Q2 2024 Y-mAbs Therapeutics Inc Earnings Call

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

Operator: Good morning, and welcome to Y-mAbs Therapeutics, Inc.'s earnings conference call for the second quarter of 2024. At this time, all participants are in a listen-only mode.

Operator: Instructions for the question-and-answer session will follow today's prepared remarks. As a reminder, today's conference will be recorded. I will now hand it over to Y-mAb's Head of Investor Relations, Courtney Dugan. Please go ahead.

Speaker Change: I will now hand, it over to <unk> head of Investor Relations. According to again. Please go ahead.

Courtney Dugan: Thank you, Operator, and good morning, everyone. Welcome to the Y-mAbs second quarter 2024 Financial Results Conference call. We issued a press release with our results this morning before the market opened. The press release and accompanying slides are available on the Investor Relations section of our website. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined by 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.

Speaker Change: Thank you operator, and good morning, everyone welcome to the wine as second quarter 2024 financial results Conference call.

Speaker Change: We issued a press release with our results. This morning before the market opened the press release and accompanying slides are available on the Investor Relations section of our website let.

Courtney Dugan: Expectations with respect to early trial data. Current and future clinical and preclinical studies and our research and development program. Expectations related to the timing of the initiation and completion of regulatory submissions. Regulatory, marketing, and reimbursement approvals, including statements with respect to future development of other development programs, potential for Danielle's territory and label expansion, a potential of an 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, capital expenditure requirements, and other statements that are not historical facts.

Speaker Change: Let me quickly remind you that the following discussion contains certain statements that are considered forward looking statements as defined by the private Securities Litigation Reform Act of 1995.

Speaker Change: Such statements include but are not limited to statements about our business model and development commercialization and product distribution plans.

Speaker Change: Expectations with respect to early trial data.

Speaker Change: Current and future clinical and preclinical studies, and our research and development programs.

Speaker Change: Expectations related to the timing of the initiation and completion of regulatory submissions.

Speaker Change: Regulatory marketing and reimbursement approvals, including statements with respect to future development or other development programs potential for Daniels of territory and label expansion potential as an advancement as fodder.

Speaker Change: Collaborations or strategic partnerships and the potential benefits thereof.

Speaker Change: Expectations related to our anticipated cash runway and cash burn and the sufficiency of our cash resources and assumptions related there too.

Speaker Change: Guidance and expectations for 2024, and beyond and our financial performance, including our estimates regarding revenues expenses and capital expenditure requirements and.

Speaker Change: 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 previously filed annual report on Form 10-K for the year ended December 31, 2023, Quarterly Report and Form 10-Q for the quarter ended March 31, 2024, and the Company of Quarterly Report and Form 10-Q for the quarter ended June 30, 2024, to be filed with the SEC today. I would now like to turn the call over to our President and Chief Executive Officer, Mike Rossi. Thank you, Courtney.

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 previously filed annual report.

Speaker Change: On Form 10-K for the year ended December 31 2023.

Speaker Change: Quarterly report on Form 10-Q for the quarter ended March 31, 2024, and the company's quarterly report on Form 10-Q for the quarter ended June 30th 2024 to be filed with the SEC today.

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

Mike Rossi: Thank you Gordon and good morning.

Mike Rossi: And thank you for joining us I have.

Michael Rossi: Good morning, and thank you for joining us. I have with me today our Chief Commercial Officer, Sue Smith. Chief Medical Officer, Dr. Vinesh Rajah, and our new Chief Financial Officer, Pete Pfreundschuh. This morning, I will begin by reviewing key financial and operational highlights from the second quarter of 2024, including Daniella's sales performance and the clinical progress of our radiotherapy clinical programs, utilizing our self-assembly, disassembly, pre-targeted radioimmune therapy, or SADAPRT technology platform.

Speaker Change: With me today are chief commercial officer Sue Smith.

Speaker Change: Medical officer, Dr, but naturally draw and our new Chief Financial Officer, Pete friendship.

Speaker Change: This morning, I will begin by reviewing key financial and operational highlights from the second quarter of 2024, including Daniels's sales performance and the clinical progress of our radio therapy clinical programs utilizing our self assembly disassembly pre targeted radio immune therapy or sort of print.

Michael Rossi: Next, Sue will provide details around our global Danielsa sales in the second quarter. Vignesh will then provide updates around our ongoing mexidimab ISS clinical trial. Pete will then review our second quarter of 2024 financial performance, our cash resources, and provide an update to our full year 2024 guidance before we open the line for Q&A. Let's begin with key highlights for the second quarter of 2024, starting with Danielle's, As many of you know, neuroblastoma is the most common cancer in infants and the third most common cancer in children.

Speaker Change: <unk> platform.

Speaker Change: Next shoe will.

Speaker Change: Details around our global Daniels of sales in the second quarter.

Nash: The Nash will then provide updates around our ongoing next at about of ISS clinical trials.

Pete will then review our second quarter of 2024 financial performance, our cash resources and provide an update to our full year 2024 guidance before we open the line for Q&A.

Speaker Change: Let's begin with key highlights for the second quarter of 2024, starting with Daniels, though.

Daniels: As many of you know neuroblastoma is the most common cancer in infants and the third most common cancer in children.

Michael Rossi: Our commercial drug, Danielza, is a leading anti-GD2 therapy in the U.S. and remains critically important therapy for children with relapsed refractory high-risk neuroblastoma. Danielza is humanized and is the only FDA-approved immunotherapy for high-risk neuroblastoma that is specifically designed for children who have an incomplete response to induction or relapse therapy and also have disease in the bone and or bone marrow. Importantly, Danielza can be administered either outpatient or inpatient, depending on the specific needs of the child and his or her family.

Speaker Change: Commercial drug Daniels are the leading anti <unk> therapy in the U S and remains critically important therapy for children with relapsed refractory high risk neuroblastoma.

Speaker Change: Danielle is humanized and is the only FDA approved immunotherapy for high risk neuroblastoma that is specifically designed for children, who have an incomplete response to induction.

Or relapsed therapy, and also have disease in the bone and or bone marrow.

Speaker Change: Importantly, daniels it can be administered either outpatient or inpatient depending on the specific needs of the child and his or her family.

Speaker Change: In the second quarter of 2024, we achieved total Daniels of net product revenue of $22 $8 million up 10% from the second quarter of 2023.

Michael Rossi: In the second quarter of 2024, we achieved total Danielza net product revenue of $22.8 million, up 10% from the second quarter of 2023. The increase was primarily driven by a boost in international orders from our partners WEP in Western Europe and ADEA in Latin America, which includes the commercial launch in Brazil and Mexico. For the first six months of the year, we achieved total Danielta net product revenues of $42.2 million, up 3% from the same period in 2023. The increase was primarily driven by an increase in U.S. revenues in the first half of 2024 compared to the year prior period. We are continuing to drive Daniella forward and are penetrating more centers.

Speaker Change: The increase was primarily driven by a boost in international orders from our partners web in Western Europe, and Asia, and Latin America, which includes the commercial launch in Brazil and Mexico.

Speaker Change: For the first six months of the year, we achieved total Daniels in net product revenues of $42 $2 million up 3% from the same period in 2023.

Speaker Change: The increase was primarily driven by an increase in U S revenues in the first half of 2024 compared to the prior period.

Speaker Change: We are continuing to drive Daniels afford and are penetrating more centers.

Michael Rossi: In the second quarter alone, Danielle Hielse has been added to two new hospital formularies. Well, we saw increased market and clinical trial competition for patients in the U.S. during the second quarter. We view this as a net positive for patients and families. As a company, we are driving investments around direct-to-parent educational efforts focused on Danielta differentiators in bone and bone marrow. The Y-mAbs team has deep knowledge of the market and is specifically dedicated to pediatric neuroblastoma. Ex-US, we saw a boost in orders in the second quarter of this year as compared to the first quarter of this year. Our partner ADM executed the Danielza commercial launch in both Brazil and Mexico.

Speaker Change: In the second quarter alone didn't hear all of that has been added to two new hospital formularies.

Speaker Change: We saw increased market in clinical trials competition for patients in the U S. During the second quarter. We view this as a net positive for patients and families.

Speaker Change: As a company we are driving investments around direct to parent educational efforts focused on Daniels differentiators in bone in bone marrow.

Speaker Change: <unk> team has deep knowledge of the market and it's specifically dedicated to pediatric neuroblastoma.

Speaker Change: Ex U S. We saw a boost in orders in the second quarter of this year as compared to the first quarter of this year.

Speaker Change: Our partner AGM executed at the Daniels and commercial launch in both Brazil and Mexico.

Michael Rossi: We're very pleased with how these launches are progressing and look forward to providing further updates in future quarters. In Asia, our Cyclone partner continues to expand the use of Danielle's in China. Additionally, we're thrilled to have received approval for Danielsa in Hong Kong and look forward to working with our Eastern Asia partner, Cyclone, in anticipation of their commercial launch of Danielsa in Hong Kong. Our European named patient program with WEP Clinical is also continuing to progress as we support the needs of children with high-risk relapsed refractory neuroblastoma in Western Europe.

Speaker Change: We're very pleased with how these launches are progressing and look forward to providing further updates in future quarters.

Speaker Change: In Asia, our cyclone partner continues to expand use of Daniels in China.

Speaker Change: Additionally, we're thrilled to have received approval for Danielle So in Hong Kong and look forward to working with our Eastern Asia partner cyclone in anticipation of their commercial launch of Daniels in Hong Kong.

Speaker Change: Our European named patient program with wet clinical is also continuing to progress as we support the needs of children with high risk.

Speaker Change: Relapsed refractory neuroblastoma in Western Europe.

In addition to our new approval in Hong Kong, we entered into distribution agreement with T. R. Pharm for patient named program distribution of Daniels in Turkey.

Michael Rossi: In addition to our new approval in Hong Kong. We entered into distribution agreement with TR Pharm for patient name program distribution of Danielle's N-Turk. We also plan to submit a BLA for Danielle in Argentina later this year.

Speaker Change: We also plan to submit a BLA for Daniels in Argentina later this year.

Michael Rossi: We remain confident in our U.S. commercial strategy and trajectory and in the continued ex-U.S. expansion of Danielle's. Vignesh will provide updates on our investigator-sponsored trials of an exitomab later during this call. Let me now shift to our clinical progress of our SADA PrEP program. We are currently in Part A of our GD2-SADA Phase 1 trial evaluating the safety and tolerability of the SADA PRIT in the treatment of GD2-positive solid tumors, including small cell lung cancer, sarcomas, and malignant melanoma.

Speaker Change: We remain confident in our U S commercial strategy and trajectory and then the continued ex U S expansion of Daniels.

The Nash will provide updates on our investigator sponsored trials over the next it about them later during this call.

Speaker Change: Let me now shift to our clinical progress of our sort of prep programs.

Nash: We are currently in part a of our G. D to start a phase one trial evaluating the safety and Tolerability of the solder in the treatment of Gd to positive solid tumors, including small cell lung cancer, Sarcomas and malignant melanoma.

Michael Rossi: As a reminder, this Phase 1 Dose Escalation Single-Arm Multi-Center Safety Study has three parts. Part A, which we are currently in, is structured to demonstrate the safety profile of the protein while it explores dose finding for the GD2 SADA molecule and testing of dose intervals of two to five days between the protein and the lutetium-177 DOTA payload. Part B determines the optimal dose of Lutetium-177 DOTA.

Nash: As a reminder, this phase one dose escalation single arm Multicenter safety study has three parts.

Jorge: Jorge which we're currently in is structured to demonstrate the safety profile of the protein while it explores dose finding for the G D to Saddam molecule and testing of dose intervals of two to five days between the protein and the lutetium 177, daughter payload.

Jorge: Part be determined the optimal dose of lutetium 177 data and.

Michael Rossi: And Part C evaluates the initial signs of efficacy using repeat dosing. We are pleased with how the trial is progressing. It has advanced through Cohort 4. We are currently in Cohort 5. We have dosed a total of 17 patients to date in Part A of this trial. We currently have six sites open and plan to continue adding additional sites. We are encouraged by what we've seen so far. 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 a proof of concept in humans that GD2 SOTIC can both find and bind to tumors.

Jorge: In part C evaluates the initial signs of efficacy using repeat dosing.

Jorge: We are pleased with how the trial is progressing.

Jorge: Advanced through cohort four we are currently in cohort five.

Jorge: Dosed a total of 17 patients to date in part a of this trial.

Jorge: We currently have six sites open and plan to continue adding additional sites.

Jorge: We are encouraged by what we've seen so far.

Jorge: 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.

Jorge: Based on the spec C T scans and PK activity, we have seen to date. We believe we have demonstrated proof of concept in humans that GTT tzaddik can both find and buy into tumors.

Michael Rossi: It is important to note that these early data are not complete and not necessarily indicative of full results or ultimate success of the trials or the SADA development program. We expect to complete Part A of the Phase 1 study by the end of this year and will present the full data set from Part A at a medical meeting in early 2025. And the data readout from Part A of the trial. Our objective is to demonstrate the safety profile of the protein, and determine the optimal timing to administer the radionuclide, all of which will inform Part 2.

Jorge: It is important to note that these early data are not complete.

And not necessarily indicative of full results or ultimate success of the trials or the sort of development program.

Jorge: We expect to complete part a of the phase one study by the end of this year and we want to present the full data set from par day at a medical meeting in early 2025.

Jorge: And the data readout from part a of the trial. Our objective is to demonstrate the safety profile of the protein and determine the optimal timing to administer the radionuclide all of which will inform part b.

Michael Rossi: In addition, we plan to show additional scan images and PK data. Our second SADA PRIP program is CD38 SADA, which we plan to first study in the treatment of non-Hodgkin's lymphoma, focusing on B and T cell lymphoma. This will be our first SADA program in circulating tumors. Our Plain Phase I follows a comparable design toward GD-2 Sonata Phase I trial, which you can see here. We have selected the first six sites and expect to dose the first patient in the second half of this year.

Jorge: In addition, we plan to show additional scan images and PK data.

Speaker Change: Our second thought of print program with CD 38 Saada.

Speaker Change: Which we plan to first study of the treatment of non Hodgkin's lymphoma, focusing on B and T cell lymphoma.

This will be our first sort of program in circulating tumors.

Speaker Change: Our planned phase one follows a comparable designed toward Gd toussaud, a phase one trial, which you can see here.

Speaker Change: We have selected the first six sites and expect to dose the first patient in the second half of this year.

Speaker Change: We strongly believe <unk> has the potential to shift the radiotherapy treatment paradigm across a variety of cancers and potentially even in indications beyond oncology.

Michael Rossi: We strongly believe SADAPRIT has the potential to shift the radiotherapy treatment paradigm across a variety of cancers and potentially even in indications beyond oncology. All while avoiding many of the infrastructure, manufacturing, and administration challenges many other technologies are facing.

Speaker Change: All while avoiding many of the infrastructure manufacturing and administration challenges with many other technologies are facing.

Michael Rossi: We look forward to providing further updates on our SADA program. Going forward. Our team remains steadfast in our collective commitment to improve patient lives, and I'm very proud of the progress we continue to make to advance our novel therapies through clinical development. I will now pass the call over to Sue Smith to provide further color on global Danielle's of sales for the second quarter of 2024. Thank you, Mike, and good morning, everyone.

Speaker Change: We look forward to providing further updates on our <unk> programs going forward.

Speaker Change: Our team remains steadfast in our collective commitment to improve patient lives and I'm very proud of the progress we continue to make to advance our novel therapies through clinical development.

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

Sue Smith: Thank you, Mike and good morning, everyone. As you heard from Mike. We're pleased with the commercial traction of Danielle that both in the U S and across our ex U S markets.

Susan Smith: As you heard from Mike, we're pleased with the commercial traction of Danielza both in the U.S. and across our ex-U.S. markets. As more competition arises in the form of new market entrants and clinical trials, we're continuing to sharpen our strategic commercial efforts and remain confident in the unique features and benefits Danielza is bringing to neuroblastoma patients. In the second quarter of 2024, total worldwide Danielza net product revenues were $22.8 million, a 10% increase compared to the same period last year, primarily driven by an increase in international orders.

Sue Smith: More competition arises in the form of new market entrants in clinical trials, we're continuing to sharpen our strategic commercial efforts and remain confident in the unique features and benefits Daniels that it's bringing to neuroblastoma patients.

Speaker Change: In the second quarter of 2020 for total worldwide Daniels in net product revenues were $22 8, million% to 10% increase compared to the same period last year, primarily driven by an increase in international waters.

Susan Smith: Breaking out U.S. and ex-U.S., in the U.S., our second quarter 2024 Danielza net product revenues were $15.2 million, a decrease of 4% compared to the second quarter of 2023. The Q2 softness was driven by a volume decrease due to the launch of competing therapy in another class of agents and some ongoing clinical trial activity.

Speaker Change: Breaking out U S and ex U S. In the U S. Our second quarter 2024, Daniels that net product revenues were $15 $2 million, a decrease of 4% compared to the second quarter of 2023.

Speaker Change: Q2 softness was driven by a volume decrease due to the launch of competing therapy in another class of agents and some ongoing clinical trial activity.

Susan Smith: Ex-U.S., our second quarter 2024 Danielle's Net Product Revenues were $7.6 million, an increase of 55% compared to the second quarter of 2023. In the U.S., our dedicated team is continuing to advance our new Danielza campaign aimed to reposition and elaborate on Danielza's differentiating characteristics in the treatment of high-risk neuroblastoma for patients who are refractory or have experienced incomplete response to induction therapy in their bone and bone marrow. The critical piece of this new campaign highlights Danielle's performance in two different patient populations.

Speaker Change: Ex U S. Our second quarter 2024, Daniels in net product revenues were $7 6 million, an increase of 55% compared to the second quarter of 2023.

Speaker Change: In the U S. Our dedicated team is continuing to advance our new Daniels at campaign aimed to reposition and elaborate on Daniels is differentiating characteristics in the treatment of high risk neuroblastoma for patients who are refractory or have experienced incomplete response to induction therapy and their bone.

Operator: Good morning, and welcome to Y-mabs Therapeutics, Inc., earning conference call for the second quarter of 2024. At this time, all participants are in a listen-only mode. Instructions for the question and answer session will follow today's repair marks. As a reminder, today's conference will be recorded.

Speaker Change: In bone marrow.

Speaker Change: The critical piece of this new campaign highlights Daniels this performance in two different patient populations.

Susan Smith: Those patients with an incomplete response to induction therapy and patients who are relapsed after prior therapy. This campaign also highlights Danielle's response in children who had previously received anti-GD2 therapy. Additionally, we recently rolled out a new direct-to-consumer campaign that specifically speaks to the needs of parents.

Speaker Change: Those patients with an incomplete response to induction therapy and patients who are relapsed after prior therapy.

Courtney Dugan: I will now hand it over to Y-mabs head of investor relations, Courtney Dugan. Please go ahead. Thank you, operator, and good morning, everyone.

Speaker Change: This campaign also highlights Daniels's response in children, who had previously received anti G. D G therapy.

Courtney Dugan: Welcome to the Y-mabs second quarter of 2024. For financial results, conference call. We issued a press release with our results this morning before the market opened. The press release and accompanying slides are available on the investor relations section of our website.

Speaker Change: Additionally, we recently rolled out a new direct to consumer campaign.

Speaker Change: Pacifically speaks to the needs of parents.

Susan Smith: As Mike mentioned, competition is good for patients, particularly in a rare disease space that predominantly impacts young children. The treatment approach for each individual patient may be different. We have seen the positive impact Danielza has had on children with high-risk relapse refractory neuroblastoma in the bone and bone marrow, and believe we are only at the beginning of unlocking the potential of Danielza in our mission of improving the lives of patients and their families. A total of 65 accounts have now used Daniels around the U.S. since its initial launch in 2021, with seven new accounts added in the first six months of 2024.

Speaker Change: As Mike mentioned competition is good for patients, particularly in the rare disease space that predominantly in tax from children.

Courtney Dugan: Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined by the private securities litigation reform act of 1995. Such statements include but are not limited to statements about our business model and development. Socialization and product distribution plans. Expectations with respect to early trial data. Current and future clinical and pre-clinical studies and our research and development programs. Expectations related to the timing of the initiation and completion of regulatory submissions.

The treatment approach for each individual patient may be different we have seen the positive impact Daniels that has had on children with high risk relapsed refractory neuroblastoma in the bone in bone marrow and believe we are only at the beginning of unlocking the potential of Danielle.

Speaker Change: And our mission of improving the lives of patients and their families.

Speaker Change: A total of 65 accounts have now used daniels or around the U S. Since its initial launch in 2021 with seven new accounts added in the first six months of 2024.

Courtney Dugan: Regulatory marketing and reimbursement approvals, including statements with respect to future development of other development programs. Potential for Danielle's at territory in label expansion. A potential of an advancement of SOTA. 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 there to guidance and expectations for 2024 and beyond and our financial performance, including our estimates regarding revenues, expenses, capital expenditure requirements and other statements that are not historical facts.

Susan Smith: Danielle's total share of the U.S. anti-GD2 market is currently at approximately 17%. Physician utilization of Danielsa continues to grow. Thirty healthcare practitioners started patients on Danielsa in the first half of twenty twenty four with four physicians starting treatment on two or more patients. Since launch, a total of 108 health care providers have prescribed Danielza, and 31 of those have started treatment on two or more patients. Our dedicated U.S. commercial sales team continues to receive positive health care provider feedback on Danielza through ongoing customer interactions.

Speaker Change: Daniels is total share of the U S. Anti GTT market is currently at approximately 17%.

Speaker Change: He shouldn't utilization of Daniel's that continues to grow 30 health care practitioner started patients on Daniels that in the first half of 2024 with four physicians starting treatment on two or more patients.

Speaker Change: The launch a total of 108 health care providers have prescribed Daniels and 31 of those have started treatment on two or more patients.

Speaker Change: Our dedicated U S. Commercial sales team continues to receive positive health care provider feedback on Daniels that through ongoing customer interactions. In addition, we continue to see institutional adoption of Daniel's AR, which was added to two hospital formularies in the second quarter of 2024, bringing the total since launch to Ford.

Susan Smith: In addition, we continue to see institutional adoption of Danielza, which was added to two hospital formularies in the second quarter of 2024, bringing the total since launch to 46 hospital formularies as of June 30, 2024. Now turning to our Ex-U.S. commercial progress. We saw a boost in international orders in the second quarter versus the first quarter of this year, driven by recent launches and the continued traction our ex-U.S. distribution partners are gaining across their markets.

Courtney Dugan: Because forward-looking statements involve risks and uncertainties, they are not guarantees a 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 previously filed annual report on form 10K for the year ended December 31st, 2023. Quarterly report on form 10K for the quarter ended March 31st, 2024. And the company's quarterly report informed 10K for the quarter ended June 30th, 2024 to be filed with the SEC today.

Speaker Change: Sixth hospital formularies as of June 32024.

Speaker Change: Now turning to our ex U S commercial progress.

Speaker Change: We saw a boost in international orders in the second quarter versus the first quarter of this year driven by recent launches and the continued traction are ex U S distribution partners are gaining across their markets.

Susan Smith: This second quarter marks the first quarter of Danielle's sales in Brazil and Mexico, led by our South America partner, EDM. We expect to see additional adoption over the coming quarters and learn more about market dynamics in these regions. In Asia, our Cyclone partner continues to expand use of Danielza in China.

Speaker Change: The second quarter.

Speaker Change: Mark the first quarter of Daniels's sales in Brazil, and Mexico led by Ourself America partner IDIOM.

Mike Crossey: I would now like to turn the call over to our president and Chief Executive Officer Mike Crossey. Thank you, Courtney. Good morning, and thank you for joining us. I have with me today our Chief Commercial Officer, Susan Smith, our Chief Medical Officer, Dr. Vanessa Rajah, and our new Chief Financial Officer, Pete Frenshaw. This morning, I will begin by reviewing key financial and operational highlights from the second quarter of 2024, including Daniels of Sales Performance, and the clinical progress of our radio therapy clinical programs utilizing our self-assembly, disassembly, pre-targeted radio-immune therapy or SATA-PRIT technology plan.

Speaker Change: We expect to see additional adoption over the coming quarters and learn more about market dynamics in each regions in.

Speaker Change: In Asia, our cyclone partner continues to expand use of Daniel's in China. Additionally, we're thrilled to have received approval for Danielle, but in Hong Kong and look forward to working with our eastern Asia partner, a cyclone in anticipation of their commercial launch Daniels it in Hong Kong.

Susan Smith: Additionally, we're thrilled to have received approval for Danielza in Hong Kong, and look forward to working with our Eastern Asia partner, Cyclone, in anticipation of their commercial launch of Danielza in Hong Kong. Despite variability in orders, particularly in the U.S. during the summer months, we have continued to see an overall upward trend of sales growth since the initial launch back in 2021. We look forward to providing further updates throughout the year. I will now pass the call to Vignesh. Thank you, Sue. And hello, everyone.

Speaker Change: Despite variability in orders, particularly in the U S. During the summer months, we have continued to see an overall upward trend of sales growth since the initial launch back in 2021, we look forward to providing further updates throughout the year.

Susan Smith: Next, Sue will provide details around our global Danielle's sales in the second quarter.

Take Nash: I will now pass the call to take Nash.

Vignesh Rajah: I'm pleased to provide a brief update on our ongoing investigator-sponsored Nexidermab clinical trials. We continue to evaluate potential label expansion opportunities for Danielza in collaboration with several leading KOLs and institutions. Let me begin with an update on the multicenter investigator-sponsored trial for mexidumab in patients with second-line relapsed osteosarcoma led by Memorial Sloan Kettering Cancer Center.

Thank you Sue and Hello, everyone I'm pleased to provide a brief update on our ongoing investigator sponsored clinical.

Vignesh Rajah: The Nesh will then provide updates around our ongoing Nexidimab ISS clinical trials.

Nash: Clinical trials.

Pete Pfreundschuh: Pete will then review our second quarter of 2024 financial performance, our cash resources, and provide an update to our full year 2024 guidance before we open the line for Q&A.

Nash: We continue to evaluate potential label expansion opportunities for Daniels in collaboration with several leading kols and institutions.

Nash: Let me begin with an update on the multi center investigator sponsored trial.

Mike Crossey: Let's begin with key highlights for the second quarter of 2024 starting with Danielle's. As many of you know, neuroblastoma is the most common cancer in infants and the third most common cancer in children. Our commercial drug Danielle's is a leading anti-GD2 therapy in the US and remains critically important therapy for children with relaxed refractory high risk neuroblastoma. Danielle's is humanized and is the only FDA approved immunotherapy for high risk neuroblastoma that is specifically designed for children who have an incomplete response to induction or relaxed therapy and also have disease in the bone and or bone marrow.

Nash: <unk> in patients with second line relapsed Osteosarcoma led by Memorial Sloan Kettering Cancer Center.

Vignesh Rajah: In late June 2024, we received a preliminary draft abstract of certain results from MSK on this trial, for the 39 patients in the study with pulmonary-only recurrence. The summary stated there were 14 event-free patients at 12 months, rather than MSK's primary endpoint of 16 event-free patients at 12 months. Analysis of the full study results is still underway. Once we obtain the full data set from MSK, we plan to undertake further analysis of efficacy, including primary and secondary endpoints, evaluate tumor GD2 expression in study subjects, and the degree of correlation with clinical response.

Nash: In late June 2024, we received a preliminary draft abstract of certain results from M. S. K on this trial.

Nash: For the 39 patients in the study with pulmonary only recurrence.

Nash: Some restated the 14 event free patients at 12 months, rather than Msa's primary endpoint of 16 <unk> three patients at 12 months.

Nash: Analysis of the full study results is still underway.

Nash: Once we obtain the full data set from him SK, we plan to undertake further analysis of efficacy, including primary and secondary endpoints evaluating tumor <unk> expression in study subjects and the degree of correlation with clinical response.

Mike Crossey: Importantly, Danielle's can be administered either outpatient or inpatient depending on the specific needs of the child and his or her family. In the second quarter of 2024, we achieved total Danielle's a net product revenue of $22.8 million, up 10% from the second quarter of 2023. The increase was primarily driven by a boost in international orders from our partners wep in Western Europe and ADM in Latin America, which includes the commercial launch in Brazil and Mexico.

Vignesh Rajah: We intend to use the results of such further analysis to inform our determinations with respect to potential further development of nexidermab-based immunotherapy in patients with relapsed osteosarcoma. The complete results from this trial are expected to be presented by MSK investigators later this year at a medical meeting. In the frontline high-risk neuroblastoma setting, our partner, the BEAT Childhood Cancer Research Consortium, or BCC, is leading a multi-center phase 2 trial evaluating maxidermab in combination with standard induction therapy for patients with newly diagnosed high-risk neuroblastoma.

Nash: We intend to use the results of such further analysis to inform our determinations with respect to potential further development. Thanks, good amount based immunotherapy in patients with relapsed close to sarcoma.

Speaker Change: The complete results from this trial are expected to be presented by MSA investigators later this year at a medical meeting.

Speaker Change: In the frontline high risk neuroblastoma, setting a partner the beat childhood cancer Research consortium for BCC.

Mike Crossey: For the first six months of the year, we achieved total Danielle's a net product revenues of $42.2 million, up 3% from the same period in 2023. The increase was primarily driven by an increase in US revenues in the first half of 2024 compared to the year prior period. We are continuing to drive Danielle's a forward in our penetrating more centers. As the second quarter alone, Danielle's has been added to two new hospital formularies.

Speaker Change: Leading a multi center phase two trial evaluating <unk> in combination with standard induction therapy for patients with newly diagnosed high risk neuroblastoma.

17 sites have been opened and 10 patients have been treated to date with recruitment ongoing.

Vignesh Rajah: 17 sites have been opened and 10 patients have been treated to date with recruitment ongoing. The amended protocol for the transition to a randomized trial is currently in process and being evaluated. The BCC continues to expect the trial to transition from a single-arm trial with an exudomab added to current standard treatment for induction, to a randomized trial later this year where the control arm will be the current standard of care for induction therapy, which is chemotherapy, for which we plan to file an IND.

Speaker Change: The amended protocol for the transition to a randomized trial is currently in process and being evaluated.

Speaker Change: The BCC continues to expect the trial to transition from a single arm trial with mixed it amount added to current standard of treatment for reduction.

Mike Crossey: We saw increased market and clinical trial competition for patients in the US during the second quarter. We review this as a net positive for patients and families. As a company, we are driving investments around direct-to-parent educational efforts focused on Danielle's differentiators and bone and bone marrow. The YMAP's team has deep knowledge of the market and is specifically dedicated to pediatric neuroblastoma. XUS, we saw boost in orders in the second quarter of this year as compared to the first quarter of this year.

Speaker Change: To a randomized trial later this year, we'll have a control arm will be the current standard of care for induction therapy with just chemotherapy.

Speaker Change: For which we plan to file in R&D.

Speaker Change: Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy, and then I sit in my mom versus the standard of care.

Vignesh Rajah: Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy in the naxitamab arm versus the standard of care. In triple negative breast cancer, we're partnering with The Ohio State University on a Phase 1b slash 2 trial investigating TGF-beta NK cells, germcidabine, and mexidumab in patients with GD2-positive metastatic breast cancer. Two patients have been enrolled, and both have been treated with the initial combination of gemcitabine and NK cells.

Speaker Change: In triple negative breast cancer, we are partnering with the Ohio State University on a phase one b slash two trial investigating TGF beta NK cells.

Mike Crossey: Our partner ADM executed the Danielle's a commercial launch in both Brazil and Mexico. We are very pleased with how these launches are progressing and look forward to providing further updates in future quarters. In Asia, our cyclone partner continues to expand use of Danielle's in China. Additionally, we are thrilled to have received approval for Danielle's in Hong Kong and look forward to working with our Eastern Asia partner cyclone in anticipation of the commercial launch of Danielle's in Hong Kong.

Speaker Change: I'm, sorry to beat and exceed them up in patients with <unk> positive metastatic breast cancer.

Speaker Change: Two patients have been enrolled and both have been treated with initial combination of gemcitabine and NK cells.

Vignesh Rajah: The study is designed to evaluate safety in the first three patients treated with gencytopenia NK cells. If this combination is well tolerated, an extra amount will be added to the combination treatment for subsequent patients. We expect the first patient to be treated with the addition of Nexidermab by the end of this year. Upon the outcome of this trial, if the data supports doing so, we would consider moving forward with a multicenter Phase II trial.

The study is designed to evaluate safety in the first three patients treated with Jim's already been NK cells.

Speaker Change: This combination was well tolerated extra amount will be added to the combination treatment for subsequent patients. We expect the first patient to be treated with the addition of mix it amount by the end of this year.

Mike Crossey: Our European name patient program with web clinicals also continue to progress as we support the needs of children with high risk, relapse refractory, neuroblast, Omen, Western Europe. In addition to our new approval in Hong Kong, we entered into distribution agreement with TR Farm for our patient name program distribution of Danielle's and Turkey. We also plan to submit a BLA for Danielle's and Argentina later this year. We remain confident in our U.S, commercial strategy and trajectory and in the continued XUS expansion of Danielle's.

Speaker Change: Upon the outcome of this trial if the data supports doing so we would consider moving toward the multi center phase two trial.

Vignesh Rajah: In addition, we are in discussions with the MD Anderson Cancer Center to initiate a multicenter phase one slash two study with a phase one run-in that seeks to test the hypothesis that the addition of Nexidermab to current standard of care will increase the objective response rate in patients with metastatic triple negative breast cancer who have received at least one prior line of systemic therapy for metastatic disease. The study, which is anticipated to start in mid 2025, will further inform us on a future phase two program in triple negative breast cancer. In patients with refractory Ewing sarcoma, the Institute of Mother and Child in Poland is leading a randomized phase two trial evaluating the efficacy and safety of Nexir.

Speaker Change: In addition, we are in discussions with the MD Anderson cancer Center to initiate a multi center phase one slash two study with a phase one run in that seeks to test the hypothesis that the addition of mixing them up to current standard of care.

Speaker Change: Increase the objective response rate in patients with metastatic triple negative breast cancer, who have received at least one prior line.

Speaker Change: Caribbean for metastatic disease.

Speaker Change: The study, which is anticipated to start in mid 2025 will further inform us on a future phase II program in triple negative breast cancer.

Vignesh Rajah: The National provide updates on our investigator-sponsored trials of an exidimab later during this call.

Mike Crossey: Let me now shift to our clinical progress of our SATAPRIP programs. We are currently in part A of our GD2 SATA Phase 1 trial, evaluating the safety and tolerability of the SATAPRIP in the treatment of GD2 positive solid tumors, including small cell lung cancer, sarcomas, and malignant melanoma. As a reminder, the Phase 1 dose escalation single-arm multi-center safety study has three parts. Part A, which we are currently in, is structured to demonstrate the safety profile of the protein while it explores dose finding for the GD2 SATA molecule and testing of dose intervals of two to five days between the protein and the Lutitium-177-Dota payload.

Speaker Change: In patients with refractory Ewing sarcoma, the institute of mother and child in Poland is leading a randomized phase two trial evaluating the efficacy and safety of next year.

Speaker Change: This trial was initiated during the fourth quarter of 2023.

Vignesh Rajah: This trial was initiated during the fourth quarter of 2023. Three patients have been dosed to the Nexiribam arm to date and recruitment is ongoing. We expect a total of 16 patients in that arm. The trial is expected to be completed in 2028. We believe a significant treatment gap remains in this anti-GD2 space in both pediatric and adult cancers.

Three patients have been dosed in the next few of them today.

Speaker Change: To date and recruitment is ongoing.

Speaker Change: We expect a total of 16 patients in that at all.

Speaker Change: The trial is expected to be completed in 2020.

Speaker Change: We believe a significant treatment gap remains in design to Judy to space in both pediatric and adult cancers.

Vignesh Rajah: We're committed to supporting the advancement of these investigator-sponsored studies through clinical development and working to unlock the untapped potential of Nexirimab. Let me now hand the call over to Pete Pfreundschuh. Thank you, Vignesh. And good morning, everyone. As you heard earlier from Mike and Sue, Total Danielson Net Product Revenues of $22.8 million in the second quarter of 2024 represented a 10% increase compared to $20.8 million total Danielson Net Product Revenue in the second quarter of 2023, primarily driven by increased international revenue.

Speaker Change: We're committed to supporting the advancement of these investigator sponsored studies through clinical development and working to unlock untapped potential exit amount.

Pete friendship: Let me now hand, the call over to Pete friendship.

Mike Crossey: Part B determines the optimal dose of Lutitium-177-Dota, and Part C evaluates the initial signs of efficacy using repeat dosing. We are pleased with how the trial is progressing and have advanced through cohort 4. We are currently in cohort 5. We have dosed to a total of 17 patients to date in part A of this trial. We currently have six sites open and plan to continue adding additional sites. We are encouraged by what we've seen so far.

Pete: Thank you Big Dash and good morning, everyone as.

As you heard earlier from Mike and Sue.

Speaker Change: Total Daniels in net product revenues of $22 8 million in the second quarter of 2024, representing a 10% increase compared to $28 million total Daniels at net product revenue in the second quarter of 2023.

Speaker Change: Primarily driven by increased international revenues.

Mike Crossey: To date, no patients in the trial have experienced any dose limiting toxicity and there have been no instances of treatment related serious adverse events. Based on the spec CT scans and PK activity we have seen to date, we believe we have demonstrated proof of concept in humans that GD2 SATA can both find and bind to tumors.

Vignesh Rajah: The increase of total Danielsa Net Product Revenue, net in the quarter ended June 30th, 2024, compared to the quarter ended June 30th, 2023, was a result of the increased volume from Western Europe, as well as commercial launches for Brazil and Mexico and Latin American regions. U.S. Danielza Net Product Revenues were $15.2 million, and $15.9 million for the three months ended June 30, 2024 and 2023, respectively, representing a 4% decline.

Speaker Change: The increase of total Daniels at net product revenue.

Speaker Change: In the quarter ended June 30th 2024, compared to the quarter ended June 30th 2023.

Speaker Change: As a result of the increased volume from Western Europe, as well as commercial watches for Brazil, and Mexico, and Latin American region.

Mike Crossey: It is important to note that these early data are not complete and not necessarily indicative of full results or ultimate success of the trials or the SATA development program.

Speaker Change: U S. Daniels at net product revenues were $15 2 million.

Speaker Change: $15 9 million for the three months ended June 30th 2024, and 2023, respectively, representing a 4% decline.

Mike Crossey: We expect to complete Part A of the Phase I study by the end of this year and will to present the full data set from Part A at a medical meeting in early 2025. In the data readout from Part A of the trial, our objective is to demonstrate the safety profile of the protein and determine the optimal timing to administer the radio nuclei all of which will inform Part B. In addition, we plan to show additional scan images and PK data.

Speaker Change: Our total Daniels net.

Peter Pfreundschuh: Our total Danielsa net product revenue was $42.2 million for the six months ended June 30, 2024. An increase of 3% as compared to $41 million in the comparable period in 2023. The increase in total Daniels in net product revenue was primarily driven by a $1.2 million increase in U.S. Daniels in net product revenue in the six months ended June 30, 2024, while ex-US NET product revenue was relatively flat. We did not have licensing revenue for the three months ended June 30, 2024 and 2023.

Speaker Change: Net product revenue was $42 2 million for the six months ended June 32024.

An increase of 3% as compared to $41 million in the comparable period in 2023.

Speaker Change: The increase in total Daniels with net product revenue was primarily driven by a $1 2 million dollar increase.

Mike Crossey: Our second SATA program is CD38 SATA, which we plan to first study in the treatment of non-Hodgkin's lymphoma, focusing on B and T cell lymphoma.

Speaker Change: In U S Daniels isn't that product revenue in the six months ended June 32024.

Mike Crossey: This will be our first SATA program in circulating tumors. Our plane phase one follows a comparable design to our GD2 SATA phase one trial, which you can see here. We have selected the first six sites and expected dose the first patient in the second half of this year. We strongly believe SATA print has the potential to shift the radiotherapy treatment paradigm across a variety of cancers, and potentially even an indications beyond oncology. All while avoiding many of the infrastructure, manufacturing, and administration challenges, and many other technologies are facing.

Speaker Change: Well X U S net product revenue was relatively flat.

Speaker Change: We did not have licensing revenue for the three months ended June 30th 2024 and 2023.

Peter Pfreundschuh: We reported $.5 million of licensing revenue in the six months ended June 30, 2024, and did not have, Licensing revenue for the six months ended June 30, 2023. Moving to operating expenses, our research and development expenses were $12.3 million and $25.6 million for the quarter and six months ended June 30, 2024, which were relatively flat compared to $12.1 million and $25.5 million for the quarter and six months ended June 30, 2023. Selling general and administrative expenses increased by $5.9 million and $5.1 million, to $17.2 million and $28.7 million for the three and six months ended June 30, 2024 respectively, compared to the same periods in 2023.

Speaker Change: We reported <unk> 5 million of licensing revenue in the six months ended June 32024.

Speaker Change: And did not have.

Speaker Change: Licensing revenue for the six months ended June 30th 2023.

Speaker Change: Moving to operating expenses, our research and development expenses were $12 3 million and $25 6 million for the quarter and six months ended June 32024.

Mike Crossey: We look forward to providing further updates on our SATA programs going forward. Our team remains steadfast in our collective commitment to improve patient lives, and I'm very proud of the progress we continue to make to advance our novel therapies through clinical development.

Speaker Change: Which were relatively flat compared to $12 1 million and $25 5 million for the quarter and six men. Once ended June 30th 2023.

Susan Smith: I will now pass the call over to Susan Smith to provide further color on global denials of sales for the second quarter of 2024. Thank you, Mike, and good morning, everyone. As you heard from Mike, we're pleased with the commercial traction of denials both in the US and across our X-US markets.

Speaker Change: Selling general and administrative expenses increased by $5 9 million and $5 1 million.

Speaker Change: To $17 2 million and.

Speaker Change: And $28 7 million.

Susan Smith: As more competition arises in the form of new market entrants and clinical trials, we're continuing to sharpen our strategic commercial efforts and remain confident in the unique features and benefits denials are bringing to neuro less demo patients. In the second quarter of 2024, total worldwide denials and net product revenues were 22.8 million, a 10% increase compared to the same period last year. Primarily driven by an increase in international orders.

Speaker Change: The three and six months ended June 32024, respectively compared to the same periods in 2023.

Peter Pfreundschuh: The increase in selling general and administrative expenses for the three and six months ended June 30, 2024, were primarily attributable to a net impact of $3.8 million in charges related to two legal settlements, that were finalized in the second quarter of 2024, which is net of anticipated insurance proceeds. We reported a net loss for the quarter ended June 30, 2024, of $9.2 million, or a negative $0.21 per basic and diluted share, compared to a net loss of $6.3 million, or a negative $0.14 per basic and diluted share, for the quarter ended June 30, 2023.

Speaker Change: The increase in selling general and administrative expenses for the three and six months ended June 32024 were primarily attributable to a net impact of $3 8 million in charges related to two legal settlements.

Were finalized in the second quarter of 2024.

Speaker Change: Which is net of anticipated insurance proceeds.

Susan Smith: Breaking out US and X-US, in the US, our second quarter 2024 denials net product revenues were 15.2 million dollars, a decrease of 4% compared to the second quarter of 2023. The Q2 softness was driven by a volume decrease due to the launch of competing therapy in another class of agents and some ongoing clinical trial activity. X-US, our second quarter 2024 denials and net product revenues were 7.6 million, an increase of 55% compared to the second quarter of 2023.

We reported a net loss for the quarter ended June 32024 of $9 2 million or a negative <unk> 21 per basic and diluted share compared to a net loss of $6 3 million or a negative <unk> 14 cents per.

Speaker Change: Basic and diluted share for the quarter ended June 32023.

Peter Pfreundschuh: In addition, we have reported a net loss for the six months ended June 30, 2024 of $15.9 million or a negative $0.36 per basic and diluted share compared to a net loss of $12.7 million or a negative $0.29 per basic and diluted share for the six months ended June 30, 2023. The increase in net loss for the three and six months ended June 30, 2024, was primarily driven by the previously mentioned two legal settlements with a net $3.8 million impact. As mentioned earlier, we ended the second quarter of 2024 with cash and cash equivalent, of $77.8 million compared to $78.6 million at year-end 2023. The decrease was $0.8 million year-to-date.

Speaker Change: In addition, we have reported a net loss for the six months ended June 30th 2024.

Speaker Change: $15 9 million or a negative 36 cents per basic and diluted share compared to a net loss of $12 7 million or a negative <unk> 29 cents per basic and diluted share.

Susan Smith: In the US, our dedicated team is continuing to advance our new denials campaign aimed to reposition and elaborate on denials as differentiating characteristics in the treatment of high risk neuroblastoma for patients who are refractory or have experienced incomplete response to induction therapy in their bone and bone marrow. The critical piece of this new campaign highlights denials' performance in two different patient populations. Those patients with an incomplete response to induction therapy and patients who are relapsed after prior therapy. This campaign also highlights denials' response in children who had previously received anti-GD2 therapy.

Speaker Change: For the six months ended June 30th 2023.

Speaker Change: The increase in net loss for the three and six months ended June 30th 2024.

It was primarily driven by the previously mentioned two legal settlements with a net $3 8 million impact.

Speaker Change: As mentioned earlier, we ended the second quarter of 2024 with cash and cash equivalents of 77 8 million.

Speaker Change: <unk> to $78 6 million at year end 2023.

Susan Smith: Additionally, we recently rolled out a new direct to consumer campaign that specifically speaks to the needs of parents. As Mike mentioned, competition is good for patients, particularly in a rare disease space that predominantly impacts young children. The treatment approach for each individual patient may be different.

Speaker Change: The decrease was <unk> 8 million year to date importantly, we continue to maintain a strong balance sheet reporting.

Peter Pfreundschuh: Importantly, we continue to maintain a strong balance sheet. Reporting $2.1 million in cash inflows for the second quarter of 2024. An improvement from 5 million cash burned in the same period in 2023. Turning now to our full year 2024 guidance. We are revising our full year 2024 total net revenue to be in a range of between $87 million and $95 million from our previous guidance in the range of between $95 million to $100 million.

Speaker Change: Reporting $2 $1 million in cash inflows for the second quarter of 2024.

Speaker Change: An improvement from 5 million in cash burn in the same period in 2023.

Susan Smith: We have seen the positive impact denials that has had on children with high risk relapse refractory neuroblastoma in the bone and bone marrow, and believe we are only at the beginning of unlocking the potential of denials in our mission of improving the lives of patients and their families.

Speaker Change: Turning now to our full year 2020 for guidance.

Speaker Change: We are revising our full year 2020 for total net revenue to be in a range of between $87 million and $95 million from our previous guidance in the range of between 95 million to $100 million.

Susan Smith: A total of 65 accounts have now used Daniels are around the U.S, since its initial launch in 2021 with seven new accounts added in the first six months of 2024. Daniels' total share of the U.S, anti-GD2 market is currently at approximately 17%. There are four physicians starting treatment on two or more patients. Since launch, a total of 108 health care providers have prescribed Daniels are and 31 of those have started treatment on two or more patients. Our dedicated U.S, commercial sales team continues to receive positive health care provider feedback on Daniels are through ongoing customer interactions.

Peter Pfreundschuh: Although our current guidance is reduced for 2024, we believe that Danielza will return to higher growth rates in the second half of 2024 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. We continue to anticipate operating expenses to remain in the range of between $115 million and $120 million, which is consistent with our prior guidance.

Speaker Change: Although our current guidance is reduced for 2024, we believe that Danielle we will return to higher growth rates in the second half of 'twenty 'twenty four as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to.

Danielle: Ended indications and greater physician adoption.

Danielle: We continue to anticipate operating expenses to remain in the range of between $115 million and $120 million, which is consistent with our prior guidance.

Peter Pfreundschuh: And we expect our cash burn for the full year 2024 to remain in the range of between $15 and $20 million, which is consistent with our prior guidance. We continue to expect our cash and cash equivalent, to support our commercial operations and pipeline programs as currently planned into 2027. As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. For the purpose of this specific analysis of CACHE Runway Only. Minimal growth in Danielza Net Product Revenues is assumed to be part of the analysis.

Danielle: And we expect our cash burn for the full year 2024.

Susan Smith: In addition, we continue to see institutional adoption of Daniels, which was added to two hospital formularies in the second quarter of 2024 bringing the total since launch to 46 hospital formularies as of June 30, 2024.

Danielle: To remain in the range of between 15 and $20 million, which is consistent with our prior guidance.

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

Susan Smith: Now turning to our XUS commercial progress. We saw a boost in international orders in the second quarter versus the first quarter of this year driven by recent launches and the continued traction are XUS. Distribution partners are gaining across their markets.

Danielle: As we noted in previous quarters, the underlying assumptions for this guidance are important to understand.

Danielle: For the purpose of this specific analysis of cash runway Omi.

Susan Smith: This second quarter marked the first quarter of Daniels and sales in Brazil in Mexico led by our South America partner, EDM. We expect to see additional adoption over the coming quarters and learn more about market dynamics in these regions. In Asia, our cyclone partner continues to expand use of Daniels in China.

Speaker Change: Minimal growth in Daniels isn't that product revenues is assumed to be part of the analysis.

Speaker Change: Although we are seeing slower single digit growth for the first half of 2024 than previously anticipated and communicated.

Peter Pfreundschuh: Although we are seeing slower single-digit growth for the first half, 2024 than previously anticipated and communicated. Primarily driven by competition for patients as a result of increased clinical trial activity in the U.S. We believe Danielza will continue to grow in future periods. And this will not have a material impact on our cash flow guide. We believe that Danielza will return to higher growth rates in the second half of 2024 as we execute our refined commercial strategy and work to deliver new clinical data that potentially could lead to expanded indications and greater physician adoption. In terms of development activities, we have assumed that all of our programs will be advancing at our own expense.

Speaker Change: Primarily driven by competition for patients as a result of increased clinical trial activity in the U S. We believe Daniels it will continue to grow in future periods and this will not have a material impact on our cash flow guidance.

Susan Smith: Additionally, we're thrilled to have received approval for Daniels in Hong Kong and look forward to working with our Eastern Asia partner cyclone in anticipation of their commercial launch of Daniels in Hong Kong. Despite variability in orders, particularly in U.S, during the summer months, we have continued to see an overall upward trend of sales growth since the initial launch back in 2021.

We believe that Daniels it will return to higher growth rates in the second half of 2024, as we execute our refined commercial strategy.

Speaker Change: Work to deliver new clinical data that <unk>.

Susan Smith: We look forward to providing further updates throughout the year.

Potentially could lead to expanded indications in greater physician adoption.

Vignesh Rajah: I will now pass the call to Vignesh. Thank you, Sue.

Speaker Change: In terms of development activities, we have assumed that all of our programs, we will be advancing at our own expense.

Vignesh Rajah: Hello, everyone. I'm pleased to provide a brief update on our ongoing investigator sponsored next to map clinical trials. We continue to evaluate potential label expansion opportunities for Daniels are in collaboration with several leading KOLs and institutions.

Peter Pfreundschuh: No new programs other than the ones that are planned and in studies and trials are assumed at this point for the purposes of this analysis. With a strong balance sheet and a focused strategy, we believe Y-mAbs is well positioned to execute on our strategic mission and priorities and to support the delivery of multiple anticipated milestones, As we move ahead. This concludes the financial update, and now I will turn the call back over to Mike. Thank you for that overview, Pete. Now let's open the line for questions. Operator?

Speaker Change: No new programs other than the ones that are planned and in studies and trials are stand at this point for the purposes of this analysis.

Speaker Change: With a strong balance sheet and our focused strategy. We believe biomass is well positioned to execute on our strategic mission and priorities and to support the delivery of multiple anticipated milestones as we move ahead.

Vignesh Rajah: Let me begin with an update on the multi center investigator sponsored trial for next to map in patients with second line relapsed osteosachoma led by Memorial Sloan Kettering Cancer Center. In late June 2024, we received a preliminary draft abstract of certain results from MSK on this trial for the 39 patients in the study with pulmonary only recurrence. The summary stated there were 14 event free patients at 12 months, rather than MSK's primary end point of 16 event free patients at 12 months.

Speaker Change: This concludes the financial update and now I will turn the call back over to Mike.

Mike Rossi: Thank you for that overview Pete now.

Mike Rossi: Let's open the line for questions operator.

Speaker Change: Thank you we will now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue. We ask that analysts limit yourself to one question.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question, You may press star 2 if you would like to remove your question from the queue.

Operator: We ask that analysts limit yourself to one question and a follow-up so that others may have an opportunity to ask questions. You may requeue if you have additional questions. For participants using speaker equipment, it may be necessary to pick up your handsets before pressing the star key.

Vignesh Rajah: Analysis of the full study results is still underway. Once we obtain the full data set from MSK, we plan to undertake further analysis of efficacy, including primary and secondary end points. Evaluate tumor GD to expression in study subjects and the degree of correlation with clinical response. We intend to use the results of such further analysis to inform our determinations with the respect to potential further development of nexidimab based immunotherapy in patients with the relapse of Chiosarthoma.

Speaker Change: And a follow up because that others may have an opportunity to ask questions you.

Speaker Change: You may re queue, if you have additional questions.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the starkey.

Operator: One moment, please, while we poll for questions. Our first question comes from Etzer Darout with BMO Capital Markets. Please proceed with your question. Great. Thanks for taking the questions. First one I had was on sort of the frontline BCC study.

Speaker Change: Moment, please all we poll for questions.

Vignesh Rajah: The complete results from this trial are expected to be presented by MSK investigators later this year at a medical meeting.

Our first question comes from it's our do it with BMO capital markets. Please proceed with your question.

Vignesh Rajah: In the frontline virus neuroblastoma setting, our partner, the Beat Childhood Cancer Research Consortium, or BCC, is leading a multi-centre phase to trial evaluating nexidimab in combination with standard induction therapy for patients with newly diagnosed chyrus neuroblastoma. Seventeen sites have been opened and ten patients have been treated to date with the recruitment ongoing.

Peter Surdykowski: Oh, great. Thanks for taking the questions.

Thatcher Hubbard: First one I had was on sort of the frontline BCC study just wondered if you could talk about how.

Michael Rossi: Just wondered if you could talk about how many patients maybe you anticipate enrolling in the randomized portion of that study? And I had a follow-up on FADA. Great. Thank you, Ezra.

Speaker Change: How many patients maybe you anticipate enrolling in the randomized portion of the study and I had a follow up on China.

Speaker Change: Great. Thank you.

Michael Rossi: As far as the BCC study, I'll pass that off to Vignesh, so Vignesh can inform you a little bit more on the study. Yes. Thank you, Mike. Yes.

As far as the the BCC study I'll pass that off to the mesh.

Vignesh Rajah: The amended protocol for the transition to a randomized trial is currently in process and being evaluated. The BCC continues to expect the trial to transition from a single arm trial with nexidimab added to current standard treatment for induction to a randomized trial later this year where the control arm will be the current standard of care for induction therapy, which is chemotherapy, for which we plan to file a 9D. Our aim for the randomized trial is to demonstrate superiority in complete response at the end of induction therapy in the nexidimab arm versus the standard of care.

Speaker Change: And that's been the formula a little bit more on the on the study.

Vignesh Rajah: So, the current study, ongoing single-arm study, as Mike mentioned, enrolled 10 patients so far, and we're anticipating transitioning to a randomized study, where the design is still being evaluated. At the moment, I can't give you an exact figure of how many patients that is expected to be, but as soon as we get further details later this year, we will share that. Great.

Speaker Change: Thank you Mike Yes. So the current study ongoing single arm study is as Mike mentioned enrolled 10 patients so far and we're anticipating transitioning to a randomized study.

Speaker Change: The design is still being evaluated at the moment.

Speaker Change: I don't I can't give you an exact figure of how many patients that is expected to be but as soon as we get further details later this year, we will share that.

Speaker Change: Great. Thank you and then for the part a of of decided study just wondering if you could learn enough about <unk> two expression in the various tumor types you're exploring.

Vignesh Rajah: Thank you. And then for the Part A of the SADA study, just wondered if you could learn enough about GD2 expression and the various tumor types you're exploring to start maybe thinking about expansions into specific tumors in Part B or C, or are we still sort of too early kind of in the process to get to sort of tumor-specific evaluation, if you will, in sort of the subsequent cohorts that you'll be enrolling on Part B, C, and beyond? That's a good question.

Vignesh Rajah: In triple negative breast cancer, we are partnering with the Ohio State University on a phase 1B slash 2 trial investigating TGF beta NK cells, gem cytobine and nexidimab in patients with GD2 positive metastatic breast cancer. Two patients have been enrolled and both have been treated with initial combination of gem cytobine and NK cells.

Speaker Change: Maybe thinking about extensions into specific tumors in part B or C. O still sort of too early kind of been in the process to get to sort of tumor specific evaluation. If you will and sort of the subsequent cohorts that youll be enrolling on part D C and beyond.

Vignesh Rajah: The study is designed to evaluate safety in the first three patients treated with gem cytobine and NK cells. If this combination is well tolerated, nexidimab will be added to the combination treatment for subsequent patients. We expect the first patient to be treated with the addition of nexidimab by the end of this year.

Speaker Change: Yeah. That's a good question as we look at this we have to go with a wide basket looking at different tumor expressions and we'll collect that data I don't know that we'll have enough patients to have any sound information to focus on one or eliminate one but we will take all that into.

Michael Rossi: As we look at this, we opted to go with a wide basket, looking at different tumor expressions, and we'll collect that data. I don't know that we'll have enough patients to have any sound information to focus on one or eliminate one, but we will take all that into account as we move into Part B. Thank you. Our next question comes from Nicole Dromino with Truist Securities. Please proceed with your question. The call.

Vignesh Rajah: Upon the outcome of this trial, if the data supports doing so, we would consider moving forward the multi-center phase 2 trial.

Vignesh Rajah: In addition, we are in discussions with the MD Anderson Cancer Center to initiate a multi-center phase 1 slash 2 study with a phase 1 running that seeks to test the hypothesis that the addition of nexidimab to current standard of care will increase the objective response rate in patients with metastatic triple negative breast cancer, who have received at least one prior line of systemic therapy for metastatic disease.

Count as we move into part B.

Speaker Change: Okay. Thank you thank.

Thank you.

Okay.

Speaker Change: Our next question comes from Nicole Germs, Jimmy now with Trust Securities. Please proceed with your question.

Nicole.

Vignesh Rajah: The study which is anticipated to start in mid 2025 will further inform us on a future phase 2 program in triple negative breast cancer.

Hi, sorry about that thanks for taking the question I'm sorry.

Michael Rossi: Hi, sorry about that. Thanks for taking the question. For DD2SATA, can you walk us through the exceedance of data milestones and roughly when we can get some efficacy data from potential partners? And I have a quick follow-up. Yes, Nicole, as we look at the drug study itself, we're not designed for efficacy in Part A. So what we're looking for is really the safety of the protein and making sure that we can continue to move on to Part B where we do a dose escalation.

Nicole Germs: Can you walk us through the milestones and roughly when we could get some efficacy data on potential coffee.

Vignesh Rajah: In patients with refractory uing sarcoma, the institute of mother and child in Poland is leading a randomized phase 2 trial evaluating the efficacy and safety of nexidimab. This trial was initiated during the fourth quarter of 2023. Three patients have been doseed in the nexidimab arm to date and recruitment is ongoing. We expect a total of 16 patients in that arm. The trial is expected to be completed in 2028.

Speaker Change: I had a quick question.

Speaker Change: Yes, Nicole as we look at the drug study itself. The work we do not we're not designed for efficacy.

Speaker Change:

Speaker Change: Part a.

Speaker Change: So what we're looking for is really the safety of the protein and making sure that we can continue to move on to part B, where we do a dose escalation.

Michael Rossi: Secondary to that, we're looking for additional information coming from the protein load and the interval between the injection of the protein and the injection of the isotope. So from our Part A, as we conclude it later this year, is really focused on the safety of the protein with the additional data coming in from the interval as well as the overall protein load that we'll use to move forward in Part B. Okay, got it.

Speaker Change: Second area that we're looking for additional information coming from the protein load and the interval between the injection of the protein and the injection of the isotope so from our part a as we concluded later this year is really focused on the safety of the proteins with the additional data coming in from the <unk>.

Vignesh Rajah: We believe a significant treatment gap remains in this anti-GD2 space in both pediatric We are committed to supporting the advancement of these investigators from some studies through clinical development and working to unlock the untapped potential of next item now.

Pete Pfreundschuh: Let me now hand the call over to Pete Pfreundschuh. Thank you, Vignesh, and good morning, everyone. As you heard earlier from Mike and Sue, total Daniels in that product revenues of 22.8 million in the second quarter of 2024 represented a 10 percent increase compared to 20.8 million total Daniels in that product revenue in the second quarter of 2023, primarily driven by increased international revenues. The increase of total Daniels in that product revenue met in the quarter ended June 30, 2024 compared to the quarter ended June 30, 2023 was a result of the increased volume from Western Europe as well as commercial watches for Brazil and Mexico and Latin American regions.

Speaker Change: Interval is what would be the overall T mobile used to move forward in a heartbeat.

Okay got it.

Michael Rossi: And then just more broadly on SATA, so the SATA administration has a cold protein infusion that can be administered by the treating oncologist before the isotope infusion. While this may be a bit early, can you help us understand how reimbursement would work out for both the MedOnc and for the Radon? Yes, again, that's a good question.

Speaker Change: Then just more broadly on sort of so.

Speaker Change: The thought of administration has a quote poaching infusion that can be administered by the treating oncologist before the isotope.

Speaker Change: Well, there's maybe a bit early can you help us understand how reimbursement would work out for both of them met on the radar.

Speaker Change: Yes.

Speaker Change: Again, that's a good question. This is a novel approach and better utilizing the overall infrastructure in both oncologist offices as well as in nuclear medicine. So we know theres challenges today with having enough. There are now six weeks to do long.

Michael Rossi: This is a novel approach in better utilizing the overall infrastructure in both oncologist offices as well as in nuclear medicine. So we know there's challenges today with having enough theranostic suites to do long isotope infusions, as well as enough nuclear medicine physicians, authorized users, to be able to take the time to do that. So as we move forward going into our registration trials, we're looking at different opportunities for reimbursement and what that may look like. But that overall is not driving our strategy.

Speaker Change: I used to talk infusions as well as good.

Speaker Change: Good enough nuclear medicine physicians operate users to be able to take the time to do that so as we move forward going into a registration trials, we're looking at different opportunities for reimbursement and what that may look like but that overall, it's not driving our strategy our strategy is to.

Pete Pfreundschuh: U.S. Daniels in that product revenues were 15.2 million and 15.9 million were the three months ended June 30, 2024 and 2023 respectively representing a 4 percent decline. Our total Daniels net product revenue was 42.2 million for the six months ended June 30, 2024, an increase of 3 percent as compared to 41 million in the comparable period in 2023. The increase in total Daniels in that product revenue was primarily driven by a $1.2 million increase in U.S. Daniels in that product revenue in the six months ended June 30, 2024 while XUS net product revenue was relatively flat.

Michael Rossi: Our strategy is to be able to more effectively dose patients, to better utilize those resources from both infusion centers as well as nuclear medicine departments, and ultimately be able to treat more patients in an effective manner. Great, thank you. Thank you, Nicole. Our next question comes from Justin Walsh with Jones Trading. Please proceed with your question. All right, thanks for taking the question. Can't provide any color in your timeline, expecting...

Be able to more effectively dose patients to better utilize those resources from both infusion centers as well as nuclear medicine departments, and ultimately be able to treat more patients in an effective manner.

Speaker Change: Great. Thank you. Thank you Nicole.

Speaker Change: Our next question comes from Justin Walsh with Jones trading. Please proceed with your question.

Justin Walsh: Hi, Thanks for taking my question can you provide any color on your timeline expectations for G D to C.

Justin Walsh: Going forward do we have a sense of how long part b and C might take relative to part a.

Michael Rossi: Thank you. Relatives to... Now, as we have it laid out today, we expect to conclude Part A later this year and move right into Part B. Now, we've been increasing the speed of our recruitment in our trials, so we've been able to recruit rather quickly in Part A as we've progressed this trial. So looking at Part B, as we take the information from Part A, my expectation would be that we would be able to start treating patients in 25, early 25, with the potential to close that out in 25 or early 26.

Pete Pfreundschuh: We did not have licensing revenue for the three months ended June 30, 2024 and 2023. We reported 0.5 million of licensing revenue in the six months ended June 30, 2024 and did not have licensing revenue for the six months ended June 30, 2023. Moving to operating expenses, our research and development expenses were 12.3 million and 25.6 million for the quarter and six months ended June 30, 2024, which were relatively flat compared to 12.1 million and 25.5 million for the quarter and six months ended June 30, 2023.

Justin Walsh: Yeah.

Speaker Change: As well as we haven't laid out today, we expect to conclude part a later this year and move right into part D. Now.

Speaker Change: And then increasing the speed of our recruitment and our trials. So we've been able to recruit rather quickly in part a as we've progressed. This trial. So looking at part B as we take the information from part a my expectation would be that we would be able to start treating patients in 25 early 'twenty five.

Speaker Change: With the potential to close that out in 'twenty five or early 'twenty six dinesh anything additional in yourself.

Michael Rossi: Vignesh, anything additional on your side? Nothing to add on that. I think that is a reasonable time frame based on what we've seen so far. Obviously, it's very dependent on what results and the symmetry we see along the way, but I think that's about the best estimation we can make at this stage.

Dinesh: Nothing to add on that.

Dinesh: <unk> is a is a reasonable timeframe based on what we've seen so far.

Dinesh: Obviously, it's very it depends.

Dinesh: Dependant on what results from Dissymmetry, we see along the way, but I think that's about as best estimation, we can make at this stage.

Pete Pfreundschuh: Selling general and administrative expenses increased by 5.9 million and 5.1 million to 17.2 million and 28.7 million for the three and six months ended June 30, 2024 respectively. Compared to the same periods in 2023. The increase in selling general and administrative expenses for the three and six months ended June 30th, 2024. We're primarily attributable to a net impact of 3.8 million in charges related to two legal settlements that were finalized in the second quarter of 2024, which is net of anticipated insurance proceeds.

Great. Thanks for taking my question.

Speaker Change: Thank you.

Speaker Change: Our next question comes from Alec Stranahan with Bank of America. Please proceed with your question.

Vignesh Rajah: Thank you. Our next question comes from Alec. With Bank of America, please proceed with your question.

Michael Rossi: Hey, guys. Thanks for taking our questions. Maybe a quick follow-up on the last question that was asked. Maybe walk us through how recruitment has gone versus your expectations for the GD2 SADA studies so far, and any other unique logistical considerations you'd flag to getting these studies either for GD2 or CD38 off the ground, especially thinking as you move to Parts B and C. Thanks. Thank you, Alex. As far as recruitment goes, it was slow at first as we were getting the sites up. Now we've seen an increase in speed and recruitment in our 1001 trial for GD2. I'd expect to see that continue.

Alec Stranahan: Hey, guys. Thanks for taking the questions maybe a quick follow up on the last question that was asked.

Alec Stranahan: Maybe walk us through how recruitment has gone versus your expectations for the G. P. Tucson studies so far in.

Max: Any other unique logistical considerations you'd flag them to getting these studies either for Virginia, two or <unk> 38 up the ground I'm, especially thinking as you move to parts B and C. Max.

Pete Pfreundschuh: We reported a net loss for the quarter-ended June 30th, 2024 of 9.2 million or a negative 21 cents per basic and diluted share compared to a net loss of 6.3 million or a negative 14 cents per basic and diluted share for the quarter-ended June 30th, 2023. In addition, we have reported a net loss for the six months ended June 30th, 2024 of 15.9 million or a negative 36 cents per basic and diluted share compared to a net loss of 12.7 million or a negative 29 cents per basic and diluted share for the six months ended June 30th, 2023.

Speaker Change: Thank you Alex as far as recruitment goes it was it was slow at first as we're getting the sites up.

Judy: Now we've seen an increase in speed and recruitment and there are 10 of lung trial for Judy too.

Michael Rossi: As far as our 1201, we've recently initiated the first site with the second one right behind it. So we're actively seeking first patients for our 1201. But, you know, as we look at this, I would expect... As you dose proteins in patients for the first time, for physicians to really be judicious in who they select and how, but once you start seeing the safety data rolling in and the lack of DLTs, we see an increase overall in the speed of the trial. So I'm happy with the speed of recruitment, but again, at first in humans, you do see some lag time. Vignesh, anything additional?

Speaker Change: I would expect to see that continue as far as our 12 O. One we recently initiated the first site with the second one right behind it. So we're actively seeking first patient for our 12 O. One.

Speaker Change: But you know.

Speaker Change: As we look at this I would expect.

Speaker Change: As you dose proteins in patients for the first time for physicians to really be judicious and who they select and how.

Speaker Change: But once you start seeing the safety data rolling in and the lack of DLP, we see an increase overall in the <unk>.

Speaker Change: He is a trial so I'm happy with the speed of recruitment, but again in our first in humans you do see some some lag time Dinesh anything additional.

Pete Pfreundschuh: The increase in net loss for the three and six months ended June 30th, 2024 was primarily driven by the previously mentioned two legal settlements with a net 3.8 million impact. As mentioned earlier, we ended the second quarter of 2024 with cash and cash equivalents of 77.8 million compared to 78.6 million at year end 2023. The decrease was 0.8 million year-to-date. Importantly, we continued to maintain a strong balance sheet, reporting $2.1 million in cash inflows for the second quarter of 2024, an improvement from 5 million cash burns in the same period in 2023.

Dinesh: Yes, just to us.

Vignesh Rajah: Yeah, just to add, as you know, as Mike mentioned earlier on, this is a complex part of a phase one study where we set out to test different starter dose levels all the way from 0.3 up to much higher doses, up to 5, 10 milligrams was the original protocol, including testing dosing intervals of two to five days. So we're still in that process at the moment, so it's too soon to determine the optimal combination of permutation, but this is kind of the step-by-step process where we're taking to actually determine the optimal dose before we get down to part B. Great, makes sense. Thank you. Next question operator.

Dinesh: As you know as Mike mentioned earlier on that this is a complex part of the phase one study where we are.

Operator: As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Our next question comes from Mike Ulz with Morgan Stanley. Please proceed with your question. Hey, guys. Thanks for taking the question. Maybe just a follow-up on GD2-SADA.

Dinesh: When we set out to test different sort of dose levels. All the way from 0.3 up to a much higher doses up to $5 10 milligrams was original protocol, including testing dosing intervals of two to five days. So we're still in the process at the moment. So it's too soon to determine the optimal combination of permutation.

Dinesh: But this is kind of all the step wise process, where were taking to actually.

Dinesh: Tell me the optimal dose before we get onto puppy.

Dinesh: Great makes sense. Thank you.

Dinesh: Yeah.

Speaker Change: Next question operator.

Pete Pfreundschuh: Turning now to our full year 2024 guidance, we are revising our full year 2024 total net revenue to be in a range of between 87 million and 95 million from our previous guidance in the range of between 95 million to 100 million. Although our current guidance is reduced for 2024, we believe that Danielle will return to higher growth rates in the second half of 2024 as we execute our refined commercial strategy and work to deliver new clinical data that could potentially lead to expanded indications and greater position adoption.

Speaker Change: As a reminder, if you would like to ask a question. Please press star one on your telephone keypad. Our next question comes from Mike <unk> with Morgan Stanley. Please proceed with your question.

Mike <unk>: Hey, guys. Thanks for taking the question, maybe just a follow up on G. D. Two sada, you remind us for cohort five and part a just what dose you're at.

Michael Rossi: Can you remind us for Cohort 5 in Part A just, you know, what dose you're at, if you can? And then, are there any plans to go to a Cohort 6, for example, or dose higher? Thanks. All my good questions.

Speaker Change: If you can and then are there any plans to go to a cohort six for example or dose higher thanks.

Mike <unk>: Yeah.

Mike <unk>: Well, Mike Good question Vanessa.

Vignesh Rajah: Vignesh, you want to address the COVID-5? Yes, we're currently in Cohort 5, where we are testing one milligram per kilo at a four-day interval. Whether or not what Cohort 5 patients look like will determine how we proceed based on whether a Cohort 6 is required will really depend on the dosimetry. So, at the moment, we don't have any immediate thoughts on what that will look like. We'll wait to see what the results show in this Cohort 5. So, at the moment, it's one milligram and four-day interval. Got it.

Dress the cohort five.

Speaker Change: Yes. We're currently in cohort five are where we are testing one milligram per kilo, a four day interval whether or not.

Pete Pfreundschuh: We continue to anticipate operating expenses to remain in the range of between 115 million and 120 million which is consistent with our prior guidance. And we expect our cash burn for the full year 2024 to remain in the range of between 15 and 20 million dollars which is consistent with our prior guidance. We continue to expect our cash and cash equivalents to support our commercial operations and pipeline programs as currently planned into 2027.

Speaker Change: Cohort five patients looks like will determine how we proceed.

Speaker Change: Based on whether a cohort six is required will clearly depend on the dissymmetry. So at the moment, we don't have any immediate thoughts on what that will look like.

Speaker Change: Wait to see what the results show in this cohort five so at the moment is one milligram and four day interval.

Speaker Change: Got it thank you.

Vignesh Rajah: Thank you. Thank you. Bye.

Mike: Thank you Mike.

Mike: Our next question comes from John Newman with Canaccord Genuity. Please proceed with your question.

Operator: Our next question comes from John Newman with Canaccord Genuity. Please proceed with your question. Hi, guys. Good morning.

John Newman: Hi, guys. Good morning, Thanks, a lot for taking my question I'm, just curious with the ongoing daniels's launch obviously, you're seeing some expansion internationally, but I'm wondering if you could comment.

John Newman: Thanks a lot for taking my question. I'm just curious, with the ongoing Daniella's launch, obviously you're seeing some expansion internationally, but I'm wondering if you could comment on whether you're continuing to see the duration of therapy mature in the United States, and whether going forward that could make a. Thank you. Thank you. Thank you. Thank you, John. For Danielle's specific growth, I'll pass this to Sue.

Pete Pfreundschuh: As we noted in previous quarters, the underlying assumptions for this guidance are important to understand. For the purpose of the specific analysis of cash runway only, minimal growth in Danielle's and that product revenues is assumed to be part of the analysis. Although we are seeing slower single-digit growth for the first half of 2024 than previously anticipated and communicated, primarily driven by competition for patients as a result of increased clinical trial activity in the US, we believe Danielle will continue to grow in future periods and this will not have the material impact on our cash flow guidance.

Speaker Change: On weather.

Speaker Change: You're continuing to see the duration of therapy and mature in the United States.

Speaker Change: And whether going forward that could make a meaningful contribution to growth. Thank you.

Speaker Change: Thank you John.

Speaker Change: For Daniels of specific growth I'll pass this to sue.

Sue Smith: Great. Thank you.

Susan Smith: Great, thank you. Yeah, we have seen some duration increase, actually, with some older patients that are added, and in general, we're actually seeing more continued use as our new campaign has data showing efficacy if someone has been on a prior GD2 therapy and has not progressed well on that. When switching over to our product, we have data showing now that patients with bone or bone marrow involvement actually can get a disease response if they've been on a prior GD2 therapy. So, we're seeing an increase in uptake among physicians in that setting as well. Great, thank you.

Sue Smith: Yeah, we have seen some duration increased actually with some older patients that are added and in general and we're actually seeing more continued use him as our new campaign has data showing efficacy if someone has been on a prior G D to therapy.

Pete Pfreundschuh: We believe that Danielle's will return to higher growth rates in the second half of 2024 as we execute our refined commercial strategy and work to deliver new clinical data that potentially could lead to expanded indications and greater position adoption. In terms of development activities, we have assumed that all of our programs will be advancing at our own expense, no new programs other than the ones that are planned and its studies and trials are assumed at this point for the purposes of this analysis.

Speaker Change: And has not.

It has not progressed well on that when switching over to our product we have data showing now that ah patients with bone or bone marrow involvement actually can get a disease response, if they've been on a prior gene therapy. So we're seeing an increase in uptake among physicians.

Speaker Change: In that setting as well.

Speaker Change: Great. Thank you.

Speaker Change: Sure.

Speaker Change: Our next question comes from Justin Walsh with Jones trading. Please proceed with your question.

Operator: Our next question comes from Justin Walsh with Jones Trading. Please proceed with your question. Hi. Thanks for taking the follow-up. I�m wondering if you can remind us how you view the relative market opportunity. Dan Yeltsin.

Pete Pfreundschuh: With a strong balance sheet and the focus strategy, we believe biomass is well positioned to execute on our strategic mission and priorities and to support the delivery of multiple anticipated milestones as we move ahead.

Justin Walsh: Hi, Thanks for taking the follow up I'm wondering if you could remind us how you view the relative market opportunity for Daniels and frontline induction in high risk neuroblastoma, and osteosarcoma versus the currently approved relapsed and refractory indication.

Justin Walsh: Frontline Induction and High-Risk Neuroblastoma. And off to you, versus the currently approved RELAP. Thank you, Justin. Again, Sue.

Mike Crossey: This concludes the financial update and now I will turn the call back over to Mike. Thank you for that overview, Pete.

Speaker Change: Thank you Justin.

Speaker Change: Again too.

Operator: Now let's open the line for questions by operator. Thank you.

Speaker Change: Sure. So currently the bulk of our use is in the relapsed setting in the U S and the new campaign has done a nice job of increasing awareness of our efficacy in the refractory setting and actually the.

Susan Smith: Sure. So, currently, the bulk of our use is in the relapse setting in the U.S., and the new campaign has done a nice job of increasing awareness of our efficacy in the refractory setting. And, actually, the data that is in our new campaign does a nice job of separating this out and actually showing that a patient with an incomplete response after any treatment who has residual disease in the bone or bone marrow, this is precisely where we were studied.

Operator: We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. We ask that analyst will miss yourself to one question and a follow-up because others may have an opportunity to ask questions. You may re-queue if you have additional questions. For participants using speaker equipment, it may be necessary to pick up your handsets for pressing the star key. One moment please, will we pull for questions.

Speaker Change: Data that is in our new campaign does a nice job of separating this out and actually showing that a patient with an incomplete response after any treatment who has residual disease in the bone marrow and this is precisely where we were studying so we're starting to see and we've heard from physicians with the nuc.

Susan Smith: So, we're starting to see, and we've heard from physicians with the new campaign, that they intend to increase their use in both of those settings based on the new data. There are no further questions at this time. I would now like to turn the floor back over to Mike Rossi for closing comments. Thank you all for joining us today to discuss the progress made during the second quarter of this year. Y-mAbs is supported by a strong financial foundation, driven by the growing commercial success and geographic expansion of Danialza.

Campaign that they intend to increase their use in both of those settings based on the new data.

Justin Walsh: Our first question comes from insert to root with BMO capital markets. Please proceed with your question. Great. Thanks for taking the questions. First one I had was on sort of the front line of BCC study. Just wondered if you could talk about how many patients maybe you anticipate enrolling in the randomized portion of that study and I had a follow-up on FATA. Great. Thank you.

Speaker Change: Great. Thanks.

Speaker Change: There are no further questions at this time I would now like to turn the floor back over to Mike Rossi for closing comments.

Speaker Change: Yeah.

Michael Rossi: We believe we are uniquely positioned to continue growth while advancing the clinical development of our differentiated radioimmune therapy platform, SADA-PRIP, to 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 throughout the fall. Have a great day. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. John Newman, David Nierengarten, David Nierengarten, David Nierengarten, David Nierengarten, © BF-WATCH TV 2021, ...

Mike Rossi: Well. Thank you all for joining us today to discuss the progress made during the second quarter of this year why is supported by a strong financial foundation driven by the growing commercial success and geographic expansion of Daniels.

Vignesh Rajah: As far as the BCC study, I'll pass that off to Dinesh. So, Dinesh can inform you a little bit more in the study. Yes, thank you, Mike. Yes. So the current study, ongoing single-arm study, as Mike mentioned, enrolled 10 patients so far, and we're anticipating transitioning to a randomized study, where the design is still being evaluated at the moment. I can't give you an exact figure of how many patients that is expected to be, but as soon as we get further details, later this year, we will share that. Great, thank you.

Speaker Change: We believe we are uniquely positioned to continue growth while advancing the clinical development of our differentiated radio immunotherapy platform <unk> to 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 throughout the call have a great day.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Speaker Change: Hum.

Speaker Change: [music].

Mike Crossey: And then for the part A of the SATA study, just wondered if you could learn enough about GD2 expression in the various tumor types you're exploring to start maybe thinking about expansions into specific tumors and part B or CR is still sort of too early kind of in the process to get to sort of tumor specific evaluation, if you will, and sort of the subsequent cohort that you'll be enrolling on part BC and beyond. That's a good question.

Speaker Change: Uh huh.

Speaker Change: [music].

Mike Crossey: As we look at this, we have to go with a wide basket looking at different tumor expressions, and we'll collect that data. I don't know that we'll have enough patients to have any sound information to focus on one or eliminate one, but we will take all that into account as we move into part B. Great, thank you. Thank you.

Vignesh Rajah: Our next question comes from Nicole Dermino with true securities. Please proceed with your question. Nicole? Hi, sorry about that. Thanks for taking the question. Can you walk us through the guidance of data milestones? And roughly one, we can get some efficacy data from potential heartbeat. Yes, Nicole. As we look at the drug study itself, we're not designed for efficacy in part A. So what we're looking for is really the safety of the protein and making sure that we can continue to move on to part B where we do a dose of escalation.

Speaker Change:

Speaker Change: Yeah.

Speaker Change: [music].

Vignesh Rajah: Secondary to that, we're looking for additional information coming from the protein load and the interval between the injection of the protein and the injection of the isotope. So from our part A, as we concluded later this year, is really focused on the safety of the protein with the additional data coming in from the interval as well as the overall protein mode that we'll use to move forward in part B.

Mike Crossey: Okay, got it. And then just more broadly in SOTA. So the SOTA administration has a cool protein infusion that can be administered by the treating oncologists before the isotope infusion. And while this may be a bit early, can you help us understand how reimbursement work would worked out for both the medunk and for the radunks? Yes, again, that's a good question. This is a novel approach in better utilizing the overall infrastructure in both oncologists' offices as well as in nuclear medicine.

Mike Crossey: So we know there's challenges today with having enough thermostics weeks to do long isotope infusions as well as enough nuclear medicine physicians, authorized users to be able to take the time to do that. So as we move forward, going into our registration trials, we're looking at different opportunities for reimbursement in what that may look like. But that overall is not driving our strategy. Our strategy is to be able to more effectively dose patients, to better utilize those resources from both infusion centers as well as nuclear medicine departments, and ultimately be able to treat more patients in an effective manner.

Nicole Dermino: Thank you. Thank you, Nicole.

Vignesh Rajah: Our next question comes from Justin Walsh with Jones Trading. Please proceed with your question. Hi, thanks for taking a question. Can you provide any color on your timeline expectations for GD2SATA going forward? Do we have a sense of how long part B and C might take relative to part A? As we have laid out today, we expect to conclude part A later this year and move right into part B. Now we've been increasing the speed of our recruitment in our trials. So we've been able to recruit rather quickly in part A as we've progressed this trial.

Justin Walsh: So looking at part B as we take the information from part A, my expectation would be that we would be able to start treating patients in 25 early 25 with the potential to close that out in 25 or early 26. The next anything additional on your set? Nothing to add on matter. I think that is a reasonable timeframe based on what we've seen so far. Obviously, it's very independent on what results in the symmetry we see along the way, but I think that's as bad as best estimation we can make at this stage. Great. Thanks for taking my question. Thank you.

Speaker Change: Yeah.

Speaker Change: [music].

Alex Stranahan: Our next question comes from Alex Stranahan with Think of America. Please proceed with your question. Hey guys, thanks for taking our questions. Maybe a quick follow up on the last question I was asked. Maybe walk us through how recruitment has gone versus your expectations for the GD2SATA studies so far. And any other unique logistical considerations you'd flag to getting these studies either for G2 or CD38 off the ground, especially thinking as you move to parts B and C. Thanks.

Speaker Change:

Speaker Change: Yeah.

Alex Stranahan: Thank you, Alex. As far as recruitment goes, it was slow at first as we're getting the sights up. Now we've seen an increase in speed and recruitment and our ten or one trial for GD2. I'd expect to see that continue as far as our 1201. We recently initiated the first site with the second one right behind it. So we're actively seeking the first patient for our 1201. But, you know, as we look at this, I would expect as you go proteins and patients for the first time for physicians to really be judicious and who they select and how.

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Alex Stranahan: But once you start seeing the safety data rolling in and the lack of DLT, we see an increase overall in the speed of the trial. So I'm happy with the speed of recruitment. But, again, a first in human GDC, some like time. Do you have anything additional? Yeah, just to add, as you know, as Mike mentioned earlier on, this is a complex part of the phase one study where we set out to test different starter dose levels all the way from 0.3 up to much higher doses, up to 5, 10 milligrams or original protocol, including testing, dosing intervals or 2 to 5 days.

Alex Stranahan: So we're still in that process at the moment. So it's too soon to determine the optimal combination of permutation. But this is kind of the stepwise process where we're taking to actually determine the optimal dose before we get to part B. Great. Makes sense. Thank you. Next question, offer. As a reminder, if you would like to ask a question, please press star one on your telephone keypad.

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Vignesh Rajah: Our next question comes from Michael's with Morgan's family. Please proceed with your question. Hey guys, thanks for taking the question. Maybe just to follow up on GD2SATA, you remind us for cohort 5 in part age, you know, what dose you're at, if you can, and then are there any plans to go to a cohort 6, for example, or dose higher? Thanks. Oh my good question.

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Vignesh Rajah: Vignesh, would you address the cohort 5? Yes, we're currently in cohort 5 where we are testing 1 milligram per kilo four day interval, whether or not what cohort 5 patients look like will determine how we proceed based on whether a cohort 6 is required will really depend on the disability. So at the moment, we don't have any immediate thoughts on what that will look like, we'll wait to see what the results show in this cohort 5. So at the moment is 1 milligram and 4 day interval. Got it. Thank you.

John Newman: Our next question comes from John Newman with Category Genuity. Please proceed with your question. Hi guys, good morning. Thanks a lot for taking my question.

Susan Smith: I'm just curious with the ongoing Danielle's of launch, obviously you're seeing some expansions internationally, but I'm wondering if you could comment on whether you're continuing to see the duration of therapy mature in the United States, and whether going forward that could make a meaningful contribution to growth. Thank you. Thank you, John. For Danielle's specific growth, I'll pass this to Sue. Great, thank you. Yeah, we have seen some duration increase actually with some older patients that are added, and in general, we're actually seeing more continued use as our new campaign has data showing efficacy if someone has been on a prior GD2 therapy and has not progressed well on that.

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Susan Smith: When switching over to our product, we have data showing now that patients with bone or bone marrow involvement actually can get a disease response if they have been on a prior GD2 therapy. So we're seeing an increase in uptake among physicians in that setting as well.

John Newman: Okay, thank you.

Justin Walsh: Sure. Our next question comes from Justin Walsh, for John's trading. Please proceed with your question. Hi, thanks for taking the follow-up. I'm wondering if you can remind us how you view the relative market opportunity for Danielle's in front line induction in high-risk neuroblessedoma and osteo- Arcoma versus the currently approved Relapse and Refractory Indication. Thank you, Justin. Again, too? Sure. So, currently the bulk of our use is in the Relapse setting in the US, and the new campaign has done a nice job of increasing awareness of our efficacy in the refractory setting, and actually the data that is in our new campaign does a nice job of separating this out, and actually showing that a patient with an incomplete response after any treatment who has residual disease in the bone or bone marrow, this is precisely where we were studied.

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Justin Walsh: So, we're starting to see, and we've heard from physicians with the new campaign that they intend to increase their use in both of those settings based on the new data. Great. Thanks. There are no further questions at this time.

Mike Crossey: I would now like to turn the floor back over to Michael Ulz for closing comments. Thank you all for joining us today to discuss the progress made during the second quarter of this year. YMADS is supported by a strong financial formation driven by the growing commercial success and geographic expansion of Daniela. We believe we're a uniquely positioned to continue growth while advancing the clinical development of our differentiated radio and new therapy platform, SOTAPRIP to potentially deliver better and safer therapeutic options in the treatment of a variety of cancers.

Mike Crossey: We look forward to seeing many of you at upcoming investor and medical meetings throughout the fall. Have a great day. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. .

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Operator: John Newman, David Nierengarten, David Nierengarten, David Nierengarten, David Nierengarten,[inaudible] David Nierengarten, David Nierengarten, David Nierengarten,[inaudible] David Nierengarten, David Nierengarten, David Nierengarten,[inaudible] David Nierengarten[inaudible] . .