Core Insights - Y-mAbs Therapeutics, Inc. presented preclinical and translational pharmacokinetics data of GD2-SADA at the SNMMI Mid-Winter and ACNM Annual Meeting, highlighting its focus on cancer treatment through novel radioimmunotherapy and antibody-based products [1][2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company dedicated to developing and commercializing innovative cancer therapies, including the SADA Pretargeted Radioimmunotherapy Platform and bispecific antibodies [4] - The company’s product pipeline includes DANYELZA®, the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [4] GD2-SADA PRIT Details - GD2-SADA is a bispecific fusion protein designed for pretargeted radioimmunotherapy, binding to GD2-expressing tumors and delivering a radioactive payload for localized treatment [5] - Preclinical studies have shown robust anti-tumor efficacy of GD2-SADA with Lutetium 177 [5] Research and Development - The pharmacokinetics study characterizes GD2-SADA plasma levels in animal models and informs the design of the ongoing first-in-human Phase 1 Trial (Trial 1001) [2][3] - The research was conducted by Memorial Sloan Kettering Cancer Center, which has licensed the SADA technology to Y-mAbs [3]

Company Overview - Y-mAbs Therapeutics (NASDAQ: YMAB) has been covered with increasing optimism throughout 2024, with a "Buy" sentiment being highlighted [1] - The company operates in the biotech sector, focusing on clinical trials and innovative treatments [1] Analyst Background - The analyst holds a PhD in biochemistry and has extensive experience in analyzing clinical trials and biotech companies [1] - The analyst's mission is to educate investors on the science behind biotech investments and help them conduct due diligence [1] Disclosure and Independence - The analyst has no stock, option, or derivative positions in Y-mAbs Therapeutics or any other mentioned companies [2] - The article expresses the analyst's independent opinions and is not influenced by compensation or business relationships with the mentioned companies [2] Platform Disclaimer - Seeking Alpha emphasizes that past performance does not guarantee future results and does not provide specific investment recommendations [3] - The platform's analysts are third-party authors, including both professional and individual investors, who may not be licensed or certified by regulatory bodies [3]

Financial Performance - Y-mAbs Therapeutics reported preliminary estimated unaudited total net revenue of approximately $88 million for the year ended December 31, 2024, within the guidance range of $87 million to $95 million[4]. - The company expects operating expenses for the year ended December 31, 2024, to be between $115 million and $120 million[4]. - Preliminary estimated cash and cash equivalents as of December 31, 2024, are approximately $67 million, with a total annual cash investment of about $11 million, below the guidance range of $15 million to $20 million[4]. Workforce and Restructuring - The company plans to reduce its workforce by up to approximately 13% as part of a business realignment plan[9]. - Restructuring expenses related to the workforce reduction are expected to be up to approximately $2.6 million, primarily for severance payments and stock-based compensation[10][11]. - The company anticipates the restructuring expenses will impact results during Q4 2024 and Q1 2025, with cash payments occurring through the first half of 2026[11]. Business Strategy - The business realignment will focus on two units: one for expanding market access to DANYELZA and another for advancing the radiopharmaceutical platform[8]. - The business realignment aims to increase operational flexibility and speed, and accelerate clinical development within the radiopharmaceutical platform[8]. - The company appointed Doug Gentilcore as SVP, Danyelza Business Unit Head, and promoted Natalie Tucker to SVP, Radiopharmaceutical Business Head[13]. Cautionary Statements - The company cautions that actual results may differ materially from preliminary estimates due to various factors, including completion of year-end closing procedures[16].

Core Insights - Y-mAbs Therapeutics, Inc. has established two business units focused on Radiopharmaceuticals and DANYELZA to enhance clinical development and commercial potential [3][4][5] - Preliminary data from the GD2-SADA Phase 1 trial indicates the tolerability and validity of the SADA PRIT platform, with data presentation expected in Q2 2025 [8][9] - The company reported an estimated unaudited total net revenue of approximately $88 million for FY 2024, aligning with its guidance range [10] - As of December 31, 2024, the company has approximately $67 million in cash and marketable securities, expected to support operations until 2027 [10] Business Update - The company is realigning operations by creating two business units: Radiopharmaceuticals and DANYELZA, aimed at optimizing resources and enhancing clinical execution [3][4] - The realignment is expected to improve capital efficiencies and align strategic priorities [5] Radiopharmaceuticals - The SADA PRIT platform aims to enhance traditional radioimmunotherapy by delivering high therapeutic doses while minimizing off-target exposure [6] - The platform is currently being evaluated in two clinical trials in the U.S. [6] DANYELZA - DANYELZA is the only FDA-approved treatment for high-risk relapsed/refractory neuroblastoma in patients aged one year and older, launched commercially in 2021 [6] Workforce Adjustment - The company anticipates a workforce reduction of up to approximately 13%, with some roles being relocated from Denmark to the U.S. [7] Pipeline Advancement - In the GD2-SADA Phase 1 trial, 21 patients have been dosed, showing no dose-limiting toxicities or treatment-related adverse events [8][9] - The company plans to dose the first patient in the CD38-SADA Phase 1 trial in Q1 2025 [9] Financial Results - Preliminary estimated unaudited total net revenue for FY 2024 is approximately $88 million, within the guidance range of $87 million to $95 million [10] - The estimated cash investment for FY 2024 is approximately $11 million, below the guidance range of $15 million to $20 million [10] Upcoming Events - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [12]

Core Insights - Y-mAbs Therapeutics, Inc. has announced the establishment of two business units aimed at accelerating the clinical development of its Radiopharmaceuticals Platform and optimizing the commercial potential of DANYELZA [2][3][4] - Preliminary data from the GD2-SADA Phase 1 trial indicates the tolerability and validity of the SADA PRIT platform's pre-targeting approach, with data presentation expected in Q2 2025 [8][9] - The company reported preliminary estimated unaudited total net revenue of approximately $88 million for the year ended December 31, 2024, aligning with its guidance range [10] - As of December 31, 2024, the company has approximately $67 million in cash, cash equivalents, and marketable securities, which is expected to support operations into 2027 [10] Business Update - The company is realigning operations by creating two business units: Radiopharmaceuticals and DANYELZA, to enhance resource optimization and clinical development agility [3][4] - The realignment is expected to lead to a workforce reduction of up to approximately 13%, with some roles being moved from Denmark to the U.S. for better coordination [7] Radiopharmaceuticals - The SADA PRIT platform aims to improve traditional radioimmunotherapy by delivering high therapeutic doses while minimizing off-target exposure and reducing costs [6] - The platform is currently being evaluated in two clinical trials in the U.S. [6] DANYELZA - DANYELZA is the only FDA-approved treatment for patients aged one year and older with high-risk relapsed/refractory neuroblastoma, commercially launched in 2021 [6] Pipeline Advancement - In the GD2-SADA Phase 1 trial, 21 patients have been dosed, showing no dose-limiting toxicities or treatment-related adverse events [8][9] - The company anticipates dosing the first patient in the CD38-SADA Phase 1 trial in the first quarter of 2025 [9] Financial Overview - Preliminary estimated total cash investment for FY 2024 is approximately $11 million, below the guidance range of $15 million to $20 million [10] - The company plans to provide full-year 2025 guidance alongside the FY 2024 earnings report in Q1 2025 [13] Upcoming Events - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [12]

Company Leadership Changes - Sue Smith, Chief Commercial Officer, will be departing the organization [1] - Doug Gentilcore appointed as Senior Vice President, Head of DANYELZA Business Unit [4] - Doug Gentilcore brings over two decades of strategic leadership experience in the pharmaceutical industry [5] Product Information - DANYELZA® (naxitamab-gqgk) is indicated for the treatment of pediatric and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow [1] - DANYELZA® includes a Boxed Warning for serious infusion-related reactions and neurotoxicity [1] - DANYELZA is currently not approved for the treatment of osteosarcoma in any jurisdiction [2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic cancer products [3] - The Company's technologies include its investigational SADA PRIT Platform and bispecific antibodies generated using the Y-BiClone platform [3] - The Company's product pipeline includes the anti-GD2 therapy DANYELZA® [3] Future Plans and Expectations - Doug Gentilcore's experience is expected to be instrumental in the continued commercial expansion and growth of DANYELZA beyond pediatric oncology [5]

Core Insights - Y-mAbs Therapeutics, Inc. has established two business units focused on Radiopharmaceuticals and DANYELZA to enhance operational efficiency and commercial growth [2][3][4] - The company reported preliminary estimated unaudited total net revenue of approximately $88 million for the year ended December 31, 2024, aligning with its guidance range [9] - Y-mAbs anticipates a reduction in its workforce by up to 13% as part of its business realignment strategy [6] Business Update - The establishment of the two business units aims to optimize internal resources and enhance the advancement of the SADA PRIT platform while driving the commercial growth of DANYELZA [2][3] - The SADA PRIT platform is designed to improve traditional radioimmunotherapy by delivering high therapeutic doses with minimized off-target exposure [5] - DANYELZA is the only FDA-approved treatment for high-risk relapsed/refractory neuroblastoma in patients aged one year and older, launched commercially in 2021 [5] Pipeline Advancement - The GD2-SADA Phase 1 trial has dosed 21 patients, showing a well-tolerated pre-targeting approach with no dose-limiting toxicities reported [7][8] - The company expects to present data from Part A of the GD2-SADA Phase 1 trial in the second quarter of 2025 [12] - The first patient in the CD38-SADA Phase 1 trial is expected to be dosed in the first quarter of 2025 [8][12] Financial Overview - Preliminary estimated unaudited cash, cash equivalents, and marketable securities as of December 31, 2024, are approximately $67 million, expected to support operations into 2027 [9] - The total cash investment for the full year 2024 is estimated at approximately $11 million, below the company's guidance range [9] Upcoming Events - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [11] - Full year 2025 guidance is expected to be provided alongside the full year 2024 earnings report in the first quarter of 2025 [12]

Core Points - Y-mAbs Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [3] - Michael Rossi, the President and CEO of Y-mAbs, will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025 [1] - A live webcast of the presentation will be available on the company's investor relations website and archived for 30 days [2] Company Overview - Y-mAbs utilizes advanced technologies such as the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies generated through the Y-BiClone platform [3] - The company's product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in patients who have had a partial response, minor response, or stable disease to prior therapy [3]

Financial Data and Key Metrics Changes - Total net revenue for Q3 2024 was $18.5 million, down 10% from the same period in 2023, primarily due to a decline in net product revenues in both the U.S. and ex-U.S. markets [11][41] - U.S. DANYELZA net product revenues were $15.3 million, representing a 5% decrease compared to Q3 2023, attributed to a change in estimate from Medicaid claims [27][42] - Ex-U.S. DANYELZA net product revenues were $3.1 million, a 19% decline compared to Q3 2023, driven by decreased volume from the WEP patient access program in Europe [30][43] - The company reported a net loss of $7 million for Q3 2024, compared to a net loss of $7.7 million for Q3 2023 [47] - Cash and cash equivalents at the end of Q3 2024 were $68.1 million, down from $78.6 million at year-end 2023 [49] Business Line Data and Key Metrics Changes - DANYELZA sales performance showed a 5% increase in demand compared to Q2 2024, indicating growing physician adoption [9] - The company added three new U.S. DANYELZA accounts in Q3 2024, bringing the total to 68 accounts since launch [28] - DANYELZA's estimated total share of the U.S. anti-GD2 market remained steady at approximately 15% as of September 30, 2024 [28] Market Data and Key Metrics Changes - The third quarter marked the first recorded sales of DANYELZA in Turkey and continued sales in Brazil and Mexico [31] - In Asia, the partner SciClone is expanding the use of DANYELZA in China and preparing for a launch in Hong Kong [32] Company Strategy and Development Direction - The company is focused on expanding DANYELZA's market presence and has entered into a licensing agreement with Nobelpharma for DANYELZA in Japan, with potential milestone payments of up to $31 million [13] - The company plans to submit a regulatory filing for marketing approval of DANYELZA in Argentina later this year [15] - The SADA PRIT technology platform is being developed to address treatment gaps in various cancers, with ongoing clinical trials [23] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from competition affecting DANYELZA but expressed confidence in the long-term growth trajectory [8][33] - The company reiterated its full-year 2024 total net revenue guidance to be in the range of $87 million to $95 million, expecting to land in the lower half of that range [50] Other Important Information - The company received notification of an accepted patent extension for DANYELZA, extending the U.S. patent expiration to February 5, 2034 [12] - The company is in the process of evaluating multiple targets for future SADA programs, with updates expected in early 2025 [87] Q&A Session Summary Question: Can you discuss the price mix dynamic for DANYELZA and its future expectations? - Management noted a $1.5 million charge in Q3 related to Medicaid claims, which contributed to a 5% decline in net revenues despite a 5% increase in vials sold [54] Question: What are the key criteria for dose selection in the GD2 SADA study? - Management indicated that the optimal protein dose is being refined based on preclinical pharmacokinetic data, focusing on a dose of 1 milligram per kilogram [55] Question: What are the swing factors for Q4 revenues? - Management expressed confidence in landing within the revenue guidance range, citing adjustments related to sales timing and Medicaid claims [60] Question: How does the company view the competitive landscape for pre-targeting approaches? - Management welcomed the entry of more companies into the pre-targeting space, viewing it as validation for their approach and an opportunity to enhance patient treatment logistics [68] Question: Can you elaborate on the dose-escalation decisions for SADA? - Management clarified that the adjustments in dosing were based on pharmacokinetic modeling rather than tumor type differences, aiming to optimize the balance between tumor targeting and clearance [90]

Core Viewpoint - Y-mAbs Therapeutics, Inc. reported a quarterly loss of $0.16 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.14, indicating a negative earnings surprise of -14.29% [1] Financial Performance - The company posted revenues of $18.46 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 21.03% and down from $20.45 million a year ago [2] - Over the last four quarters, Y-mAbs has surpassed consensus EPS estimates only once [2] Stock Performance - Y-mAbs shares have increased approximately 128% since the beginning of the year, significantly outperforming the S&P 500's gain of 25.2% [3] Future Outlook - The company's earnings outlook will be crucial for assessing future stock performance, particularly in light of management's commentary during the earnings call [4] - Current consensus EPS estimate for the upcoming quarter is -$0.12 on revenues of $25.71 million, and for the current fiscal year, it is -$0.62 on revenues of $92.76 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Y-mAbs belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable industry outlook [8]