Q1 2024 Y-mAbs Therapeutics Inc Earnings Call

Speaker Change: [music].

Operator: Good morning and welcome to Y-mAbs Therapeutics, Inc.'s earnings conference call for the first quarter of 2020. At this time, all participants are in a listen-only mode. Instructions for the question and answer session will follow the prepared remarks. As a reminder, today's conference will be recorded. I will now hand the call over to Y-mAbs Head of Investor Relations, Courtney Dugan.

Good morning, and welcome to the White maps Therapeutics, Inc. Earnings Conference call for the first quarter of 2024 at this time all participants are in a listen only mode instruction for the question and answer session will follow the prepared remarks as a reminder, today's conference will be recorded.

I will now hand, it over to <unk> head of IR Courtney Dugan.

Courtney Dugan: Thank you, Operator, and good morning, everyone. Welcome to the YNAB First Quarter 2024 Financial Results Conference Call. We issued a press release yesterday at market close. The press release and accompanying slides are available in the Investor Relations section of our website.

Courtney Dugan: Thank you operator, and good morning, everyone and welcome to the wine as first quarter of 2024 financial results Conference call.

Speaker Change: Issued a press release this morning or yesterday excuse me at market close.

Courtney Dugan: Press release and accompanying slides are available on the IR section of our website.

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 and development, commercialization, and product distribution plans, expectations with respect to early trial data, current and future clinical and preclinical studies, and our research and development programs, expectations related to the timing of the initiation and completion of regulatory submissions, regulatory, marketing, and reimbursement approvals, including statements with respect to the future development of other development programs.

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.

Courtney Dugan: The statements include but are not limited to statements about our business model and development commercialization and product distribution plans.

Courtney Dugan: Spectators with respect to early trial data.

Courtney Dugan: Current and future clinical and preclinical studies, and our research and development programs.

Courtney Dugan: Expectations related to the timing of the initiation and completion of regulatory submissions.

Courtney Dugan: Regulatory marketing and reimbursement approvals, including statements with respect to future development or other development programs.

Courtney Dugan: <unk> for Daniels of territory and label expansion and potential of an advancement of thought of glass.

Courtney Dugan: Collaborations our strategic partnerships and the potential benefits thereof expectations related to our anticipated cash runway and cash burn and the sufficiency of our cash resources and assumptions related thereto.

Courtney Dugan: <unk> and expectations for 2024, and beyond and our financial performance, including our estimates regarding revenues expenses and capital expenditure requirements and other statements that are not historical facts.

Courtney Dugan: Because forward looking statements involve risks and uncertainties. They are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward looking statements due to a variety of factors, including those risk factors discussed in the company's quarterly report on Form 10-Q.

Courtney Dugan: <unk> for the quarter ended March 31, 2024 as filed with the SEC on a seventh 2024.

Courtney Dugan: Potential for Danielle's Territory and Label Expansion, and the Potential for and Advancement of SADA. Collaborations or Strategic Partnerships and the Potential Benefits Thereof. Expectations related to our Anticipated Cash Runway and Cash Burn, and the Sufficiency of our Cash Resources and Assumptions related thereto, guidance and expectations for 2024 and beyond, and our financial performance, including our estimates regarding revenues, expenses, and capital expenditure requirements, and other statements that are not historical facts. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.

Courtney Dugan: I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi.

Michael Rossi: Thank you Courtney.

Michael Rossi: Good morning, and thank you for joining us. I have with me today our Chief Financial Officer, Bo Kruse, our Chief Commercial Officer, Sue Smith, and our Chief Medical Officer, Dr. Vignesh Rajah. Thomas Gad, our founder and chief business officer, will join us for the Q&A portion of this call following our prepared remarks. This morning, I will start off by reviewing key financial and operational highlights from the first quarter of 2024, including Danielle's sales performance and the clinical progress of our radiotherapy clinical programs, utilizing our self-assembly, disassembly, pre-targeted radioimmune therapy, or SADA

Michael Rossi: Good morning, and thank you for joining us I have with me today are Chief Financial Officer Bo Kruse.

Michael Rossi: <unk> commercial officer, Sue Smith notes.

Michael Rossi: <unk> Medical officer Doctor domestically.

Michael Rossi: Thomas Gad, our founder and Chief business Officer will join us for the Q&A portion of this call following our prepared remarks.

Michael Rossi: Next, Sue will provide details around our Global Danes of Sales in the first quarter. Vignesh will then provide updates on our ongoing Nexidimab ISS clinical trial. I will then provide an overview of our first quarter of 2024 financial performance, our cash resources, and reiterate our full 2024 guidance before we open the line for Q&A. Let's begin with key highlights for the first quarter of 2024, starting with Danielle. As a reminder, Danielle's is approved by the US FDA for the treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow for patients who have demonstrated a partial response, minor response, or stable disease with prior therapy. Neuroblastoma is the most common cancer in infants and the third most common cancer in children.

Michael Rossi: This morning, I will start off by reviewing key financial and operational highlights from the first quarter of 2024, including Daniels's sales performance and the clinical progress of our radiotherapy clinical programs utilizing our self assembly disassembly pre targeted radio therapy or sort of print technology platform.

Michael Rossi: Next she will provide details around our global daniels's sales in the first quarter.

Nash: The Nash will then provide updates around our ongoing next to them at a I S. That's clinical trials.

Nash: He will then provide an overview of our first quarter of 2024 financial performance, our cash resources and reiterate our full 2024 guidance before we open the line for Q&A.

Michael Rossi: In the first quarter of 2024, we achieved record U.S. net sales, product sales of Danialza of $18.6 million, up 11% from what we recorded in the first quarter of 2023. We achieved record demand for Danielsa by further penetrating the top high-volume centers across the U.S. We expect this positive momentum to continue throughout the year. From a worldwide standpoint, we achieved global Danielle net product sales of $19.4 million in the first quarter of this year, a 4% decrease from the same period in 2023.

Nash: To begin with key highlights from the first quarter of 2024, starting with Danielle.

Nash: As a reminder, daniels's approved.

Nash: By the U S FDA for the treatment of relapsed or refractory high risk neuroblastoma in bone or bone marrow for patients who have demonstrated a partial response minor response or stable disease with prior therapies.

Nash: Europe Blastoma is the most common cancer in infants and the third most common cancer in children.

Nash: In the first quarter of 2024, we achieved record U S. Net sales product sales of Daniels of $18 6 million up 11% from what we recorded in the first quarter of 2023.

Nash: We achieved record demand vials sold I'm Danielle so.

Nash: Further penetrating the top high volume centers across the U S. We expect this positive momentum to continue throughout the year.

Nash: From a worldwide standpoint, we achieved global Daniels and net product sales of $19 $4 million.

Nash: First quarter of this year, a 4% decrease from the same period in 2023.

Michael Rossi: While the decrease was primarily driven by lower product purchases from international markets in the first quarter of 2024, compared to the prior year, as expected, first quarter total net product revenue came in ahead of our internal projections. We remain confident in our full year 2024 revenue guidance as we continue to grow momentum in the U.S. and with our partners in ex-U.S. markets. We have 63 sites activated across the U.S. to date, with five new accounts added in the first quarter of this year. Our U.S. commercial team has been doing a fantastic job of continuing to penetrate high-volume centers, increasing physician adoption of Damien. In addition to the U.S., our ex-U.S. footprint continues to expand through multiple partnerships.

Nash: While the decrease was primarily driven by lower product purchases from international markets in the first quarter of 2024 compared to the prior year as expected.

Nash: First quarter total net product revenue came in ahead of our internal projections.

Nash: We remain confident in our full year 2020 for revenue guidance as we continue to grow momentum in the U S and with our partners in ex U S markets.

Nash: We have 63 sites activated across the U S to date with five new accounts added in the first quarter of this year.

Nash: Our U S. Commercial team has been doing a fantastic job of continuing to penetrate high volume centers.

Nash: Increasing physician adoption of Daniela.

Nash: In addition to the U S or ex U S footprint continues to expand through multiple partnerships.

Michael Rossi: Danielle's is approved and has been launched in China through our partner Cyclone and has recently been launched by our partner ADM in Brazil and Mexico just a few weeks ago. We look forward to providing further updates on these launches in the coming quarter. Our European Named Patient Program with Web Clinical is continuing to progress as we support the needs of children with high-risk relapsed or refractory neuroblastoma. In addition, we plan to submit a BLA for Danielza in Argentina this year and could potentially receive an additional approval in Asia in Hong Kong next year.

Nash: Daniels's approved it has been launched in China through our partner cyclone.

Nash: It has been recently launched by our partner in Brazil, and Mexico, just a few weeks ago we.

Nash: We look forward to providing further updates on these launches in the coming quarters.

Nash: Our European named patient program with web clinical.

Nash: Is continuing to progress as we support the needs of children with high risk relapsed or refractory neuroblastoma in Europe.

Nash: In addition, we plan to submit a BLA for Daniels in Argentina, this year and could potentially receive an additional approval in Asia in Hong Kong next year.

Michael Rossi: We continue to see progress among our ongoing ISS and Exitimab trials in support of our Indication Expansion Strategy. In particular, we look forward to Memorial Sloan-Kettering's readout from its multicenter Phase 2 trial investigating nexidermab in patients with relapsed osteosarcoma, as we anticipate in the fourth quarter of this year. You will hear more about the progress of the ongoing investigator-sponsored trials of Nexidimab from Vignesh later during this call. Now, let me shift to the clinical progress of our SATA PREP program.

Nash: We continue to see progress among our ongoing I guess that makes it a mab trials in support of our indication expansion strategy.

Nash: In particular, we look forward to memorial Sloan Kettering readout from its multicenter phase II trial investigating <unk> in patients with relapsed relapsed osteosarcoma as we anticipate in the fourth quarter of this year.

Nash: You will hear more about the progress of the ongoing investigator sponsored trials of next set of map from domestic later during this call.

Nash: Now, let me shift to the clinical progress of our <unk> programs.

Michael Rossi: Phase 1, GD2 SADA. Our first SADA clinical program is our GD2 SADA, which is in phase one, evaluating its safety and tolerability. And that is in the treatment of GD2-positive solid tumors, including small cell lung cancer, sarcomas, and malignant melanoma. This Phase I Dose Escalation Single-Arm Multi-Center Safety Study has three parts, which you can see here. Part A explores dose finding for a GD2 SADA molecule and the testing of dose intervals of two to five days between the protein and the lutetium dota payload.

Nash: Phase one G D to sort out.

Nash: Our first thought clinical program is our GDT Sada, which is in phase one evaluating safety and Tolerability.

Nash: And that is in the treatment of <unk> positive solid tumors, including small cell lung cancer, Sarcomas and malignant melanoma.

Nash: This phase one dose escalation single arm Multicenter safety study has three parts, which you can see here.

Michael Rossi: Part B determines the optimal dose of lutetium dota, and Part C evaluates the safety and initial signs of efficacy using repeat dosing. We are currently in Part A and are very pleased with how the trial has progressed. We have advanced through cohorts one, two, and three and are now dosing patients in cohort four. We have dosed a total of 14 patients to date in this trial. We currently have seven sites open and plan to continue adding additional sites. Recall that Part A is the trial investigating the safety profile of the protein and determining the optimal timing to administer the radionuclide.

Nash: Part a explores dose finding for Judy to Saddam molecule and the testing of dose intervals of two to five days between the proteins and the lutetium Dota payload.

Nash: Part be determined the optimal dose of lutetium Dota part C evaluates the safety and the initial signs of efficacy using repeat dosing.

Michael Rossi: The evaluation is still ongoing, but we remain very encouraged by what we've seen so far.

Nash: We are currently in part a and are very pleased with how the trial is progressing we have advanced our cohorts one two and three are now dosing.

Nash: And cohort four.

Nash: We've dosed a total of 14 patients to date in this trial.

We currently have seven sites open and plan to continue adding additional sites.

Nash: Recall that part a of the trial investigating the safety profile of the protein and determining the optimal timing to administer the radionuclide evaluation is still ongoing.

Nash: We remain very encouraged by what we've seen so.

Nash: So far.

Michael Rossi: To date, no patients in the trial have experienced any dose-limiting toxicities, and there have been no instances of treatment-related serious adverse events. Based on the SPECT-CT scans and PK activity we have seen to date, we believe we have demonstrated proof of concept that GD2-SATA can both find and bind to tumors. It is important to note that this early data is not complete, and it is not necessarily indicative of the full results or the ultimate success of the trials or the SADA development program.

Nash: To date no patients in the trial have experienced any dose limiting toxicities and there have been no instances of treatment related serious adverse events.

Nash: Based on the spec C T scans and PK activity, we've seen to date. We believe we have demonstrated proof of concept that Judy to sada can both find and buy into tumors.

Nash: It is important to note that these early data does not complete and.

Nash: And are not necessarily indicative of the full results or the ultimate success of the trials or the cider development program.

Michael Rossi: We expect to complete cohort five of Part A component of the Phase 1 study by the end of this year and look forward to present the full data set from Part A at a medical meeting in late 24 or 2025. Our second SATA PRIP program is the CD38 SATA, which we plan to first study in the treatment of Nott-Hodgkin's lymphoma, focusing on B and T-cell lymphoma. This will be our first SADA program in circulation. Our plan phase one follows a comparable design to our GD2 Sata phase one trial, which you can see here.

Nash: We expect to complete cohort five a part a component of phase one study by the end of this year and look forward to present, the full data set from part a at a medical meeting in late 'twenty four or 2025.

Nash: Our second thought of prep program as a CD 38, Sada, which we plan to first study in the treatment of non Hodgkin's lymphoma focusing on.

Nash: B and T cell lymphoma.

Nash: This will be our first startup program in circulating tumors.

Nash: Our planned phase one follows a comparable designed toward gd to sort of phase one trial, which you can see here.

Michael Rossi: We're on track to activate the first two sites in the second quarter of this year and expect recruitment of patients to follow the closing of the contract. We are incredibly excited by the opportunity of our SADA PrEP platform to potentially shift the treatment paradigm across a variety of cancers and potentially even indications beyond oncology. We look forward to providing further updates on our SADA PRIP programs and clinical progress throughout the year, including at the ASCO Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging or SNMMI Annual Meeting.

Nash: We're on track to activate the first two sites in the second quarter of this year and expect recruitment of patients to follow the closing of the contracts.

Nash: We are incredibly excited by the opportunity of our sada print platform to potentially shift the treatment paradigm across the variety of cancers and potentially even indications beyond oncology.

Nash: We look forward to providing further updates on our side of prep programs and clinical progress throughout the year.

Nash: Including at the <unk> annual meetings and the society of nuclear Medicine.

Nash: And molecular imaging or <unk> annual meeting, which both occur in June.

Michael Rossi: Shifting gears a bit, I want to take a moment to acknowledge Bo Kruse. As you likely saw in March, we announced Bo's resignation as CFO of Y-mAbs. Boas served as a CFO for nearly 10 years, and he has been a valuable member of our leadership team throughout his tenure.

Speaker Change: Shifting gears a bit I wanted to take a moment to acknowledge brokers as you likely saw in March we announced Bose resignation as CFO Wai maps bolus served as the CFO for nearly 10 years and there's been a valued member of our leadership team throughout his tenure.

Michael Rossi: He has ensured that Y-mAbs is in a strong financial and operational position as he soon transitions out of the role and supports us in the search for a new CFO. I want to thank Bo for his dedication to Y-mAbs and his strategic partnership. We wish him all the best as he embarks on his next career journey. Additionally, in March of this year, we entered into a separation agreement with our chief scientific officer, Steenlitz. The separation agreement did not result in a material impact on our financial state.

Speaker Change: He is ensure that why mobs is in a strong financial and operational position as he assumed transitions out of the rule and supports us in search of a new CFO.

Speaker Change: I want to thank Paul for his dedication to Wimax and a strategic partnership we wish him all the best as he embarks on his next career journey.

Speaker Change: Additionally in March of this year, we entered into a separation agreement with our Chief Scientific Officer, Steve Lisbon.

Speaker Change: The separation agreement did not result in material impact to our financial statements. We wish Doctor, let's be good luck with future endeavors, our search for a new Chief Scientific officer is ongoing with a focus on the continued advancement of our novel Radiopharmaceutical platform.

Michael Rossi: We wish Dr. Lisby good luck with future endeavors. Our search for a new chief scientific officer is ongoing, with a focus on the continued advancement of our novel radiopharmaceutical platform. I'm incredibly confident in our entire team, as we currently have in place here at WMet, and I'm really proud of the commitment to patience that each and every one of our team members demonstrates every day. We remain focused on our mission to improve patient lives and execute on our strategy to advance novel therapies through clinical development. I will now pass the call over to Sue Smith to provide further color on Global Daniel's sales for the first quarter of 2024. Thank you, Mike, and good morning.

Speaker Change: I'm incredibly confident and I and our entire team as we currently have in place here at why maps and I'm really proud of the commitment to patients that each and every one of our team members demonstrates every day.

Speaker Change: We remain focused on our mission to improve patient lives and execute on our strategy to advance novel therapies through clinical development.

Speaker Change: I will now pass the call over to Sue Smith to provide further color on global Daniels's sales for the first quarter of 2024.

Susan Smith: Thank you, Mike, and good morning, everyone. I'm really pleased with the commercial progress of Danielza on a global scale so far this year. Building on momentum from last quarter, we continued to see the fruits of our enhanced marketing efforts during the first quarter. Let me begin with our commercial progress in the U.S. During the fourth quarter of last year, we rolled out a new Danielza campaign in the U.S. aimed to reposition and elaborate on Danielza's differentiating characteristics in the treatment of high-risk neuroblastoma for patients who have experienced an incomplete response to induction therapy in their bone and bone marrow.

Susan Smith: Thank you, Mike and good morning, everyone I'm really pleased with the commercial progress of Daniels on global scale. So far this year.

Susan Smith: Building on momentum from last quarter, we continued to see the fruits from our enhanced marketing efforts during the first quarter.

Susan Smith: Let me begin with our commercial progress in the U S.

Susan Smith: The fourth quarter of last year, we rolled out a new Daniela campaign in the U S and to reposition and elaborate on Daniels is differentiating characteristics in the treatment of high risk neuroblastoma for patients who have experienced incomplete response to induction therapy and their bone and done marrow.

Susan Smith: This new campaign allows us to share our data for refractory versus relapsed patients separately and provide more detailed data regarding Danielsa's performance in two different patient populations, those patients with an incomplete response to induction therapy and patients who have relapsed after a prior therapy. The new campaign also demonstrates Danielza responses in children re-challenged with Danielza after prior GD2 therapy.

Susan Smith: This new campaign allows us to share data for factory versus relapsed patients separately and provide more detailed data regarding daniels's performance in two different patient populations those patients with an incomplete response.

Susan Smith: Response to induction therapy and patients who are relapsed after prior therapy.

Susan Smith: The new campaign also demonstrates Daniels, our responses and children re challenged with Daniels after prior JD to therapy.

Susan Smith: We continue to expect to see meaningful traction from the new campaign over the coming quarters. In our first quarter, 2024, U.S. Daniels and Net Product Revenues increased 11 percent year-over-year to $18.6 million. The U.S. accounts for more than 80% of Danielle's sales.

Susan Smith: We continue to expect to see meaningful traction from the new campaign over the coming quarters.

Susan Smith: Our first quarter 2024 U S. Daniels of net product revenues increased 11% year over year to $18 6 million.

Susan Smith: The U S accounts for more than 80% of Daniels's sales first.

Susan Smith: And the first quarter of 2024 marked a record high in terms of U.S. Danielsa demand and vials sold. In the U.S., we achieved sales well above the first quarter portion of our internal forecast with the highest ever number of vials sold in a quarter since the initial launch back in 2011, 2021. In the first quarter of 2024, U.S. sales measured in vials were 9% higher than the fourth quarter of 2023, and March 2024 was the highest month of vial sales in the U.S. ever. Bo will provide further color later during the call.

Susan Smith: First quarter of 2024 marked a record high in terms of U S Danielson demand and vials sold.

Susan Smith: In the U S. We achieved sales well above the first quarter a portion of our internal forecast with the highest ever number of vials sold in a quarter since initial launch launch back in 2011 2021, sorry.

Susan Smith: In the first quarter of 2024 U S sales measured in vials were 9% higher than the fourth quarter of 2023.

Susan Smith: And March 2024 was the highest month of IOL sales in the U S ever.

Speaker Change: We'll provide further color later during the call.

Susan Smith: Further, the team is focused on multiple U.S. key activities driving performance in the first quarter and beyond. In the first quarter of 2024, the marketing team launched an accompanying enhanced digital campaign. The field sales team is hard at work educating customers on the new data, contributing to Daniels' continued growth outside of MSK, with 16 percent growth in the first quarter of this year versus the fourth quarter of 2023. The commercial team also engaged with key customers with an active presence at meetings such as ASFO, AFON, and the tandem transplant meeting during the first quarter.

Speaker Change: Further the team is focused on multiple U S key activities driving performance in the first quarter and beyond.

Speaker Change: First quarter of 2020 for the marketing team launched an accompanying enhanced digital campaign.

Speaker Change: Field sales team is hard at work educating customers on the new data.

Speaker Change: <unk> to Daniel's us continued growth outside of M. S K with 16% growth in the first quarter of this year versus fourth quarter of 2023.

Speaker Change: The commercial team also engaged with our key customers with active presence at meetings, such as ASO Avon in tandem transplant meeting during the first quarter.

Susan Smith: A total of 63 accounts have now used Danielza around the U.S. since its initial launch in 2021, with five new accounts added in the first quarter of 2024. February 2024 marked the highest number of active sites, in My computer just stopped. The highest number of active sites in a single month since its initial launch. My apologies.

Speaker Change: A total of 63 accounts have now use daniels around the U S. Since its initial launch in 2021 with five new accounts added in the first quarter of 2024.

February 2024 marks the highest number of active sites.

Speaker Change: In.

Speaker Change: I'm sorry.

Speaker Change:

Speaker Change: My computer just stopped.

Speaker Change: The highest number of active sites in a single month since initial launch my apologies.

Speaker Change: Continue to increase share of sales outside of M. S. K and now count 60% of X M. S K sales compared to 55% of sales.

Susan Smith: We continue to increase our share of sales outside of MSK and now count 60% of ex-MSK sales compared to 55% of sales, XMSK, in the fourth quarter of 2023. In fact, our XMSK sales were the best ever in the month of March 2024. Physician utilization of Danielza also continues to grow. 18 healthcare practitioners started a patient on Danielza in the first quarter of 2024. Since launch, a total of 106 HCPs have prescribed Danielza, and 31 HCPs have started treatment on two or more patients as of March 31st, 2024.

Speaker Change: <unk> came in the fourth quarter of 2023.

Speaker Change: In fact, our axon Ms. Kay sales were the best ever in the month of March 2024.

Speaker Change: Physician utilization of Daniels are also continues to grow.

Speaker Change: <unk> health care practitioners started a patient on Daniels that in the first quarter of 2024.

Speaker Change: Since the launch a total of 106 Hcp's have prescribed Daniels and 31 Hcp's has started treatment on two or more patients as of March 31 2024.

Susan Smith: Our U.S. commercial sales team continues to receive positive HCP feedback on Danielza through ongoing customer interaction. In addition, we continue to see institutional adoption of Danielza, which was added to three hospital formularies in the first quarter of 2024, bringing the total since launch to 44 hospital formularies as of March 31st, 2024. We continue to see an upward trend of sales growth in the U.S. since initial launch, as Danielza positively impacts patient lives in a highly important area of pediatric neuroblastoma, and it remains a leading therapy in the U.S. anti-GD2 market.

Speaker Change: Our U S. Commercial sales team continues to receive positive HCP feedback on daniels's through ongoing customer interactions.

Speaker Change: In addition, we continue to see institutional adoption of Daniel's, though which was added to three hospital formularies in the first quarter of 2024, bringing the total since launch $2 44 Hospital formularies as of March 31 2024.

Speaker Change: We continue to see an upward trend of sales growth in the U S folks on the phone launch of Dan you also positively impact patient lives and are highly important area of pediatric neuroblastoma.

Speaker Change: And it remains a leading therapy in the U S. Anti G D to market. We believe we have room for continued growth.

Susan Smith: We believe we have room for continued growth. Now, let's turn to our global commercial progress. Our first quarter of 2024 total Daniels and net product revenues decreased 4% to 19.4 million versus the first quarter of 2023, primarily driven by timing in international purchases.

Speaker Change: Now, let's turn to our global commercial progress.

Speaker Change: Our first quarter of 2024 total Daniels of net product revenues decreased 4% to $19 4 million versus the first quarter of 2023.

Speaker Change: Primarily driven by timing and international purchases.

Susan Smith: Despite this 4% decrease, total product revenues came in above our internal forecast. This positive start sets a promising tone for upcoming quarters, as our team remains steadfastly focused on further market penetration to bring Danielza to more pediatric high-risk neuroblastoma patients. We continue to receive positive feedback on physician uptake of Danielza in China through our partner, Cyclone. During the first quarter of this year, our South American partner, ADM, came to an agreement with the Drug Market Regulation Chamber, or CMED, on the price of Danielle's in Brazil and launched it in both Brazil and Mexico just a few weeks ago.

Speaker Change: Despite this 4% decrease total product revenues came in above our internal forecast. This positive start that's a promising tone for upcoming quarters as our team.

Speaker Change: We remain steadfastly focused on further market penetration to bring Dan houser to more pediatric high risk neuroblastoma patients.

Speaker Change: We continue to receive positive feedback and physician uptake of Daniel's in China through our partner cyclone during the first quarter of this year, our South American partner ADM came to an agreement with the drug market regulation chamber or seen that on the price of Daniel's in Brazil, and launched in both Brazil, and Mexico, just a few.

Speaker Change: Weeks ago.

Susan Smith: We look forward to updating you on our continued global commercial progress in the coming quarters, and we remain confident in reaching our total Danielsa net product sales guidance for the full year of 2024 of between $95 million and $100 million. Let me now pass the call to Vignesh.

Speaker Change: We look forward to updating you on our continued global commercial progress in the coming quarters, and we remain confident in reaching our total Daniels and net product sales guidance for the full year of 2024 of between $95 million and $100 million.

Speaker Change: Let me now pass the call to the Nash.

Vignesh Rajah: Thank you, Sue. Hello, everyone.

Nash: Thank you Sue Hello, everyone I'm pleased to provide a brief update on our ongoing <unk> clinical.

Vignesh Rajah: I'm pleased to provide a brief update on our ongoing Nexidermab clinical trials. We continue to advance potential label expansion opportunities for Danielle Zhou through our investigative-sponsored clinical studies in collaboration with leading care wells in frontline high-risk neuroblastoma. Our partner, the Beat Childhood Cancer Research Consortium, or BCC, is conducting a multi-center phase two trial evaluating necidomab in combination with standard induction therapy for patients with newly diagnosed high-rest neuroblastoma. Sixteen sites have been opened, and recruitment is ongoing.

Nash: Clinical trials.

Nash: We continue to advance potential label expansion opportunities for Danielle <unk> investigator sponsored clinical studies in collaboration with leading Kols.

Nash: And the frontline high risk neuroblastoma, presenting a partner to be childhood cancer research consortium or BCC is conducting a multi center phase II trial evaluating <unk> in combination with standard induction therapy for patients with newly diagnosed high risk neuroblastoma.

Nash: 16 sites have been open and recruitment is ongoing the trial is expected to transition from a single arm study with makes good amount added to the current standard of treatment for reduction to a randomized strong where the control arm will be the standard of care for induction therapy, which is chemotherapy for which.

Vignesh Rajah: The trial is expected to transition from a single-arm study with acidamab added to the current standard of treatment for induction to a randomized trial where the control arm will be the standard of care for induction therapy, which is chemotherapy, for which we will plant a phylin I and D. Our aim for the randomized trials is to demonstrate superiority in complete response at the end of induction therapy in an ex-sitemap arm versus standard The BCC expects to potentially initiate a new randomized study in the second quarter of this year.

Nash: We plan on an RMB.

Nash: Alright, and for the randomized trials to demonstrate superiority in complete response at the end of induction therapy, and then extra demand bump versus standard of care.

Nash: The BCC expect country initiate the new randomized study in the second quarter of this year.

Vignesh Rajah: In osteosarcoma, we are working with Memorial Sloan Kettering Cancer Center on its multi-center investigator-sponsored trial for oxidomab. We continue to expect MSK to provide data readout from this Phase I-II trial in the fourth quarter of this year, and based on the outcome of this, we will evaluate plans for our pivotal randomized trial anticipated to be initiated in the second quarter of 2025. In breast cancer, we are partnering with Ohio State University on a Phase 1B2 trial investigating TGF beta NK cells, gem cider bean, plus axidomab in patients with GD2 positive metastatic breast cancer.

Nash: And also to sarcoma, we are working with Memorial Sloan Kettering Cancer Center on its multi center investigator sponsor trial for an extra demand.

Nash: We continue to expect MSA to provide a data readout from the phase one two trial in the fourth quarter of this year and based on the outcome of this we will evaluate trends for our pivotal randomized trial.

Nash: Space to BD shades in the second quarter of 2025.

Nash: In breast cancer, we are partnering with the Ohio State University on a phase <unk> trial investigating <unk> TGF beta NK cells Gemcitabine plus next good amount in patients with <unk> positive metastatic breast cancer.

Vignesh Rajah: The first patient is expected to be dosed with Danielle's in the second quarter of this year. Upon the outcome of this trial, we will consider moving forward with a multicenter phase 2 trial. In addition, we have partnered with the Institute of Mother and Child in Poland on a randomized phase 2 trial evaluating the efficacy and safety of Nexidermab in patients with refractory Ewing sarcoma, which will be initiated in the fourth quarter of 2023.

Nash: Transportation is expected to be dosed with Daniels and the second quarter of this year.

Nash: But from the outcome of this trial, we will consider moving forward with a multi center phase II trial.

Nash: In addition, we have partnered with the Institute of mother and child in Poland on a randomized phase II trial evaluating the efficacy and safety of <unk> in patients with refractory Ewing sarcoma, which is initiated during the fourth quarter of 2023.

Vignesh Rajah: Recruitment is ongoing, and three patients have been dosed in the Nexidermab arm to date. We expect a total of 16 patients in that arm. The trial is expected to be completed in 2028. However, a significant treatment gap remains in the anti-GD2 space in both pediatric and adult cancers. We are committed to supporting the advancement of these investigative sponsored studies through clinical development and working to unlock the full potential value of Nexidima. We look forward to updating you on our progress at Ascolated this month and in the coming quarters. Let me now hand the call over to Bo Kruse.

Nash: Recruitment is ongoing and three patients have been dosed in the next day.

Nash: To date, we expect a total of 16 patients in that.

Nash: The trial is expected to be completed in 2028.

Nash: The significant treatment gap remains in the antibody space in both pediatric and adult cancers. We are committed to supporting the advancement of these investigator sponsored studies through clinical development and working to unlock the full potential value of mix it Matt.

Nash: We look forward to updating you on our progress and escalate to this month and in the coming quarters.

Nash: Let me now hand, the call over to Bo Kruse.

Bo Kruse: Thank you, Vignesh, and good morning. As you heard from Mike and Sue, U.S. revenues increased 11% to 18.6 million in the first quarter compared to 16.8 million in the same quarter of 2023, while international revenues decreased by 2.6 million. 2.8 million in the first quarter compared to 3.4 million in the first quarter of 2023. The decline in international revenues was driven by our distribution partner WebClinicum, which generated revenues in the first quarter of 2023 of 2.5 million due to an initial inventory stocking order, compared to no revenues in the first quarter of 2024.

Bo Kruse: Thank you have a weakness and good morning, everyone.

Yeah.

Bo Kruse: As you heard from Mike and Sue U S revenues increased 11%.

Bo Kruse: $18 6 million in the first quarter compared to $16 8 million in the same quarter of 2023, while international revenues decreased by $2 6 million too.

Bo Kruse: $2 8 million in the first quarter compared to 3.4.

Bo Kruse: $4 million in the first quarter of 2023.

Bo Kruse: The decline in international revenues was driven by our distribution partner with clinical which generated revenues in the first quarter of 2023 of $2 5 million due to an initial inventory stocking order.

Bo Kruse: Compared to no revenues in the first quarter of 2024.

Bo Kruse: Our global Danielsa net product revenues of $19.4 million in the first quarter 2023 represented a 4% decrease compared to the same quarter of 2023. U.S. Danelta net product revenues increased 3% compared to the quarter ended December 31, 2023, when excluding the $0.3 million and $1.3 million impact from Medicaid accrual change in estimate recognized as increases in net product revenues in the quarters ended March 31, 2024, and December 31, The Danielsa Net Product Revenues of $19.4 million in the first quarter of 2024 represented a 17% decrease compared to the fourth quarter of 2023 and was primarily driven by decreased international revenue. We report it.

Bo Kruse: Our global Daniels of net product revenues of $19 4 million in the first quarter 2023 represented a 4% decrease compared to the same quarter of 2023.

Bo Kruse: U S net product revenues increased 3% compared to the quarter ended December 31st 2023, when excluding the <unk> 3 million and $1 $3 million impact from Medicaid pool changed an estimate recognized as increases in net product revenue.

Bo Kruse: <unk> in the quarters ended March 31st 2024, and December 31 2023, respectively.

Bo Kruse: The Nielsen net product revenues of $19 4 million in the first quarter of 'twenty 'twenty four represented a 17% decrease compared to the fourth quarter of 2023 and was primarily driven by decreased international revenues.

Bo Kruse: We reported.

Bo Kruse: $500,000 worth of licensed revenues in the three months ended March 31, 2024 and did not have any licensed revenue for the three months ended March 31, 2023. Moving to operating expenses, our research and development expenses decreased slightly by 0.1 million to 13.3 million for the three months ended March 31st, 2024, compared to the same period in 2023. The decrease was primarily due to a decrease in personnel costs related to our restructuring charge recorded in the quarter ended March 31st, 2023, partially offset by a $2.5 million increase in clinical trial costs due to our investments in our cyber programs in 2024.

Bo Kruse: $500000 worth of license revenues.

Bo Kruse: The three months ended March 31, 2020, full and did not have license revenue for the three months ended March 31 2023.

Bo Kruse: Moving to operating expenses research and development expenses decreased slightly by <unk> 1 million to $13 3 million for the three months ended March 31st 2020 full pants.

Bo Kruse: Pads with the same period in 2020 free.

The decrease was primarily due to a decrease in personnel costs related to our restructuring charges recorded in the quarter ended March 31st 2020, free partially offset by $2 $5 million increase in clinical trial costs due to our investments in outside of the <unk> programs in 2024.

Bo Kruse: Selling, general, and administrative expenses decreased by 0.8 million to 11.4 million for the three months ended March 31st, 2024, compared to the same period in 2023. The decrease in SDNA for the quarter ended March 31st, 2024 was primarily attributable to decreased personal costs related to the restructuring charge recorded in the quarter ended March 31st, 2023.

Bo Kruse: Selling general and administrative expenses decreased by <unk> eight.

Bo Kruse: 8 million to $11 4 million for the three months ended March 31st 2024 compared to the same periods in 2023.

Bo Kruse: The decrease in SG&A for the quarter ended March 31st 20 fall was primarily attributable to decreased personnel costs related to this restructuring charge recorded in the quarter ended March 31st Swingeing strength to strength.

Bo Kruse: We reported a net loss for the quarter ended March 31, 2024 of $6.6 million, or $0.15 per share, basic and diluted, compared to a net loss of $6.4 million, or $0.15 per share, basic and diluted, for the quarter ended March 31, 2023. As mentioned earlier, we ended the first quarter with cash and cash equivalents of $75.7 million, compared to $78.6 million at year-end 2023. The decrease was $2.9 million for the quarter. Importantly, we reduced our quarterly cash use from $13.1 million to $2.9 million, or by about 78% year-over-year in 2024 compared to 2023. Turning now to our guide.

Bo Kruse: We reported a net loss for the quarter ended March 31, 'twenty 'twenty four of $6 6 million or 15 cents per share basic and diluted compared to a net loss of $6 4 million or 15 cents.

Bo Kruse: Basic and diluted for the quarter ended March 31st 2023.

Bo Kruse: As mentioned earlier, we ended the first quarter with cash and cash equivalents of $75 7 million compared to $78 6 million at year end 2023. The decrease was $2 9 million for the quarter importantly, we reduced our <unk>.

Bo Kruse: Quarter cash used from $13 1 million to $2 9 million or by about 78% year over year in 2024 compared to 2023.

Bo Kruse: Turning now to our guidance.

Bo Kruse: We are reiterating our full year 2024 guidance. We continue to expect full year 2024 total Danielsa Net Product Revenues to be in the range of 95 to 100 million. We anticipate operating expenses to be in the range of 115 to 120 million, and we expect a cash burn for the full year 2024 of between 15 and 20 million. We continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently planned into 2027.

Bo Kruse: We are reiterating our full year 2024 guidance. We continue to expect full year 2024 children don't Hamzah net product revenues to be in the range of $95 million to $100 million.

Bo Kruse: We anticipate operating expenses to be in the range up.

Bo Kruse: <unk> hundred $15 million to $120 million.

Bo Kruse: And we expect a cash burn for the full year 'twenty 'twenty four between 15 and $20 million.

Bo Kruse: We continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently planned into 2027.

Bo Kruse: As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. For the purpose of this specific analysis of cash runway only, Danielsa net revenues are assumed to increase by 10 percent each year from 2024 through 2027. We hope to see a higher growth rate for Danielsa as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater physician adoption.

Bo Kruse: As we noted in previous quarters, the underlying assumptions for this guidance are important to understand for the purpose of this specific analysis of cash runway only Nielsen net product revenues I assume to increase by 10% each year from 'twenty to 'twenty full through 2027.

Bo Kruse: We hope to see a higher growth rate for 10 years as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater physician adoption.

Bo Kruse: In terms of development activities, we have assumed that all of our programs will be advanced at our own expense. Therefore, no new programs other than our planned studies and trials are assumed at this point for the purpose of this analysis. With a strong balance sheet and focused strategy, we believe Y-mAbs is well positioned to execute on its strategic mission and priorities and to support the delivery of multiple anticipated milestones ahead. Now, this concludes my financial update, and I'll now turn the call back to Mike.

Bo Kruse: In terms of development activities, we have assumed that all of our programs will be advanced at our own expense no new programs other than our planned studies and trials.

Bo Kruse: I assumed at this point for the purpose of this analysis.

Bo Kruse: Yes.

Bo Kruse: With a strong balance sheet focused strategy, we believe <unk> is well positioned to execute on our strategic mission and priorities and to support the delivery multiple anticipated milestones ahead.

Speaker Change: Now this concludes my financial update.

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

Michael Rossi: Thank you for that overview, Bo. Now, we'll open the line for questions. Operator?

Michael Rossi: Thank you for that overview boat.

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

Operator: At this time, we will conduct the question and answer session. If you would like to ask a question, please press star one on your telephone keypad now, and you'll be placed in the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star one on your phone now. And our first question comes from Alec Stranahan from Bank of America. Please go ahead, Alec.

Speaker Change: At this time, we will conduct a question and answer session. If you would like to ask a question. Please press star one on your telephone pad now.

Speaker Change: Youll be placed into the queue in the order received please be prepared to ask your question when prompted.

Michael Rossi: Once again, if you would like to ask a question. Please press star one on your phone now.

Michael Rossi: And our first question comes from Alex Stranahan from Bank of America. Please go ahead Alex.

Alec Warren Stranahan: Hey, guys. Thanks for taking our questions. Just a couple from me, maybe first for Sue.

Alec Warren Stranahan: Hey, guys. Thanks for taking our questions just a couple for me maybe first pursue.

Alec Warren Stranahan: Where do you see most of the current, in your term, Danielza growth coming from? Is it from activating new centers, or is it from repeat use from positions that have already treated patients previously with Danielza? And how are you maybe positioning your new marketing efforts to drive this? And then I've got a follow-up.

Alec Warren Stranahan: Where do you see most of the current and near term Danielle the growth coming from is it from activating new centers or is it from repeat usage from physicians, who have already treated patients previously with Daniels and how are you maybe positioning your new marketing efforts to drive this and then I've got a follow up.

Susan Smith: Good morning, Alex. Thanks for the question. The marketing mix for us is a combination of both of the things that you said. I think the majority of the sales are coming from driving more use in the high-volume centers, which is a very big focus for us. And as you heard, we've been added to three new formularies in the first quarter, which we're pulling through. So we're very excited about that. The new campaign is also opening up greater education around the partial response to induction patient, which is another important lever for us this year. And the new campaign does a very nice job of demonstrating our data and value in that setting. And I think, I'm sorry, what was the second part of your question?

Speaker Change: Good morning, Alex Thanks for the question.

Alec Warren Stranahan: But no marketing next process is a combination of both of the things that you said I think the majority of the sales is coming from driving more use in the high volume centers, which is a very big focus for us and as you heard we've been added to several three new formularies in the first quarter, which were pulling trail. So we're very excited about that the new <unk>.

Alec Warren Stranahan: Campaign is also opening up greater education around that.

Alec Warren Stranahan: Part D. Partial response, two induction patient, which is another important lever for us. This year and then you campaign does a very nice job of demonstrating our data and value in that setting.

Alec Warren Stranahan: So we increased the breadth and the depth.

Alec Warren Stranahan: And in the <unk>.

Alec Warren Stranahan: <unk> with.

Alec Warren Stranahan: Existing and new accounts.

Speaker Change: And I think I'm, sorry, what was the second part of your question.

Susan Smith: I think you answered it by explaining just how you're positioning the new marketing effort.

Speaker Change: I think you answered it just how youre positioning the new marketing efforts.

Susan Smith: Again, it's demonstrating our value in two different parts of the patient journey, the patients that have an incomplete response to induction, separate from the later stage after frontline where they have a relapse after prior treatment.

Speaker Change: Yes, yes, again, it's demonstrating our value in two different parts of the patient journey in patients that have an incomplete response to induction separate from the later stage after frontline where they have a relapsed after prior treatment.

Alec Warren Stranahan: Okay. Great. That makes sense. And then maybe one for Mike.

Speaker Change: Okay, Great that makes sense and then maybe one for Mike you.

Michael Rossi: You mentioned in your prepared remarks the potential to expand SADA beyond oncology. I wonder what that could sort of look like and whether there's any example applications you can provide, maybe based on your preclinical work. Thanks.

Michael Rossi: You mentioned in your prepared remarks.

Michael Rossi: To expand saw that beyond oncology I wonder what that can sort of look like and whether there is any example of applications you can provide.

Michael Rossi: Maybe based on your preclinical work thanks.

Michael Rossi: Alec, thank you. You know, as we look at radioactive material and what we do from both the diagnostic and the therapeutic point of view. There are opportunities to look at multiple receptor modulated diseases. You know, where we started in Theranostics 80 years ago was in endocrinology and treating hyperthyroidism. So, you know, before it went on to thyroid cancer. So as we look at this, there are many receptor-modified diseases where you need to either decrease the receptor response.

Michael Rossi: Alex Thank you.

Michael Rossi: We look at it radioactive material and what we do from both the diagnostic and therapeutic.

Alec Warren Stranahan: There is opportunities to look at multiple receptor modulator diseases.

Alec Warren Stranahan: Where we started and they're gnostics 80 years ago, Luis and endocrinology and treating hyperthyroidism. So before it went on to thyroid cancer. So as we look at the many receptor modulator diseases, where you need to either decrease the receptor response.

Michael Rossi: Or to just decrease the overall production of, you know, hormones, things like that; you have the opportunity to treat with radioactive materials and treat in a very safe and effective way. So, you know, I wouldn't limit us to just oncology as we look at the opportunities that lie ahead for these products.

Alec Warren Stranahan: For two just decrease the overall production.

Alec Warren Stranahan: Hormones things like that you have the opportunity to treat with radioactive materials and treating the very safe and effective way so.

Alec Warren Stranahan: Not limit us to just oncology and as we look at the opportunities that lie ahead for these products.

Alec Warren Stranahan: Great, thank you. Thanks.

Speaker Change: Great. Thank you.

Speaker Change: Thank you Alex.

William Patrick Maughan: And our next question comes from Bill Mahan from Canaccord Genuity. Please go ahead, Bill.

Speaker Change: And our next question comes from Bill Mahan from Canaccord Genuity. Please go ahead bill.

William Patrick Maughan: Hi, thanks for taking the question. Good morning.

William Patrick Maughan: Hi, Thanks for taking the question. Good morning, I just wanted to take a quick look at ex U S. Daniels.

Michael Rossi: I just wanted to take a quick look at Ex-U.S. Danielza, understanding that bulk ordering and timing of those orders can affect revenue numbers. Do you have visibility into vial sales, underlying demand? And then just kind of going forward, do you expect – we appreciate that Danielza is being broken out U.S. versus Ex-U.S. now? Do you expect the U.S. to remain clearly the main driver going forward, or will the rest of the world at some point, you know, take some more share of the growth story here?

William Patrick Maughan: Understanding that bulk ordering and timing of those orders can affect revenue numbers do you have visibility into the vial sales.

William Patrick Maughan: The underlying demand.

William Patrick Maughan: And then just kind of going forward do you expect.

William Patrick Maughan: We appreciate that Daniels is being broken out U S versus ex U S. Now do you expect U S to be remain clearly the main driver going forward or will the rest of the world at some point.

William Patrick Maughan: Take take some more share of the growth story here.

Michael Rossi: You know, Bill, thank you for that, and I will let Sue answer the majority of it, but what I will say is, as we look at this, we have visibility into some of the bulk orders coming in for the remainder of the year, XUS, so we're very confident in our forecasting and where we are. Now there will be additional growth as we move into these launch markets and have some real opportunity to continue the growth.

Speaker Change: Bill Bill Thank you for that and.

William Patrick Maughan: I will let sue answer the majority of it but what I will say is as we look at this we have visibility to some of the bulk orders coming in for the remainder of the year ex U S. So we're very confident in our.

William Patrick Maughan: Our forecasting and where we are.

Susan Smith: Now there will be additional growth as we move into these launch markets.

Susan Smith: And have some real opportunity to continue to growth I think as you look at this we're in the 80 20 range today with U S and ex U S with U S being the driver U S will continue to be in the driver's seat.

Michael Rossi: I think as you look at this, we're in the 80-20 range today with the U.S. and ex-U.S., with the U.S. being the driver. It will continue to be in the driver's seat because as we continue to grow the U.S., we'll continue to grow the ex-U.S. market, but as a direct market, it contributes more to the overall top and bottom lines. So, I think that 80-20 mix is something that you'll see without a massive spread moving forward, but we may see some additional contribution from the ex-U.S. market beyond the U.S. as the U.S. does tend to mature over a period of time. And Sue, if there's anything that you'd like to add?

Susan Smith: Because as we continue to grow the U S. We will continue to grow the ex U S market.

Susan Smith: But as a direct market it contributes more to the overall top and bottom lines as.

Susan Smith: Compared to ex U S. I think that 80 20 mix is something that youll see without massive spread moving forward, but we may we may see some additional contribution from the ex U S market beyond the U S. As the U S does tend to mature over a period of time and so if there's anything that you'd like to.

Susan Smith:

Susan Smith: I think you said it well. I think we have meetings regularly with all of our partners, so we have a very good line of sight in terms of the breakout of their assumptions for their forecasts and also the activities that they are doing to drive their launches in the case of ADM and their ongoing sales in the case of Cyclone and others. So our company is well aligned with its stakeholders at our partner companies and has an ongoing dialogue in terms of the details behind the numbers.

Speaker Change: I think you said it well I think we do have meetings regularly with all of our partners. So we have a very good line of sight in terms of the break out of their assumptions for their forecast and also the activities that they are doing to drive their launches in the case of ADM and the ongoing sales.

Speaker Change: I don't know places cyclone and others so our.

Speaker Change: Our company is well aligned to their.

Speaker Change: Stakeholders of our partner companies and have an ongoing dialogue in terms of the details behind the numbers, so and I agree with what Mike said in terms of the breakout of the 80 20.

Susan Smith: And I agree with what Mike said in terms of the breakout of the AD20. And I think everyone knows the U.S. is the biggest market in terms of top and bottom line contribution, which probably will not change moving forward.

Speaker Change: Everyone knows the U S.

Speaker Change: The biggest market in terms of top and bottom line contribution, which probably will not change moving forward.

William Patrick Maughan: Okay, and then, in the U.S., obviously, Danielza is a more important drug to Y-mAbs than Unituxim is to United Therapeutics, so as you continue to grow market share and more doctors start to write Danielza, Do you-are you sensing sort of additional counter-detailing or pushback from the other competitor on the market, or do you feel that, you know, your share gains are just kind of being-being tolerated and you can continue to grow, you know, along the plans that you're implementing?

Speaker Change: Okay and then just.

Speaker Change: In the U S. Obviously, Danielle this is a more important drug to why not then units Hudson as to United Therapeutics. So as you continue to grow market share and more and more doctors start to write Daniels.

Speaker Change: Do you are you sensing sort of.

Speaker Change: Additional counter detailing or pushback from the other competitor on the market or do you feel that.

Speaker Change: Share gains or just kind of being being tolerated and you can continue to grow.

Speaker Change: Along the plans that you're implementing.

Michael Rossi: Well, I think, you know, our growth speaks for itself, and we do not hear, to my understanding, they do not have a sales force. So, you know, I think our share of voice is the greatest, and from market research, we are recognized as the number one company in our commitment to pediatric neuroblastoma among treaters. So, we continue to build those relationships with the key accounts, and we're not hearing a lot of noise from U.S. World Med.

Speaker Change: Well I think you know.

Speaker Change: Our growth speaks for itself.

Speaker Change: And we do not.

Speaker Change: Sure.

Speaker Change: I understand.

Speaker Change: They do not have a sales force.

Speaker Change: So I.

Speaker Change: I think our share of voice is the greatest and from market research. We are recognized as the number one company in.

Speaker Change: Our commitment to pediatric neuroblastoma among traders.

Speaker Change: So we continue to.

Speaker Change: To build those relationships with the key accounts and.

Speaker Change: We're not hearing a lot of noise from you at 12 months.

Speaker Change: Great. Thank you.

Speaker Change: Mhm.

Etzer Darout: And our next question comes from Etzer Darout from PCMO Capital Market. Please go ahead, Etzer.

Speaker Change: Okay.

Speaker Change: And our next question comes from Edgar drought from BMO capital markets. Please go ahead Sir.

Michael Rossi: Hi, this is Lucan Forester. Thanks for taking my question. A quick one on CD38-SADA. Do you think that the cadence of data disclosures will follow a similar pathway that GD2-SADA has had? Like, will we get an initial imaging data drop followed by a complete Phase 1a set? Now, Walter, thank you for the question.

Speaker Change: Hi, This is Luke on for Ed. Thanks for taking my question a quick one.

Speaker Change: CD 38 Sada do.

Speaker Change: Do you think that the cadence of data disclosures will follow a similar.

Luke: Pathway that gd to sort of have like when we get an initial imaging data drop followed by <unk>.

Speaker Change: <unk> phase one.

Speaker Change: Thanks.

Michael Rossi: No, well, thank you for the question on that. I think as we look at this, there may be some data that we release early just to show kind of where we are. But at the end of the day, I think it's more meaningful to look at a significant number of patients, collect that data, and come back with the learning. As far as the timing of the cadence, you know, the hope is now that we've had GD2 in patients in our 1001 study, that 1201 will recruit a little bit more quickly.

Sada: No well. Thank you for the question on that I think as we look at this.

Speaker Change: There may be some data that we really thoroughly.

Speaker Change: Just to show kind of where we are but at the end of the day I think it's more meaningful to look at a significant number of patients collect that data and come back with the learning.

Speaker Change: As far as the timing of the cadence. The hope is now that we've had.

Speaker Change: G D. Two in patients in our tunnel, one study that 12 or one of our crude a little bit more quickly.

Michael Rossi: And we could potentially get some of this, using the learnings from our 1001 to expedite our 1201. But that being said, my goal would be to put as much meaningful data together and look at it all in one consistent data set.

Speaker Change: And we could potentially get some of this use the learnings from our channel wanted to expedite or 12 O. One.

Speaker Change: But that being said my goal would be to put as much meaningful data together and look at it all in one consistent.

Speaker Change: One consistent data with us.

Speaker Change: Okay.

Speaker Change: Okay. Thanks.

Speaker Change: I appreciate it.

David Matthew Nierengarten: And our next question comes from David Nierengarten from Wedbush Securities. Please go ahead, David.

David Matthew Nierengarten: And our next question comes from David near Garten from Wedbush Securities. Please go ahead David.

David Matthew Nierengarten: Hey, thanks for taking the questions. I have one on SADA, and that is, do you have any patients yet that have entered into Part C, and kind of where are you on dosing, and dose escalation for the 1001 study? Thanks.

David Matthew Nierengarten: Hey, Thanks for taking my question I have one on.

David: Do you have any patients.

David: Yet in that have entered into the part C.

David: Kind of where we.

David Matthew Nierengarten: Where are you on those.

Speaker Change: Dose dosing dose escalation.

David: Sure.

David: 101.

Speaker Change: I wanted to study thanks.

Michael Rossi: Thank you, David. Now, we're still in Part A, and we have not moved to Part B yet. So where we are, we've done the first 14 patients. We dose-escalated up to 3 milligrams per kilogram, and we'll be moving on to our fifth cohort shortly. However, until we complete Part A, the goal in Part A is to eliminate the two variables of protein load and the dose time to the radioisotope. Once those two variables are narrowed down, then we'll move into Part A, where we escalate the activity in the isotope and then move to Part B. Part C, which is repeated up to five cycles.

Speaker Change: Yeah. Thank you David we're not we're still in part a.

David: And we have not moved the part B, So where we are we've done the first 14 patients.

David: Dose escalated up to three milligrams per kilogram and we'll be moving on to our fifth cohort shortly.

Michael Rossi: However.

Michael Rossi: Until we complete part a.

Michael Rossi: The goal in part a is to eliminate the two variables of protein load and the dose timing to the radioisotope. Once those two variables are narrowed down number move into part a where we escalate the activity and the isotope and then move to <unk>.

Michael Rossi: Part C, which was repeat up to five cycles.

David Matthew Nierengarten: Maybe a quick follow-up, if I could, on the SADA protein dose and dose escalation. Do you expect the targeting SADA molecules to have different dosing levels, depending on the tumor type in the future, or do you think you'll be able to saturate the target and then figure out the appropriate radiation dose? Yeah.

Speaker Change: Maybe a quick follow up if I could on the.

David Matthew Nierengarten: Yes.

David Matthew Nierengarten: Coaching dose the dose escalation do you expect.

David Matthew Nierengarten: The.

David Matthew Nierengarten:

David Matthew Nierengarten: Targeting.

David Matthew Nierengarten: Targeting sort of molecules to have different.

David Matthew Nierengarten: Dosing levels.

David Matthew Nierengarten: Depending on the tumor type in the future or.

David Matthew Nierengarten: Do you think you'll kind of be able to saturate the target and then figure out.

David Matthew Nierengarten: Radiation dose.

Michael Rossi: Yeah, I think that's part of our learnings moving forward. So I want the data to take us to the right conclusion. So at this point, we're really trying to determine what the optimal protein load is, and once we determine that, there may be variations from cytomolecule to cytomolecule. There may be some variations patient to patient, but at the end of the day, we want to make this as simple for healthcare practitioners as possible and give both the practitioner and the patient the best opportunity for effective therapy.

David Matthew Nierengarten: Yeah, I think that's part of our learnings moving forward and so I want the data to take us to the right conclusion. So at this point, we're really trying to determine what the optimal protein loaders and once we determine that there may be variations from Sato molecule to settle molecule there may be some variations patient to patient.

Michael Rossi: <unk>.

Michael Rossi: But at the end of the day, we want to make this as simple for health care practitioners as possible.

Michael Rossi: Both the practitioner and the patient the best opportunity for an effective therapy. So we're taking in all of the data that we can we'll collect that and then take a qualified step backwards.

Michael Rossi: So, we're taking in all of the data that we can. We'll collect that and then take a qualified step backwards to let the data dictate where we go and what that looks like from both a protein loading and dosimetry perspective. Okay. And our next question comes from Michael from Morganstown.

Michael Rossi: To let the data dictate where we go and what that looks like from both a protein loading the dosimetry perspective.

Michael Rossi: Got it thanks.

Michael Eric Ulz: And our next question comes from Michael Ulz from Morgan Stanley.

Michael Rossi: Thank you and our next question comes from Mike <unk> from Morgan Stanley. Please go ahead Mike.

Michael Eric Ulz: Hi, Good morning. This is Robert on for Mike. Thanks for taking our questions just.

Michael Eric Ulz: Danielle so trends for the remainder of the year are.

Michael Eric Ulz: Are you expecting consistency from quarter to quarter or do you expect to see more volatility. Thanks.

Michael Eric Ulz: Yes.

Michael Rossi: Thanks, Mike. All right, go ahead, Sue.

Michael Eric Ulz: Thanks, a lot. Thank you Ron.

Sue: Alright gotcha.

Susan Smith: I think in terms of quarter-to-quarter, there is some seasonality, but again, we reiterate that overall. We anticipate there will be a strong attainment of the forecast number for this year. So the consistent trend is there, and with the new programs in place, we're starting to see those kick in, so I think that we'll have steady growth, perhaps some seasonality in the summer, which we've seen every year.

Sue: Oh, sorry.

Sue: Yeah, I think in terms of quarter to quarter.

Susan Smith: There is some seasonality.

Susan Smith: But again, we reiterate that overall, we anticipate there will be a strong.

Susan Smith: The attainment of the of the global I'm, sorry, the forecast number for this year.

Susan Smith: So the.

Susan Smith: Consistent trend is there and with the new programs in place, where we're starting to see those kick in so I think that will have a steady growth.

Susan Smith: Some seasonality in the summer, which we've seen every year since launch.

Speaker Change: Thank you.

Gerard: Hey, Gerard.

Susan Smith: And at this time there are no further questions I would like to turn the call back over to Michael Rafi for closing remarks.

Michael Rossi: And at this time, there are no further questions. I would like to turn the call back over to Michael Rossi for closing remarks.

Speaker Change: Well. Thank you all for joining us today to discuss the progress made during the first quarter of this year.

Michael Rossi: Well, thank you all for joining us today to discuss the progress made during the first quarter of this year. With a strong financial foundation from Danielle's commercial success and our responsible capital allocation strategy, we're uniquely positioned to continue top-line growth while advancing the clinical development of our differentiated radioimmune therapy platform, SADAPRIT, and potentially deliver better and safer therapeutic options in the treatment of a variety of cancers. We look forward to seeing many of you at upcoming investor and medical meetings, in particular at ASCO and SNMM. Thank you, and have a great day!

Michael Rossi: With strong financial foundation from Daniela <unk> commercial success in a responsible capital allocation strategy.

Michael Rossi: Uniquely positioned to continued topline growth, while advancing the clinical development of our differentiate at radio immune therapy platform sort of print.

Michael Rossi: And potentially deliver better and safer therapeutic options in the treatment of a variety of cancers.

Michael Rossi: Look forward to seeing many of you at upcoming Investor and medical meetings in particular, <unk> and SLM EMI.

Michael Rossi: You then have a great day.

Operator: This concludes today's conference call. Thank you for attending.

Speaker Change: This concludes today's conference call. Thank you for attending.

Operator: The host has

Speaker Change: The House has ended this call goodbye.

Operator: I ended this call. Goodbye.