per basic and diluted chair.

Pete: The company is committed to providing guidance numbers that are realistic.

Daniela: With our business unit realignment strategy announced in January of this year.

Pete: Finally, I want to provide some color around potential tariffs that may impact our organization.

Daniela: We have now organized.

Daniela: <unk> internal business units.

Pete: Daniels's manufactured both in the U S and outside the U S. Today.

Daniela: Daniela and Radiopharmaceuticals.

Daniela: Our business units are focused on different products and platforms.

Pete: We conducted an analysis of our supply chain to understand the potential exposure to tariffs.

Daniela: They're managed separately as business units require.

Pete: At this moment, we anticipate that potential tariff increases.

Daniela: And also required different research development marketing and operational investments.

Pete: Have a minimal impact on why maps.

Daniela: Our segment profit and losses from operations also includes certain noncash costs.

Pete: We're continuing to monitor geopolitical developments as they evolve.

Pete: With a strong balance sheet and a focused business unit strategy.

Our Daniels a business unit.

Daniela: Next a segment profit from operations of $8 8 million.

Pete: We believe <unk> is well positioned to execute our strategic mission and priorities.

Daniela: Which was a 42% segment profit margin.

Pete: And to support the delivery of multiple anticipated milestones in the year ahead.

Based on total revenues of $20 9 million for the first quarter of 2025.

Pete: This concludes the financial update.

Mike: And now I'll turn the call back over to Mike.

Daniela: Segment profit from operations during the first quarter of 2024.

Mike: Thank you Pete.

Speaker Change: Now, let's open the line for questions operator.

Daniela: $8 7 million or.

Speaker Change: Thank you to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Daniela: Over 44% segment profit margin based on total revenues of $19 9 million.

Peter Pfreundschuh: As compared to a net loss. 6.6 million. For a negative 15 cents per basic and diluted chair for the quarter ended March 31st, 2024. The decrease in net loss for the quarter ended March 31st, 2025, was primarily driven by an increase in net product revenues. Any favorable impact from foreign currency transactions.

Daniela: Our Radiopharmaceuticals business unit.

Speaker Change: We ask that you please limit to one question and one follow up.

Daniela: Reflects a segment loss or investment from operations.

Daniela: $6 1 million and $6 million for the first quarters of 2025 and 2024, respectively.

Nicole: And the first question comes from Nicole <unk> with true with your line is now open.

Nicole: Good morning, and thanks for taking my question.

Daniela: As mentioned earlier, we ended the first quarter of 2025 with cash and cash equivalents of $60 3 million.

Speaker Change: No for Danielle that can you just help us better understand how to think about the U S and ex U S revenue dynamics and what are the push and pulls that get us to the higher end of the range.

Peter Pfreundschuh: 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. They are managed separately as business units require. and also require different research, development, marketing, and operational investment. Their segment profit and losses from operations also include certain non-cash costs. Our Daniela business unit reflects a segment profit from operations of $8.8 million. which was a 42% segment profit margin based on total revenues of $20.9 million for the first quarter of 2025. Segment profit from operations during the first quarter of 2024 was $8.7 million or 44% segment profit margin based on total revenues of $19.9 million.

Daniela: As compared to $67 2 million.

Nicole: Okay.

Daniela: At year ended 2024, representing.

Nicole: Nicole Thank you very much.

Daniela: Representing an investment of $6 9 million for the first quarter for 2025.

Nicole: I'll turn it over to Doug Doug can address.

Doug: So I'll tell you as we continue to see steady growth.

Daniela: The company continues to be capital efficient.

And we are currently operating below our anticipated cash investment guidance for the full year of 2025.

Doug: Moderate growth with our partners, but we didn't have this quarter with some of the stock ins that we had had previous quarters. So we continue to see success and growth outside of the U S, including new starts throughout Asia, and the middle East and the U S. We.

Daniela: Turning now to our full year 2025 guidance, we reiterate our anticipated full year 2025.

Daniela: Revenue operating expenses and cash investment.

Doug: Continue to see pricing.

Doug: Price increase and slower start to the quarter, but we have seen through the end of the first quarter into the second quarter, an uptick in enrollments and really getting back on track from a.

Daniela: As well as our ability to fund operations as currently planned into 2027.

Daniela: In addition, we are also announcing guidance for our second quarter of 2025 total revenue.

Doug: Revenue standpoint, most specifically around new starts which is our primary focus.

Daniela: Which is expected to be between the range of $17 million and $19 million.

Doug: Aside from that yes, we're seeing what we're essentially expecting.

Daniela: This guidance range aligns with our second quarter trends in prior years, excluding stocking orders.

Doug: Both in and outside the U S.

Peter Pfreundschuh: A radiopharmaceuticals business unit reflects a segment loss or investment from operations. of $6.1 million and $6 million for the first quarters of 2025 and 2024, respectively. As mentioned earlier, we ended the first quarter of 2025 with cash and cash equivalents. $60.3 million as compared to $67.2 million. at year-ended 2024, representing an investment of $6.9 million for the first quarter of 2025. The company continues to be capitally efficient. And we are currently operating below our anticipated cash investment guidance for the full year of 2025.

We continue to see when the 80 2070 30 rule with U S. Ex U S and that continues to continues all tool for us.

Daniela: The company is committed to providing guidance numbers that are realistic.

Daniela: Finally, I want to provide some color around potential tariffs.

Speaker Change: Okay, and then just one quick follow up on.

Daniela: The impacts of our organization.

Daniela: Daniels's manufactured both in U S and outside the U S. Today.

Speaker Change: Your competitor Andy what do you do you see any more switching dynamics, there or can you help us understand the switching dynamics and how that's going to evolve for the rest of the year and longer term.

Daniela: We conducted an analysis of our supply chain to understand the potential exposure to tariffs.

Daniela: At this moment, we anticipate that potential tariff increases.

Speaker Change: Yes, Nicole we continue to to.

Daniela: Would have a minimal impact on why maps.

Speaker Change: Yes.

Speaker Change: Try to expand within our current accounts as well as targeting.

Daniela: We're continuing to monitor geopolitical developments as they evolve.

Speaker Change: 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.

Daniela: With a strong balance sheet and a focused business unit strategy.

Daniela: We believe <unk> is well positioned to execute our strategic mission and priorities.

Daniela: To support the delivery of multiple anticipated milestones in the year ahead.

Speaker Change: Giving us a tailwind on that side of going after some market share that we havent captured.

Peter Pfreundschuh: 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.

Daniela: This concludes the financial update.

Mike: And now I'll turn the call back over to Mike.

Speaker Change: Great. Thank you so much.

Mike: Thank you Pete.

Speaker Change: And the next question will come from Mike <unk> with Morgan Stanley. Your line is open.

Mike: Now, let's open the line for questions operator.

Speaker Change: Thank you to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

Speaker Change: Good morning, Thanks for taking the question maybe just another one on Danielle.

Speaker Change: It looks like your <unk> revenue guidance does imply a little bit of a down trend in <unk> over <unk>, you mentioned some sort of.

Peter Pfreundschuh: In addition, we are also announcing guidance for our second quarter of 2025 total revenue. which is expected to be between the range of $17 million and $19 million. This guidance range aligns with our second quarter trends in prior years, excluding stocking orders. The company is committed to providing guidance numbers that are realistic.

Speaker Change: We ask that you please limit to one question and one follow up.

Speaker Change: Historical trends there, maybe just talk a little bit more about that and how to think about the progress in <unk>. Thanks.

Nicole: And the first question comes from Nicole <unk> with true with your line is now open.

Good morning, and thanks for taking my question.

Speaker Change: Yes, Mike as we look at this there is seasonality within the products and what we're forecasting for that also as you look at U S versus international very strong start on the <unk> side in the first quarter. So as the guidance goes out I think it's realistic for us to look at this <unk>.

Speaker Change: No for Danielle that can you just help us better understand how to think about the U S and ex U S revenue dynamics and what are the push and pulls that get us to.

Peter Pfreundschuh: Finally, I want to provide some color around potential tariffs that may impact our organization. Vinyals is manufactured both in the U.S. and outside the U.S. today. We conducted an analysis of our supply chain to understand the potential exposure to tariffs. At this moment, we anticipate that potential tariff increases would have a minimal impact on Y-MAP. We're continuing to monitor geopolitical developments as they evolve.

Nicole: To the higher end of the range.

Nicole: Okay.

Nicole: Nicole Thank you very much.

Nicole: I'll turn it over to Doug and Doug can address.

Speaker Change: And both the seasonality as well as.

Speaker Change: The international.

Nicole: So I'll tell you as we continue to see steady growth I would say a moderate growth with our partners, but we didn't have this quarter with some of the stock ins that we had had previous quarters. So we continue to see success and growth outside of the U S, including new starts throughout Asia and the middle.

Speaker Change: Prevalent pool of patients.

Speaker Change: Where we have treated multiple patients in Q1 that won't be available.

Mike: Yes, Mike I'll add a little bit more texture to your question as well on top of what Mike said so.

Peter Pfreundschuh: With a strong balance sheet and a focused business unit strategy, we believe Y-mAbs is well positioned to execute our strategic mission and priorities. and to support the delivery of multiple anticipated milestones in the year ahead.

Mike Rossi: If you look at our U S sales for last year in the second quarter.

Nicole: <unk> in the U S. We.

Mike: We did $15 $2 million.

Nicole: Continue to see.

Nicole: Price increase and slower start to the quarter, but we have seen through the end of the first quarter into the second quarter, an uptick in enrollments and really getting back on track from a.

Mike: Well, we're kind of projecting is kind of U S to be slightly up quarter on quarter year over year.

Peter Pfreundschuh: This concludes the financial update.

Peter Pfreundschuh: And now I'll turn the call back over. Thank you, Pete.

Mike: Ex U S second quarter 2024, we had a lot of stock and so I think that alludes to <unk> earlier comment that was made.

Nicole: Revenue standpoint, most specifically around new starts which is our primary focus.

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

Operator: To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We ask that you please limit to one question and one follow-up.

Mike: If you look at second quarter 2024, we had about almost $5 million of stock gains in Western Europe, Latin America Eastern Asia.

Nicole: Aside from that yes, we're seeing what we're essentially expecting.

Nicole: Both in and outside of the U S.

Nicole: Nicole we continue to see when the 80 2070 30 rule with U S. Ex U S and that continues to continues to hold true for us.

Mike: We don't anticipate those tuck ins in the second quarter of this year. So when you kind of do the math on that that really comes back to our guidance range of $17 million to $19 million.

Nicole Germino: And the first question comes from Nicole Germino with Truist. Your line is now open. Good morning and thanks for taking my question. For Daniela, can you just help us better understand how to think about the U.S. and ex-U.S. revenue dynamics and what are the push and pulls that get us to the higher end of the range? Nicole, thank you very much.

Speaker Change: Okay, Great and then just one quick follow up on.

I would stress like you can kind of see with first quarter guidance. We're trying to provide you guys with the next quarter's guidance every quarter.

Your competitor Andy what do you do you see any.

Speaker Change: More switching dynamics, there or can you help us understand the switching dynamics and how that's going to evolve for the rest of the year and longer term.

Mike: 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 landed 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 Change: Yes, Nicole we continue to to.

Speaker Change: Yes.

Speaker Change: Try to expand within our current accounts as well as targeting.

Doug Gentilcore: I'll turn that over to Doug, and Doug can address the rest of it. So, outside of the U.S., we continue to see steady growth, I'd say moderate growth, with our partners. But we didn't have this quarter with some of the stock-ins that we had had previous quarters. So, we continue to see success and growth outside of the U.S., including new starts throughout Asia and the Middle East. In the U.S., we continue to see price increase and slower start to the quarter. But we have seen through the end of the first quarter, 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.

Mike: Coming back to an earlier question full year, we still are very convinced with regards to the $75 million to $90 million overall guidance range.

Speaker Change: Giving us a tailwind on that side of.

Speaker Change: Going after some market share that we havent captured.

Mike: We still believe we're going to land in that zone.

Speaker Change: Great. Thank you so much.

Mike: Things are looking good for the full year I think as we view that the U S will start to rebound debate for US based upon a lot of great work, that's going on in the company around the business unit realignment and specifically daniels's. So.

Mike: And the next question will come from Mike <unk> with Morgan Stanley. Your line is open.

Speaker Change: Oh good morning, Thanks for taking the question maybe just another one on Danielle.

Speaker Change: It looks like your <unk> revenue guidance does imply a little bit of a down trend in <unk> over <unk>, you mentioned some sort of.

Mike: As you guys think about your models just adjust them accordingly.

Mike: As you think about kind of the second half of the year hopefully that helps Mike.

Speaker Change: Historical trends there, maybe just talk a little bit more about that and how to think about the progress in <unk>. Thanks.

Speaker Change: Very helpful. Thanks for the additional color.

Doug Gentilcore: Aside from that, yeah, we're seeing what we're essentially expecting, both in and outside of the U.S. And, Nicole, we continue to see the 80-20-70-30 rule with U.S. x U.S., and that continues to alter for us.

Mike: Yep.

Speaker Change: And the next question comes from Justin Walsh with Jones trading your line is open.

Mike: Yes, Mike.

Mike: We look at this there is seasonality within the products and what we're forecasting for that also as you look at U S versus international very strong start on the <unk> side in the first quarter. So as the guidance goes out I think it's realistic for us to look at this and factor in both the seasonality as well as.

Justin Walsh: Hi, Thanks for taking my question I'm wondering if you can comment on any current plans for <unk> and osteosarcoma.

Nicole Germino: Okay, great.

Speaker Change: Yes, we continue to support asset Coenosteum sarcoma also.

Nicole Germino: And just one quick follow-up on your competitor in the U.S.

Doug Gentilcore: Do you see any more switching dynamics there, or can you help us understand those switching dynamics and how that's going to evolve for the rest of the year and longer term? 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 a tailwind on that side of going after some market share that we haven't captured.

Speaker Change: Looking at the potential developing a better diagnostic to determine <unk> two expression.

Mike: The international.

Mike: Prevalent pool of patients.

Speaker Change: Two is very difficult as you look at the challenges around having an IAC for that so we've learned a lot and R. R. <unk> one trial.

Mike: Where we have treated multiple patients in Q1 that won't be available.

Mike: Sure.

Mike: Yes, Mike I'll add a little bit more texture to your question as well on top of what Mike said so.

Speaker Change: On the <unk> two so with that I think we'll be able to accelerate development with better patient selection and are still sarcoma.

Mike: If you look at our U S sales for last year in the second quarter.

Mike: We did $15 $2 million.

Speaker Change: Great. Thanks for taking my question.

Mike: Well, we're kind of projecting is kind of U S to be slightly up quarter on quarter year over year.

Speaker Change: Thanks helpful.

Speaker Change: The next question comes from Lee <unk> with Cantor Your line is open.

Mike: Ex U S second quarter 2024, we had a lot of stock and so I think that alludes to earlier comment that was made.

Speaker Change: Hi, good morning, Thanks for taking our question maybe just on.

Nicole Germino: Great.

Nicole Germino: Thank you so much.

Mike Ulz: And the next question will come from Mike Ulz with Morgan Stanley. Your line is open. Good morning. Thanks for taking the question. Maybe just another one on Danielsa. Looks like your 2Q revenue guidance does imply a little bit of a downtrend in 2Q over 1Q. You mentioned some sort of You know, historical trends there, maybe just talk a little bit more about that and how to think about progress. 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 U.S. versus international, very strong start on the ex-U.S.

Speaker Change: CD 38.

Speaker Change: Looks like you.

Mike: If you look at second quarter 2024, we had about almost $5 million of stock gains in Western Europe, Latin America Eastern Asia.

Speaker Change: First patients are wondering if you can just share some of the key talents at the park in terms of this.

Speaker Change: Number of patients wanting rolla and dosing regimen there.

Mike: We don't anticipate those tuck ins in the second quarter of this year. So when you kind of do the math on that.

Speaker Change: And then just in terms of how should we think about the timeline to data.

Mike: Really comes back to our guidance range of $17 million to $19 million.

Speaker Change: What would be the right benchmark here should we think that you might need some more time with you and <unk> to where it might be a little shorter.

Speaker Change: I would stress Mike you can kind of see with first quarter guidance. We're trying to provide you guys with the next quarter's guidance every quarter.

Speaker Change: Yes, thank you very much for that.

Speaker Change: 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 landed 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.

To have a much deeper dive on our radiopharmaceutical platform on the 28.

Mike Ulz: side in the first quarter. So, you know, as the guidance goes out, I think it's realistic for us to look at this and factor in both the seasonality as well as the international side. prevalence pool of patients where we have treated multiple patients and Q1 that won't be available.

Speaker Change: But just to give you a little bit of color, we dose the first patient.

Speaker Change: It is a smaller overall subset of patients than we were looking at for RGB too.

Speaker Change: But it is a very challenging.

Speaker Change: Indication in the relapse refractory non hodgkins to recruit patients. That's why I was a bit challenging in finding the right patients to dose under for us.

Speaker Change: Coming back to an earlier question full year, we still are very very convinced with regards to the $75 million to $90 million overall guidance range.

Mike Ulz: 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 US sales for last year in the second quarter, We did $15.2 million. What we're kind of projecting is kind of U.S. to be slightly up quarter-on-quarter, year-over-year. Ex-U.S., second quarter 2024, we had a lot of stock-ins. I think that alludes to an earlier comment that was made. If you look at second quarter 2024, we had about almost $5 million of stock-ins in Western Europe, Latin America, and Eastern Asia. We don't anticipate those stock-ins in the second quarter of this year, so when you kind of do the math on that, that really comes back to a guidance range of $17 to $19 million.

Speaker Change: <unk>.

Speaker Change: We still believe we're going to land in that zone.

Speaker Change: It's a platform safety study.

Speaker Change: So with that we're looking at ways to accelerate it but right now the plan is in around 12 to 15 patients.

Speaker Change: Things are looking good for the full year I think as we view that the U S will start to rebound debate for US based upon a lot of great work, that's going on in the company around the business unit realignment and specifically Daniels us so.

Speaker Change: So it is less patients than we saw in <unk>.

Speaker Change: In the Tivo one trial.

Speaker Change: Thank you.

Speaker Change: As you guys think about your models just adjust them accordingly.

Speaker Change: Thank you Lee.

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

Speaker Change: As you think about kind of the second half of the year hopefully that helps Mike.

John Newman: Hi, guys. Thanks for taking my question just had kind of a.

Speaker Change: Very helpful. Thanks for the additional color.

John Newman: Financial question here, just curious if there was any effect from a Medicaid reserve perspective this quarter.

Speaker Change: Yep.

Speaker Change: And the next question comes from Justin Walsh with Jones trading your line is open.

John Newman: I know in the past there've been some adjustments, but not sure. If there was anything in the first quarter.

Justin Walsh: Hi, Thanks for taking my question I'm wondering if you can comment on any current plans for <unk> and osteosarcoma.

John Newman: Yes, John I appreciate it I'll turn it over to Pete.

John Newman: To give you some clarity on that.

Speaker Change: Yes, we continue to support I ask this in osteosarcoma also.

Speaker Change: John Great question as you know from some prior quarters, we've had some adjustments as we've done quarter on quarter.

Mike Ulz: 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-in seasonality, various other things, so that we actually can kind of land in the range that we're projecting. We feel very comfortable. Again, I think as we alluded to in the script, we're just trying to be realistic about guidance. Coming back to an earlier question, full year, we still are very convinced with regards to the $75 to $90 million overall guidance range.

Justin Walsh: Looking at the potential drill thing.

Speaker Change: 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 Medicaid 340 <unk>.

Justin Walsh: <unk> diagnostic to determine <unk> two expression GDT was very difficult as you look at the challenges around having an IAC for that so we've learned a lot and our our <unk> trial.

Speaker Change: Gross to net elements.

Speaker Change: No.

Speaker Change: We don't anticipate major changes as we go forward kind of in 2025, I know, we had some more significant adjustments in 2024 and various quarters.

Justin Walsh: On the <unk> two so with that I think we'll be able to accelerate development with better patient selection in our sarcoma.

Speaker Change: Great. Thanks for taking my question.

Speaker Change: But again, we're starting to see some stabilization I think.

Justin Walsh: Thanks helpful.

Lee: The next question comes from Lee <unk> with Cantor Your line is open.

Speaker Change: Some of that especially the 340 b is associated with a bit more of the revenue shift to outside certain institutions, where they actually have patience.

Mike Ulz: We still believe we're going to land in that zone. Things are looking good for the full year. I think as we view that, the U.S. will start to rebound a bit for us based upon a lot of great work that's going on in the company around the business unit realignment, and specifically Danielza, so as you guys think about your models, just adjust them accordingly as you think about kind of the second half of the year. Hopefully that helps, Mike. No, very helpful. Thanks for the additional color.

Speaker Change: Hi, good morning, Thanks for taking our question maybe just on.

Lee: CD 38.

Speaker Change: And $3 40 bank so.

Speaker Change: Looks like you.

Speaker Change: And then on the Medicaid side again stabilization. So overall I think the answer is 2025, we don't anticipate any major kind of adjustments.

Lee: First patients.

Lee: Wondering if you can just share some of the key talents into part in term.

Lee: Number of patients wanting Val and dosing regimen there.

Lee: And then just in terms of how should we think about the timeline to data.

Speaker Change: At this time so hopefully.

Speaker Change: Hopefully that helps you.

Speaker Change: Yes. Thank you.

Lee: What would be the right benchmark here should we think.

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

Lee: You might need some more time with you and take <unk> to where it might be a little shorter.

Justin Walsh: And the next question comes from Justin Walsh with Jones Trading. Your line is open. Hi, thanks for taking the question. I'm wondering if you can comment on any current plans for maxidermab in osteosarcoma. Yeah, we continue to support IHS with synostial sarcoma. Also, looking at the potential of developing a better diagnostic to determine GD2 expression. GD2 is very difficult as you look at the challenges around having an IHC for that. So, you know, we've learned a lot in our 10-01 trial on the SADA-GD2. So with that, I think we'll be able to accelerate development with better patient selection and synostial sarcoma.

Jeff Jones: Good morning, guys and thanks for taking the question.

Lee: Lee Thank you very much for that.

Speaker Change: Mike You mentioned.

Speaker Change: Looking at a new construct for GTT sada to improve tumor uptake.

Lee: They have a much deeper dive on our radiopharmaceutical platform on the 28, but.

Speaker Change: But just to give you a little bit of color, we dosed the first patient.

Speaker Change: How does that impact the plan and move forward with the part B of the study.

Speaker Change: It is a smaller overall subset of patients than we were looking at for <unk>.

Speaker Change: Can you speak to timing and any other impacts thanks.

Speaker Change: But it is a very challenging.

Speaker Change: Indication in the relapsed refractory non hodgkins to recruit patients. That's why it was a bit challenging in finding the right patients to dose under for us.

Jeff Jones: Hey, Jeff I appreciate it good question.

Jeff Jones: Again, just from a topline perspective, what we're looking to do.

Jeff Jones: It is increase the affinity.

Jeff Jones: 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.

Speaker Change: This is <unk>.

The platform safety study.

Speaker Change: So with that we're looking at ways to accelerate it but right now the plan isn't around 12 to 15 patients.

Justin Walsh: Great, thanks for taking the question.

Speaker Change: So it has less patients and we saw him.

Justin Walsh: Thank you.

Jeff Jones: Just to show the <unk>.

Speaker Change: In the Tivo one trial.

Li Watsek: The next question comes from Li Watsek with Canter. Your line is open. Hey, good morning. Thanks for taking our questions. Maybe just on CD38, SELDA, it looks like you're the first patient. I'm wondering if you can just share some of the details of the Part A in terms of the number of patients that you want to enroll and the 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 G2, or it might be a lot of shorter things.

Jeff Jones: Safety incident.

Jeff Jones: Of the new linker and again, it's a proprietary linker for us. So we'll go into as much deeper on the 28.

Speaker Change: Thank you.

Speaker Change: Thank you Lee.

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

Jeff Jones: But what we plan to do is have that.

John Newman: Hi, guys. Thanks for taking my question just had kind of a.

Speaker Change: Our four.

Speaker Change: Second half of this year with essentially being completed.

John Newman: Financial question here, just curious if there was any effect from a Medicaid reserve perspective this quarter.

Speaker Change: Early next year.

Speaker Change: Great. Thank you.

John Newman: I know in the past there've been some adjustments, but not sure. If there was anything in the first quarter.

Speaker Change: Thank you.

Speaker Change: And the next question comes from Belmond with clear Street your line.

Pete: Yes, John I appreciate it I'll turn it over to Pete.

Speaker Change: Yes.

Speaker Change: Hey, good morning, and thanks, so looking beyond quarter to quarter dynamics on Daniels, obviously, there is there sort of a revamped commercial effort on that.

Pete: He can give you some clarity on that.

John Newman: John Great question.

John Newman: You know from some prior quarters, we've had some adjustments as we've done quarter on quarter.

Speaker Change: What needs to happen to return to more robust long term growth and when might we see that tick up.

John Newman: 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 Medicaid 340 B.

Li Watsek: Yeah, Lee, thank you very much for that. We're going to have a much deeper dive on our radiopharmaceutical platform on the 28th, but just to give you a little bit of color, we dosed the first patient. It is a smaller overall subset of patients than we were looking at for our GD2, but it is a very challenging indication in the relapsed refractory non-Hodgkin's tubercle patients. That's why it was a bit challenging in finding the right patients to dose. For us, it's a platform safety study. So with that, we're looking at ways to accelerate it, but right now the plan isn't around 12 to 15 patients.

Speaker Change: Yes.

Speaker Change: Yes, Bill I appreciate that and Thats. The exact reason we went into the key business unit structure and brought in Doug two to execute that so I'll turn it over to Doug and he can share his plans.

John Newman: Gross to net elements.

John Newman: So.

John Newman: So we don't anticipate major changes as we go forward kind of in 2025, I know, we had some more significant adjustments in 2024 and various quarters.

Doug: Yes. So thank you. The first thing that we have been focused on and quite frankly, the business as a whole has been focused on for the last year to 18 months of developing advocates.

John Newman: But again, we're starting to see some stabilization I think.

Doug: Further developing that advocacy to be more vocal in the market. We're starting to see that reflected with the change in the <unk> guidelines are recently announced as well as some of our Kols development starts to really move us back into a position where we are.

John Newman: Some of that especially the $3 40, b is associated with a bit more of a revenue shift to outside certain institutions, where they actually have patients.

John Newman: And 340 <unk>.

Li Watsek: So it is less patients than we saw in the 1001 trial. Thank you.

John Newman: And then on the Medicaid side again stabilization. So it's overall I think the answer is 2025, we don't anticipate any major kind of adjustments at this time, so hopefully that helps you.

Doug: The clinical discussion when it comes to treating these very sick patients. So the first thing starts with advocacy. The second piece is developing stronger financial messaging around Danielle done specifically around outpatient and the benefits of outpatient.

John Newman: And our next question comes from John Newman with Canaccord. Your line is open. Hi, guys. Thanks for taking my question. Just had kind of a financial question here. I'm 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. Yeah, John, I appreciate it.

John Newman: Thank you.

Doug: 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 were.

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

Speaker Change: Good morning, guys and thanks for taking the question Mike You mentioned looking at a new construct for GTT sada to improved tumor uptake.

Doug: Is preferable and viable for Daniels through our partners and where there are growth opportunities. So we continue to <unk>.

Peter Pfreundschuh: I'll turn that over to Pete, and Pete can give you some clarity on that. Yeah, 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 Medicaid 340B, gross-to-net elements. So, you know, we don't anticipate major changes as we go forward kind of in 2025. I know we had some more significant adjustments in 2024 in various quarters, but again, we're starting to see some stabilization. I think some of that, especially the 340B, is associated with a bit more of the revenue shift to outside certain institutions where they actually have patients in 340B.

Speaker Change: How does that impact the planned and move forward with the part B of the study.

Doug: Follow that playbook and again as I said earlier, we're starting to see those results but.

Speaker Change: Can you speak to timing and any other impacts thanks.

Doug: Average it really starts and ends with advocacy and again, we see that change in the <unk> guidelines as a direct reflection of how we have moved the advocacy needle in our favor.

Jeff Jones: Hey, Jeff I appreciate the good questions.

Speaker Change: Again, just from a topline perspective, what we're looking to do.

Jeff Jones: It is increase the affinity.

Speaker Change: Thanks, and just to up with a radiotherapy question.

Jeff Jones: Two the receptor as well as the duration.

Speaker Change: Obviously initial experience in the in the clinic is useful but also thinking through translate ability to the rest of the B radiotherapy pipeline given Judy too is obviously a different target. It's a different tissue. Then then CD 38 and <unk>.

Jeff Jones: 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 D.

Jeff Jones: Just to show.

Jeff Jones: The safety and effectiveness.

Jeff Jones: Of the new linker and again, it's a proprietary linker for us. So we will go into as much deeper on the 28.

Speaker Change: Other targets that maybe announcement a couple of weeks how much how translatable are your learning so far on the <unk> program to the rest of the platform. Thank you.

Jeff Jones: But what we plan to do is have that.

Jeff Jones: Our core in the second half of this year with essentially being completed.

John Newman: And then on the Medicaid side, again, stabilization. So, overall, I think the answer is, you know, 2025, we don't anticipate any major kind of adjustments at this time. So, okay. Hopefully that helps. Thank you. Yes, thank you.

Speaker Change: Yes.

Speaker Change: Yes. Another good question Bill and we will definitely get into that in a much deeper way, but what the changes were making any advances we're making our platform related so as we learn from the <unk> 38.

Jeff Jones: Early next year.

Jeff Jones: Great. Thank you.

Jeff Jones: Thank you.

Speaker Change: And the next question comes from Belmond with clear Street your line.

Speaker Change: When you go from an N of one two and end of two and as we add additional products and looking at our preclinical <unk> clinical data. The changes we make will be platform wide. So as we move to.

Jeff Jones: Yes.

Jeff Jones: Hey, good morning, and thanks, so looking beyond quarter to quarter dynamics on Daniel's.

Jeff Jones: And the next question comes from Jeff Jones with Oppenheimer. Your line is open. Good morning, guys, and thanks for taking the question. Mike, you mentioned looking at a new construct for GD2-SATA 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? Jeff, I appreciate it. Good question. Again, just from a top line perspective, what we're looking to do is increase the affinity to the receptor as well as the duration that it sits on the tumor, which will improve the overall uptake.

Jeff Jones: Obviously, there is there sort of a revamped commercial effort on that what needs to happen to return to more robust long term growth and when might we see that tick up.

Speaker Change: Our proprietary linker key later that has a higher affinity and duration on the tumor and that'll be the new platform moving forward. We started with the make a data as a way to get into patients quickly in a very safe way.

Jeff Jones: Thanks.

Speaker Change: Yes, Bill I appreciate that and Thats. The exact reason we went into the key business unit structure.

Speaker Change: Without having two different variables. So we've isolated the safety on the GDP.

Speaker Change: We brought in Doug two to execute that so I'll turn it over to Doug and he can share his plans.

Speaker Change: We're in process on the CD 38, now moving into the proprietary linker and key later it will be the same linker key later combinations by ice until for all of the Sada drugs moving forward. So we have that opportunity as we learn to play it back to all of the future constructs.

Doug: Yes. So thank you. The first thing that we have been focused on and quite frankly, the business as a whole has been focused on for the last year to 18 months in developing advocates and further developing the advocacy to be more vocal in the market. We're starting to see that reflected with the change in the <unk> guidelines or recently announced.

Speaker Change: Great. Thanks.

Doug: As well as some of our Kols development starts to really move us back into a position where we are.

Jeff Jones: There'll be a bridging study that goes on between where we are today and Part B, just to show the safety and affinity of the new linker. And again, it's a proprietary linker for us.

Speaker Change: Thanks, Paul.

Speaker Change: And the next question will come from David <unk> with Wedbush. Your line is open.

Speaker Change: Sure.

Doug: And the clinical discussion when it comes to treating these very sick patients. So the first thing starts with advocacy. The second piece is developing stronger financial messaging around Danielle done specifically around outpatient and the benefits of outpatient.

Speaker Change: Hey, Thanks, most of my questions.

Speaker Change: Actually were previous.

Jeff Jones: And we'll go into this much deeper on the 28th. But what we plan to do is have that out for the second half of this year, with essentially being completed early. Great, thank you.

Speaker Change: Questions, but I had one more relating to the platform I know youll go into more but.

Speaker Change:

Speaker Change: If you're swapping out.

Doug: 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 were.

Speaker Change: The linker to increase.

Speaker Change: Affinity and residence time.

Speaker Change: I have to ask basically why did you open up the <unk>.

Bill Mahan: And the next question comes from Bill Mahan with Clear Street. Your line is open. Hey, good morning, and thanks. So, looking beyond quarter-to-quarter dynamics on Danielza, obviously, there's sort of a revamped commercial effort on that. What needs to happen to return to more robust long-term growth, and when might we see that take up? Yeah, Bill, I appreciate that. And that's the exact reason we went into the key business unit structure and brought in Doug to execute that.

Doug: Is preferable and viable for Daniels through our partners and where there are growth opportunities. So we continue to.

Speaker Change: <unk> 38 of NHL study are you going to swap out to or kind of like.

Speaker Change: Walk me through the reasoning there if you're on.

Follow that playbook and again as I said earlier, we're starting to see those results but.

Speaker Change: Contract too.

Speaker Change: <unk> out of the linker.

Doug: Average it really starts and ends with advocacy and again, we see that change in the <unk> guidelines as a direct reflection of how we have moved the advocacy needle in our favor.

Speaker Change: Improve the sort of targeting a residence time thanks.

Speaker Change: David Good question as we looked at this it was important to get in and establish the safety of the protein so that doesn't change so the CD 38 sada construct.

Speaker Change: Thanks, and just to up with a radiotherapy question.

Doug Gentilcore: So I'll turn it over to Doug and he can share his plans. Yes, so thank you. The first thing that we have been focused on, and quite frankly, the business as a whole has been focused on for the last year to 18 months, is developing advocates and further developing that advocacy to be more vocal in the market. We're starting to see that reflected with the change in the NCCN guidelines that 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 Change: Is the same regardless of what linker key later combination we're using so the entire purpose of both the <unk> and the <unk> is looking at the overall safety of the <unk>.

Speaker Change: Obviously initial experience in the in the clinic is useful but also thinking through translate ability to the rest of the fee radiotherapy pipeline given <unk>. Two is obviously a different target. It's a different tissue. Then then CD 38 and <unk>.

Speaker Change: <unk> platform and similar to the channel one with Gd too you want to have a steel variables possible. So maintaining the naked dota under lutetium gives you that that safety information you need from the CD 38, so that when the safety is established as part of the bridging study.

Speaker Change: Other targets that maybe announcement a couple of weeks how much how translatable are your learning so far on the <unk> program to the rest of the platform. Thank you.

Speaker Change: For the new key later linker that can then be translated back in as an amendment.

Speaker Change: To start looking at that as you advance the product forward for treatment. So again, it's about establishing the safety of the protein about the speed of getting that information and then making the change once you have that variable down that youre confident that theres no safety signals from them appropriately so.

Doug Gentilcore: So the first thing starts with advocacy. The second piece is developing stronger financial messaging around Danielzum, 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. But it really starts and ends with advocacy. And again, we see that change in the NCCN guidelines as a direct reflection of how we have moved the advocacy needle in our favor.

Speaker Change: You go from an N of one two and end of two and as we add additional products and looking at our preclinical <unk> clinical data. The changes we make will be platform wide. So as we move to.

Speaker Change: Okay.

Speaker Change: Thanks, Dave.

Speaker Change: And our next question comes from Ken <unk> with Brookline capital markets. Your line is now open.

Speaker Change: Without having two different variables so we.

Speaker Change: Great. Thank you.

Speaker Change: Isolated the safety on the GDT Sada and we're in process on the CD 38, now moving into the proprietary linker and key later it will be the same linker key later combinations by ice until for all of the Sada drugs moving forward. So we have that opportunity as we learn to play it back to Oliver.

Speaker Change: Are you seeing stabilization in the number of cycles per patient for Daniels Enel.

Doug: Kevin It's a good question Doug.

Speaker Change: The stabilization is.

Bill Mahan: Thanks.

Bill Mahan: And just to follow up with a radiotherapy question, obviously, initial experience in the clinic is useful, but also thinking through translatability to the rest of the radiotherapy pipeline. Given GD2 is obviously a different target, it's a different tissue than CD38 and other targets that may be announced in a couple weeks, how translatable are your learning so far on the GD2 program to the rest of the platform? Thank you. Yeah, that's another good question, Bill, and we'll definitely get into that in a much deeper way. But what the changes we're making, the advances we're making are platform related.

Doug: Relevance.

Speaker Change: Future constructs.

Doug: But I think overall, we see the volumes the remained consistent.

Speaker Change: Great. Thanks.

Speaker Change: Thanks, Paul.

Doug: Each individual facility there are small changes in protocols, but in general we've seen year over year growth in number of vials per patient in the U S. We see similar trends abroad.

David <unk>: And the next question will come from David <unk> with Wedbush. Your line is open.

Speaker Change: Yeah.

Speaker Change: Hey, Thanks, most of my questions.

Speaker Change: Actually were previous.

Doug: 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 MTGE two drugs and making sure that Danielle to has its rightful place in that treatment paradigm. So.

Speaker Change: Questions, but I had one more relating to the platform I know youll go into more but.

Speaker Change: He is.

Speaker Change: If you're swapping out.

Speaker Change: The linker to increase.

Speaker Change: Affinity and residence time.

Doug: While we will continue to support and educate on number and how each individual patient is treated from a number of vial standpoint, our real focus is making sure that they are clinically relevant.

Speaker Change: I have to ask basically why did you open up the <unk>.

Bill Mahan: So, as we learn from the GD2 and CDE38, you know, you go from an N of 1 to an N of 2, and as we add additional products and looking at our preclinical versus our clinical data, the changes we make will be platform wide. So, as we move to a proprietary linker and chelator that has a higher affinity 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. So, we've isolated the safety on the GD2 SADA, and we're in the process on the CD38.

Speaker Change: CD 38, NHL study are you going to swap that out to or kind of like.

Doug: Information is in the hands of the decision makers specifically the clinicians that are treating these patients.

Speaker Change: Walk me through the reasoning there if you're on.

Speaker Change: Contract too.

Speaker Change: Great and just a follow up on your efforts with daniels's. So you.

Speaker Change: Change out of the wind currents.

Speaker Change: Improve the targeting of residents.

Speaker Change: Matt referenced a couple of times, the Investor investigator initiated trial.

Speaker Change: No David Good question as we looked at this it was important to get in and establish the safety of the protein so that doesn't change so the CD 38 sada construct.

Speaker Change: Essentially.

Speaker Change: In the Cogs cognate work.

Speaker Change: Has that trial initiated in how many sites are involved in how many sites are you trying to get involved.

Speaker Change: Is the same regardless of what linker key later combination we're using so the entire purpose of both the <unk> and the <unk>. One is looking at the overall safety of the <unk>.

Bill Mahan: 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 Change: So the.

Speaker Change: Protocols and the setup of the study is in the hands of the investigator, we're just supporting them.

Speaker Change: <unk> platform is similar to the channel one with Gd too you want to have steel variables as possible. So maintaining the naked data on the lutetium gives you that that safety information you need from the CD 38, so that when the safety is established as part of the bridging study.

Speaker Change: This particular this next study will have multiple call facilities involved and they are.

Speaker Change: Key and I would say luminary facilities amongst that group. So we're quite excited about how this study has evolved and develops.

Bill Mahan: Great, thanks. Thanks, Bill.

David Nierengarten: And the next question will come from David Nierengarten with Wedbush. Your line is open. Hey, thanks. Most of my questions actually were the previous questions, but I have one more relating to the platform. I know you'll go into it more, but the if you're swapping out The linker to increase you know, affinity and residence time.

Speaker Change: We do anticipate a.

Speaker Change: Very near term start so hopefully there will be market information available to the market in the very near future.

Speaker Change: For the new key later linker that can then be translated back in as an amendment.

Speaker Change: About the sites and what level of involvement.

Speaker Change: To start looking at that as you advance the product forward for treatment. So again, it's about establishing the safety of the protein above the speed of getting that information and then making the change once you have that variable down that you are confident that theres no safety signals from them appropriately so.

Speaker Change: Great. Thank you so much.

Tim: Thank you Tim.

Speaker Change: And our next question will come from <unk> <unk> with van unless shot Kempen. Your line is open.

Speaker Change: Hello team. Thanks for taking my question congratulation with the progress as well.

David Nierengarten: I have to ask, like, basically, why did you open up the CD38 NHL study? Are you going to swap that out, too, or, you know, kind of, like... You know, walk me through the reasoning there if you're on track to, you know, change out the linker and, you know, improve the SADA, you know, targeting the residence time.

Speaker Change: Okay.

Speaker Change: And one question for me about Daniels and the inclusion in the MTBE and guidelines, but also regarding indeed, the new investigator led.

Dave: Thanks, Dave.

Speaker Change: And our next question comes from Ken <unk> with Brookline capital markets. Your line is now open.

Speaker Change: Trial in collaboration with the Cox advocacy groups I was wondering if you could talk a little bit more.

Speaker Change: Great. Thank you.

Ken: Are you seeing stabilization in the number of cycles per patient for Daniels or now.

Speaker Change: How do you see these impacting Danielle sub growth do you think that the guideline.

David Nierengarten: Now, David, good question. As we looked at this, it was important to get in and establish the safety of the protein. So that doesn't change. So the CD38 cyanotic construct is the same regardless of what link or chelator combination we're using. So the entire purpose of both the 1001 and the 1201 is looking at the overall safety of the platform. And similar to the 1001 with GD2, you want to have as few variables as possible. So maintaining the naked DOTA on the lutetium gives you that safety information you need from the CD38 so that when the safety is established as part of the bridging study for the new chelator linker, that can then be translated back in as an amendment to start looking at that as you advance the product forward for treatment.

Speaker Change: We will have an impact on shifting the kidneys and choice versus competitor and also if you could repeat again when do you anticipate that the investigator initiated this trial. Please thank you.

Kevin: Kevin It's a good question Doug.

Kevin: The stabilization is.

Kevin: Relevance.

Kevin: But I think overall, we see the volumes the remained consistent.

Speaker Change: Hey, good care I'll turn it over to Doug you can you can address the MCC and guidelines as well as the.

Kevin: Each individual facility there are small changes in protocols, but in general we're seeing year over year growth in number of vials per patient in the U S. We see similar trends abroad.

Speaker Change: The timing on the ISS as far as the MCC and guidelines are concerned we see this as putting us on similar footing with our competition from a recommendation standpoint out of the decision making.

Kevin: 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 MTGE two drugs and making sure that Danielle to has its rightful place in that treatment paradigm. So.

Speaker Change: Process still exist at the clinician level again back to reiterating where our focus is around educating and.

Speaker Change: Providing information to clinicians, making decisions on a day in day out basis, but it really removes what was a headwind for some certain accounts not being included in the guidelines.

Kevin: While we will continue to support and educate on number and how each individual patient is treated from a number of vial standpoint, our real focus is making sure that the clinically relevant.

David Nierengarten: So again, it's about establishing the safety of the protein, about the speed of getting that information, and then making the change once you have that variable down that you're confident that there's no safety signals from the protein itself.

Kevin: Information is in the hands of the decision makers, specifically the clinicians they're treating these patients.

Speaker Change: And does provide a potential tailwind for the team in the market as a whole to reevaluate the placement of Daniels in the treatment paradigm.

Speaker Change: Great and just a follow up on your efforts with daniels's. So you.

Speaker Change: So while <unk> referenced earlier around moving into guidance, we do anticipate some more open doors for the team to have discussions clinically.

Speaker Change: Matt referenced a couple of times, the Investor investigator initiated trial.

Kemp Dolliver: And our next question comes from Kemp Dolliver with Brookline Capital Markets. Your line is now open. Great, thank you. Are you seeing stabilization in the number of cycles per patient for Danielza now? Jim, that's a good question. Doug? The stabilization is Relevant, but I think overall, we see the volumes remain consistent at each individual facility. There are small changes in protocols, but in general, we've seen year-over-year growth in number of vials per patient in the U.S. We see similar trends abroad. I think the biggest area of focus for us is less around number of vials per patient.

Speaker Change: Essentially.

Speaker Change: And the Cogs cognate work.

Speaker Change: And again kind of rounding into both the clinical and our financial message not related to the guidelines.

Speaker Change: Has that trial initiated in how many sites are involved in how many sites are you trying to get involved.

Speaker Change: General around true no daniels's so.

Speaker Change: So the.

Speaker Change: In summary, it most likely removes a headwind to provide some potential for some tailwind.

Speaker Change: Protocols and the setup of the study is in the hands of the investigator, we're just supporting them.

Speaker Change: Now that we are referenced in the guidelines from a timing on the call trial, we've been consistent with Q2, we're not changing that timeline.

Speaker Change: This particular this next study will have multiple call facilities involved and they are.

Speaker Change: And I would say luminary facilities amongst that group. So we are quite excited about how this study has evolved and develops.

Speaker Change: We are a matter more like days and weeks from the start of this so we're quite excited about the start of that.

Speaker Change: We do anticipate a very near term start so hopefully there will be market information available to the market in the very near future.

Speaker Change: So the investigators quite frankly.

Speaker Change: So a lot of positive momentum for Daniels and the markets with some accounts that really don't have or at least previously hadn't had significant experience with the product.

Speaker Change: About the sites and what level of involvement.

Speaker Change: Great. Thank you so much.

Speaker Change: I think the other thing is opening up that to multiple sites, we expect enrollment to take place and be completed majority of the completed and the remainder of 2025.

Tim: Thank you Tim.

Doug Gentilcore: It's more around penetrating large accounts that are utilizing a number of anti-GE2 drugs and making sure that Daniella has its rightful place in that treatment paradigm.

Speaker Change: And our next question will come from <unk> <unk> with man unless shot Kempen. Your line is open.

Speaker Change: Hello team and thanks for taking my question and congratulation with the properties as well.

Speaker Change: Thank you very much.

Doug Gentilcore: 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. Great.

Pierre: Thanks Pierre.

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

Speaker Change: And one question for me about Danielle and inclusion learning the MTBE and guidelines, but also regarding indeed, the new investigator led trial.

Alec Stranahan: Hey, guys. Thanks for taking our questions just a couple from us.

Speaker Change: Trial in collaboration with the Cox advocacy groups.

Alec Stranahan: First curious that the category to a designation was expected from your side.

Kemp Dolliver: And just to follow up on your efforts with Danielza, so you have referenced a couple of times the investigator-initiated trial, essentially, in the COG network. Has that trial initiated, and how many sites are involved, and how many sites are you trying to get involved? So, the protocols and the setup of the study is in the hands of the investigator. We're just supporting them. But this particular, this next study will have multiple COG facilities involved, and they are key, and I would say luminary facilities amongst that group. So, we're quite excited about how this study has evolved and developed.

Speaker Change: I was wondering if you could talk a little bit more.

Alec Stranahan: Maybe unpack that a bit and how this stacks up versus other approved options.

Speaker Change: How do you see these impacting Daniela sub growth.

Speaker Change: Do you think that the guideline.

Alec Stranahan: Yes, Alex it's a great question as we look at this.

Speaker Change: Have an impact on shifting the activation choice versus competitor and also if you could repeat again when do you anticipate to the investigator initiated trial. Please thank you.

Alec Stranahan: <unk> designation.

Alec Stranahan: For us I mean that is expected.

Alec Stranahan: When you look at it.

Alec Stranahan: It is the level of information. So these are rare diseases.

Alec Stranahan: Our ultra rare diseases with small patient populations and not the widespread data youll see with.

Doug: Thank you Karen I'll turn it over to Doug you can you can address the MCC and guidelines as well as the.

Alec Stranahan: Drugs that are in a much larger patient population. So let's way is expected in the same as.

Doug: Timing on the ISS as far as the MCC and guidelines are concerned we see this as putting us on similar footing with our competition from a recommendation standpoint out of the decision making.

Alec Stranahan: As the competitor.

Alec Stranahan: So with that it gives us reassurance that we're on the same playing field and also.

Chiara Monterani: We do anticipate a very near-term start, so hopefully there will be information available to the market in the very near future. about the sites and what level of them all. Great. Thank you so much.

Doug: Process still exists at the clinician level again back to reiterating where our focus is around educating and.

Alec Stranahan: It was a high level of confidence from the CCN panel as well so it puts us in a very good position and on a level playing field with the competition.

Doug: Providing information to clinicians, making decisions on a day in day out basis, but it really removes what was a headwind for some certain accounts not being included in the guidelines.

Alec Stranahan: Okay, great that makes sense and maybe just one one more sort of higher level.

Chiara Monterani: Thank you, Tim. And our next question will come from Chiara Monterani with Van La Schott Kempen. Your line is open. Hello, team. Thanks for taking my question. Congratulations with the progress as well.

Alec Stranahan: The comments on the new appointment.

Doug: It does provide a potential tailwind for the team in the market as a whole to reevaluate the placement of Daniels in the treatment paradigm.

Alec Stranahan: The ore seeber.

Alec Stranahan: Any changes in your regulatory interactions or development approach for any of your assets.

Chiara Monterani: So, one question for me about Danielza and the inclusion in the MTCN guidelines, but also regarding indeed the new investigator-led trial in collaboration with the Cox Advocacy Group. I was wondering if you could talk a little bit more How do you see this impacting Danielle's sub-roles? 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 that the investigator will initiate this trial, please? Thank you. Thank you, Kara.

Doug: So while <unk> referenced earlier around moving on to guidance, we do anticipate some more open doors for the team to have discussions clinically.

Alec Stranahan: Okay.

Alec Stranahan: I'll reserve comment on individuals' or departments or policy.

Alec Stranahan: But what we find is we have very close working relationships with the FDA and we're able to get our meeting schedules.

Doug: And again kind of rounding into both the clinical and the financial message not related to the guideline general around three mode Daniels us so.

Alec Stranahan: Get our documents reviewed so.

In summary, it most likely removes a headwind to provide some potential for some tailwind now.

Alec Stranahan: I think the entire countries in a wait and see on any changes and new administrations. However, we continue to move forward and Theres a lot of great people and the FCA that we've been working with for a long period of time and we continue to have good Alex.

Doug: Now that we are referenced in the guidelines from a timing on the call trial.

Doug: Ben consistent with Q2, we're not changing that timeline.

Speaker Change: Chip, so always a positive outlook on.

Doug: We think we're a matter more like days and weeks from the start of this so we're quite excited about.

Speaker Change: People doing good work and the FDA and are responding accordingly, and wanting to see patients get treated so we feel very good about where we are today and hopefully that continues in the future.

Doug: The start of that.

Doug Gentilcore: I'll turn it over to Doug. He can address the NCCN guidelines as well as the timing on the ISS. As far as the MCCN guidelines are concerned, we see this as putting us on similar footing with our competition from a recommendation standpoint. Now, the decision-making process still exists at the clinician level. Again, back to reiterating where our focus is, is around educating and providing information to the clinicians, making decisions on a day-in, day-out basis. But it really removes what was a headwind for some, in a certain account, not being included in the guideline, and does provide a potential tailwind for the team and the market as a whole to re-evaluate the placement of Danielle's in the treatment paradigm.

Doug: So the investigators quite frankly.

Doug: So a lot of positive momentum for Daniels and the markets with some accounts that really don't have or at least previously hadn't had significant experience with the product.

Speaker Change: I appreciate the color and thanks for the questions.

Speaker Change: Yes.

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

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

Mike Rossi: Great. Thank you everyone for joining us today and discussing our first quarter 2025 results and our continued progress. We believe wimax is well positioned to execute and achieve strategic priorities across our Daniels and radiopharmaceutical business units in 2025 and beyond we look forward to a radiopharmaceutical pipeline update in our <unk>.

Speaker Change: Thank you very much.

Pierre: Thanks Pierre.

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

Speaker Change: Hey, guys. Thanks for taking our questions just a couple from us.

Mike Rossi: The phase one part a data readout in May 28.

Mike Rossi: Hard to seeing everybody, there and have a great day.

Speaker Change: First <unk>.

Speaker Change: Curious if the category to a designation was expected from your side.

Mike Rossi: This concludes today's conference call. Thank you for participating you may now disconnect.

Doug Gentilcore: So, while, as Peter referenced earlier, we're not moving any guidance, we do anticipate some more open doors for the team to have discussions clinically. And again, kind of rounding into both the clinical and the financial message not related to the guidelines, but just general around treatment with Daniella. So, in summary, it most likely removes a headwind and provides a potential for some tailwinds now that we are referencing the guidelines. From a timing on the call trial, we've been consistent with Q2. We're not changing that timeline. We think we're a matter more like days than weeks from the start of this, so we're quite excited about the start of that, and so are the investigators, quite frankly.

Speaker Change: Maybe unpack that a bit and how this stacks up versus other approved options.

Alex: Yes, Alex.

Speaker Change: Question as we look at this.

Speaker Change: <unk> designation for Us I mean that is expected.

Speaker Change: When you look at it that.

Speaker Change: It is the level of information. So these are rare diseases.

Speaker Change: Our ultra rare diseases with small patient populations and not the widespread data you see with.

Speaker Change: Drugs that are in a much larger patient population. So let's way is expected in the same as.

Speaker Change: As the competitor.

Speaker Change: So with that it gives us reassurance that we're on the same playing field and also.

Speaker Change: It was at the high level of confidence from the CCN panel as well so it puts us in a very good position and on a level playing field with the competition.

Alec Stranahan: So, a lot of positive momentum for Daniella in the market with some accounts that really don't have, or at least previously hadn't had significant experience with the product. I think the other thing is opening up that to multiple sites, we expect enrollment to take place and be completed, the majority of it completed in the remainder of 2025. Thank you very much. Thank you.

Speaker Change: Okay, great that makes sense and maybe just one one more sort of higher level.

Speaker Change: Any comments on the new appointment.

Speaker Change: Var or seeber.

Speaker Change: Any changes in your regulatory interactions or development approach for any of your assets.

Alec Stranahan: And our next question comes from Alec Stranahan with Bank of America. Your line is open. Hey, guys. Thanks for taking our questions. This is just a couple from us. First, I'm curious if the Category 2A designation was expected from your side. Maybe unpack this a bit and how this, you know, stacks up versus other approved options. Yeah, Alex, it's a great question. As we look at this, the 2A designation, for us, I mean, that is expected. And when you look at it, it is the level of information. So these are rare diseases, or ultra rare diseases with small patient populations and not the widespread data you see with drugs that are in a much larger patient population.

Speaker Change: Okay.

Speaker Change: I'll reserve comment on individuals.

Speaker Change: Departments or policy.

Speaker Change: But what we find is we have very close working relationships with the FDA and we're able to get our meeting schedules.

Speaker Change: Get our documents reviewed so.

Speaker Change: I think the entire countries in a wait and see on any changes and new administrations. However, we continue to move forward and there is a lot of great people and the FCA that we've been working with for a long period of time and we continue to have good relationships. So always a positive outlook on on people doing good work and the FDA and are responding accordingly.

Speaker Change: Wanting to see patients get treated so we feel very good about where we are today and hopefully that continues in the future.

Speaker Change: I appreciate the color and thanks for the questions.

Alec Stranahan: So the 2A is expected and the same as as the competitor. So with that, it gives us reassurance that we're on 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 on a level playing field with competition. Okay, great. That makes sense.

Speaker Change: Yes.

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

Mike Rossi: Great. Thank you everyone for joining us today and discussing our first quarter 2025 results and our continued progress. We believe wimax is well positioned to execute achieve strategic priorities across our Daniels and radiopharmaceutical business units in 2025 and beyond we look forward to our radiopharmaceutical pipeline update in our <unk>.

Mike Rossi: And maybe just one, one more sort of higher level. Any comments on the new appointment? and FDA or CBER. Any changes in your regulatory interactions or development approach for any of your AFNPs? Thank you. You know, it's, I'll reserve comment on individuals or departments or policy, but what we find is we have very close working relationships with the FDA, and we're able to get our meetings scheduled, get our documents reviewed. So, you know, it's, I think the entire country's in a wait and see on any changes in new administrations. However, we continue to move forward, and there's a lot of great people in the FDA that we've been working with for a long period of time, and we continue to have good relationships.

Mike Rossi: The phase one part a data readout in May 28 look forward to seeing everybody there and have a great day.

Mike Rossi: This concludes today's conference call. Thank you for participating you may now disconnect.

Mike Rossi: [music].

Operator: So, always a positive outlook on people doing good work in the FDA and responding accordingly and wanting to see patients get treated. So, we feel very good about where we are today, and hopefully that continues to continue. Appreciate the color and thanks for the question. I show no further questions at this time.

Mike Rossi: I would now like to turn the call back to Mike Rossi for closing remarks. Great. Thank you, everyone, for joining us today and discussing our first quarter 2025 results and our continued progress.

Mike Rossi: We believe Y-mAbs is well-positioned to execute and achieve strategic priorities across our Danielzen radiopharmaceutical business units in 2025 and beyond.

Mike Rossi: We look forward to our radiopharmaceutical pipeline update and our GD2-SATA Phase 1 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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Mike Rossi: [music].

Q1 2025 Y-mAbs Therapeutics Inc Earnings Call

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