Core Insights - Y-mAbs Therapeutics, Inc. is focused on developing and commercializing novel radiopharmaceuticals and antibody-based therapeutic products for cancer treatment, with a virtual R&D update scheduled to highlight progress in its Radiopharmaceutical Business Unit [1][2] Radiopharmaceutical R&D Update Highlights - The GD2-SADA Phase 1 Clinical Trial (Trial 1001) has completed Part A, demonstrating that GD2-SADA is safe, tolerable, and capable of achieving targeted in vivo conjugation of Lu-DOTA [3][4] - The company plans to initiate a Trial 1001 Bridge study (Part 2A) with an optimized Radiohapten, "Proteus," in the first half of 2026, with data readout expected in the second half of 2026 [3][12] - Part B of Trial 1001 is anticipated to start in the first half of 2027, with data readout expected in the second half of 2027 [3][12] Clinical Trial Details - The primary objective of Trial 1001 is to evaluate the safety and tolerability of GD2-SADA in patients with recurrent or refractory metastatic solid tumors, including small cell lung cancer and high-risk neuroblastoma [4] - In Part A, 22 patients were dosed, with nine patients showing positive GD2 expression and eligible for the therapeutic stage of the study [4] - Results indicated that the GD2-SADA Protein clearance rate is reliably correlated to dose concentrations, providing a roadmap for tailoring the clearance interval prior to isotope administration [4][5] Safety and Tolerability - Both GD2-SADA and Lu-DOTA administrations were generally safe and well-tolerated, with no treatment-related serious adverse events reported [5] Expanded Development Pipeline - Y-mAbs has selected lung cancer, women's cancers, and gastrointestinal cancers as target areas for its expanded oncology franchise [7] - The company plans to file an IND for its first molecular imaging asset by the end of 2025 [7] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company with a focus on novel radioimmunotherapy and antibody-based therapeutic cancer products, including the FDA-approved anti-GD2 therapy DANYELZA [9]

Core Insights - Y-mAbs Therapeutics, Inc. is focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [1][4] - The company presented data on GD2-SADA in a trial for recurrent or refractory metastatic solid tumors expressing GD2 at the Advances in Neuroblastoma Research Meeting [1][2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company with a focus on radioimmunotherapy and antibody-based cancer therapies [4] - The company’s product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [4] Trial Information - The ongoing Phase 1 trial (Trial 1001, NCT05130255) evaluates the safety and tolerability of GD2-SADA Pretargeted Radioimmunotherapy (GD2-SADA PRIT) with Lutetium 177 DOTA (177Lu-DOTA) in patients with GD2-expressing solid tumors [2][5] - Part A of the trial focuses on dose escalation to determine the optimal safe dose of GD2-SADA and the administration interval between GD2-SADA and 177Lu-DOTA [2] Presentation Details - The trial data was presented in a poster format at the Advances in Neuroblastoma Research Meeting on May 26, 2025 [3] - The initial data readout from Trial 1001 is expected to be provided during a virtual Radiopharmaceutical R&D update on May 28, 2025 [3] Technology Overview - GD2-SADA is a bispecific fusion protein designed to bind to GD2 and Lutetium 177 DOTA, facilitating targeted radiotherapy [5] - The pre-targeted radiotherapy process involves an initial infusion of non-radiolabeled GD2-SADA followed by a second infusion delivering the radioactive payload for localized irradiation [5] Research Collaboration - The SADA technology for radioimmunotherapy was developed by researchers at Memorial Sloan Kettering Cancer Center and is exclusively licensed to Y-mAbs [6]

Financial Data and Key Metrics Changes - The company reported net product revenues of $20.9 million for the first quarter of 2025, an 8% increase from $19.4 million in the same period last year [21][24] - The net loss for the quarter was $5.2 million, or a negative $0.12 per share, compared to a net loss of $6.6 million, or a negative $0.15 per share, in Q1 2024 [24][26] - Cash and cash equivalents at the end of Q1 2025 were $60.3 million, down from $67.2 million at the end of 2024 [25][26] Business Line Data and Key Metrics Changes - The Danielza business unit achieved net product revenues of $20.9 million, with U.S. revenues at $13.4 million, down 28% year-over-year, while ex-U.S. revenues were $7.5 million, an increase of $6.7 million [17][21] - The segment profit margin for the Danielza business unit was 42% in Q1 2025, compared to 44% in Q1 2024 [25] - The radiopharmaceuticals business unit reported a segment loss of $6.1 million for Q1 2025, slightly higher than the $6.0 million loss in Q1 2024 [25] Market Data and Key Metrics Changes - The company noted a slowdown in new patient enrollment in the U.S. due to competitive pressures and market dynamics, impacting revenue [18][19] - The addition of Danielza to the NCCN guidelines is expected to enhance its market position and clinician adoption [19][100] Company Strategy and Development Direction - The company has realigned its business into two distinct units: Danielza and Radiopharmaceuticals, aiming to maximize the potential of each [9][25] - Upcoming events include a virtual radiopharmaceutical R&D event on May 28, where key updates on clinical trials and pipeline developments will be shared [11][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and ability to fund operations into 2027, despite current challenges [10][26] - The company anticipates a realistic revenue guidance for Q2 2025 between $17 million and $19 million, factoring in seasonality and historical trends [26][40] Other Important Information - The company is monitoring potential tariff impacts on its supply chain, expecting minimal effects at this time [27] - The company continues to focus on advocacy development and expanding its market reach for Danielza [75][100] Q&A Session Summary Question: Dynamics of U.S. and ex-U.S. revenue for Danielza - Management noted steady growth outside the U.S. and a slower start in the U.S. due to competitive pressures, but an uptick in enrollments is expected [30][32] Question: Q2 revenue guidance and historical trends - Management acknowledged seasonality and historical stock-in dynamics affecting Q2 guidance, projecting slight growth in U.S. sales [38][40] Question: Plans for naxitamab in osteosarcoma - The company is supporting ongoing studies and looking to improve diagnostics for GD2 expression [47][48] Question: Medicaid reserve adjustments - Management indicated stabilization in Medicaid gross-to-net elements, with no major changes anticipated for 2025 [59][62] Question: Impact of new linker on CD38 study - The current CD38 study will maintain its construct while safety data is established before any changes are made [65][84] Question: Stabilization in cycles per patient for Danielza - Management reported consistent volumes per facility, focusing on penetrating larger accounts rather than just the number of vials per patient [89][90] Question: NCCN guidelines impact on Danielza growth - Inclusion in the NCCN guidelines is expected to remove previous headwinds and provide opportunities for increased clinician discussions [99][100]

Financial Data and Key Metrics Changes - The company recorded total Danielza net product revenues of $20.9 million in Q1 2025, representing an 8% increase from $19.4 million in Q1 2024 [20][24] - The net loss for Q1 2025 was $5.2 million, or a negative $0.12 per share, compared to a net loss of $6.6 million, or a negative $0.15 per share in Q1 2024 [23][24] - Cash and cash equivalents at the end of Q1 2025 were $60.3 million, down from $67.2 million at the end of 2024, indicating an investment of $6.9 million in Q1 2025 [24][26] Business Line Data and Key Metrics Changes - Danielza's net product revenues in the U.S. for Q1 2025 were $13.4 million, down 28% from the prior year, while ex-U.S. revenues were $7.5 million, an increase of $6.7 million, driven by the named patient program in Western Asia [15][20] - The Danielza business unit achieved a segment profit from operations of $8.8 million, reflecting a 42% segment profit margin based on total revenues [24] - The radiopharmaceuticals business unit reported a segment loss from operations of $6.1 million for Q1 2025, compared to a loss of $6.0 million in Q1 2024 [24] Market Data and Key Metrics Changes - The company noted a slowdown in new patient enrollment in the U.S. due to competitive pressures and market dynamics, impacting revenue [16][18] - The addition of Danielza to the NCCN guidelines for treating relapsed or refractory neuroblastoma is expected to enhance its market position and drive future growth [18][100] Company Strategy and Development Direction - The company has established two distinct internal business units, Danielza and Radiopharmaceuticals, to maximize potential and accelerate development [6][24] - The focus is on enhancing advocacy, increasing new patient starts, and expanding into high-volume commercial accounts to improve Danielza's market share [12][71] - Upcoming updates on the radiopharmaceutical R&D event are scheduled for May 28, which will include data from clinical trials and pipeline updates [9][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and ability to fund operations into 2027, despite current challenges [7][25] - The anticipated revenue guidance for Q2 2025 is between $17 million and $19 million, reflecting seasonal trends and historical performance [25][40] - Management remains optimistic about the potential for growth in the U.S. market, particularly with the recent inclusion of Danielza in treatment guidelines [100][102] Other Important Information - The company is monitoring potential tariff impacts on its supply chain, with expectations of minimal effects [26] - Research and development expenses decreased to $11.4 million in Q1 2025 from $13.3 million in Q1 2024, reflecting prudent spending [22][23] Q&A Session Summary Question: Understanding U.S. and ex-U.S. revenue dynamics for Danielza - Management noted steady growth outside the U.S. and a slower start in the U.S. due to competitive pressures, but an uptick in enrollments is expected [30][32] Question: Q2 revenue guidance and historical trends - Management explained that seasonality and previous stock ins influenced the guidance, projecting slight growth in U.S. sales [38][40] Question: Plans for naxitamab in osteosarcoma - The company continues to support research in osteosarcoma and aims to improve diagnostics for GD2 expression [46][47] Question: Details on CD38 SADA trial - The first patient has been dosed, with plans to enroll 12 to 15 patients in a safety study [50][52] Question: Medicaid reserve perspective - Management indicated stabilization in Medicaid gross to net elements, with no major adjustments anticipated for 2025 [55][58] Question: Impact of new construct for GD2 SADA on study timelines - A bridging study will be conducted to assess safety before moving forward with Part B of the study [61][62] Question: Long-term growth for Danielza - The focus is on advocacy development, financial messaging, and global expansion to drive long-term growth [71][72] Question: NCCN guidelines impact on Danielza growth - Inclusion in the guidelines is expected to remove a headwind and provide potential tailwinds for market discussions [99][100]

Company Performance - Y-mAbs Therapeutics, Inc. reported a quarterly loss of $0.12 per share, better than the Zacks Consensus Estimate of a loss of $0.22, and an improvement from a loss of $0.15 per share a year ago, representing an earnings surprise of 45.45% [1] - The company posted revenues of $20.9 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 6.92%, compared to year-ago revenues of $19.93 million [2] - Over the last four quarters, Y-mAbs has surpassed consensus EPS estimates just once and topped consensus revenue estimates only once [2] Stock Performance - Y-mAbs Therapeutics shares have declined approximately 48% since the beginning of the year, contrasting with the S&P 500's decline of only 0.6% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.26 on revenues of $20.05 million, and for the current fiscal year, it is -$1.02 on revenues of $82.79 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Y-mAbs belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry performance can significantly impact stock performance [5][8]

Financial Performance - Net product revenue for Q1 2025 was $20.904 million, an increase of 7.6% compared to $19.431 million in Q1 2024[21]. - Total revenues for Q1 2025 were $20.904 million, compared to $19.931 million in Q1 2024, reflecting a growth of 4.9%[21]. - Gross profit for Q1 2025 was $17.903 million, slightly up from $17.834 million in Q1 2024[21]. - The net loss for Q1 2025 was $5.196 million, compared to a net loss of $6.629 million in Q1 2024, showing an improvement of 21.6%[21]. - For the three months ended March 31, 2025, the net loss was $5,196,000, a decrease of 21.5% compared to a net loss of $6,629,000 for the same period in 2024[25]. - The Company reported a net loss of $5,196,000 for the three months ended March 31, 2025, an improvement from a net loss of $6,629,000 in the same period of 2024[55]. - Basic and diluted net loss per share improved to $(0.12) in Q1 2025 from $(0.15) in Q1 2024[55]. - Total revenues for the three months ended March 31, 2025, were $20,904,000, an increase from $19,931,000 in the same period of 2024, representing a growth of approximately 4.9%[104]. Expenses - Research and development expenses decreased to $11.359 million in Q1 2025 from $13.267 million in Q1 2024, a reduction of 14.4%[21]. - Selling, general, and administrative expenses increased to $13.087 million in Q1 2025 from $11.425 million in Q1 2024, an increase of 14.5%[21]. - Stock-based compensation for the three months ended March 31, 2025, was $3,341,000, a decrease of 13.1% from $3,846,000 in the same period of 2024[25]. - The cost of goods sold for the three months ended March 31, 2025, was $3,001,000, compared to $2,097,000 for the same period in 2024, indicating an increase of approximately 43.1%[104]. - Research and development expenses for the DANYELZA segment were $4,926,000 for the three months ended March 31, 2025, down from $5,409,000 in 2024, reflecting a decrease of approximately 8.9%[106]. Assets and Liabilities - Total assets as of March 31, 2025, were $112.613 million, down from $119.904 million as of December 31, 2024[19]. - Total liabilities decreased to $23.156 million as of March 31, 2025, from $27.900 million as of December 31, 2024[19]. - The accumulated deficit increased to $492.332 million as of March 31, 2025, from $487.136 million as of December 31, 2024[19]. - Cash and cash equivalents decreased to $60,310,000 as of March 31, 2025, down from $67,234,000 at the end of 2024, representing a decline of 10.5%[32]. - Accrued liabilities decreased to $13,875,000 as of March 31, 2025, down from $16,406,000 as of December 31, 2024, a reduction of 15.5%[59]. Cash Flow - The net cash used in operating activities was $6,911,000 for Q1 2025, compared to $3,477,000 for Q1 2024, indicating an increase of 98.5%[25]. - The company has experienced negative cash flows from operations since inception, highlighting ongoing financial challenges[29]. - The company expects its cash and cash equivalents to be sufficient to fund operations for at least the next 12 months from the issuance date of the financial statements[32]. Business Operations - The company operates two business units: DANYELZA and Radioimmunotherapy (RIT), following a business realignment strategy announced in January 2025[47]. - The company has funded operations primarily through proceeds from sales of common stock and sales of DANYELZA, along with a Priority Review Voucher obtained upon FDA approval[31]. - The company may seek additional capital through various means, including the sale of securities and collaboration agreements[33]. - The company has adopted a business realignment plan aimed at optimizing operations, which may result in a workforce reduction of up to 13%[107]. Stock and Equity - The company’s stockholders authorized a total of 105,500,000 shares, with 45,250,794 shares of common stock issued as of March 31, 2025[81][82]. - The company has 2,696,825 shares available for grant under the 2018 Equity Incentive Plan as of March 31, 2025[86]. - The company granted 490,396 restricted stock units (RSUs) during the three months ended March 31, 2025, with a weighted average grant price of $6.15[90]. - The total fair value of RSUs vested during the three months ended March 31, 2025, was $1,262,000, compared to $525,000 for the same period in 2024, reflecting an increase of approximately 140.4%[90]. - The company granted 1,255,699 stock options during the three months ended March 31, 2025, with a weighted average exercise price of $6.10[93]. - The total intrinsic value of stock options exercised during the three months ended March 31, 2025, was $199,000, compared to $924,000 in 2024, showing a decrease of approximately 78.5%[94]. Lease and Facilities - The company entered into a lease agreement for new office space in Princeton, New Jersey, with a fixed rent starting at approximately $362,000 in the first year after a nine-month rent-free period[73]. - The company’s weighted average remaining lease term as of March 31, 2025, was 1.28 years, with a weighted average discount rate of 8.4% used to determine operating lease liabilities[78]. - Total operating lease liabilities as of March 31, 2025, were $603,000, a decrease from $820,000 as of December 31, 2024, representing a reduction of approximately 26.5%[78]. - Cash paid for lease liabilities was $244,000 for the three months ended March 31, 2025, down from $251,000 in the same period of 2024[78]. - The company reported total operating lease expenses of $243,000 for the three months ended March 31, 2025, compared to $246,000 for the same period in 2024, reflecting a decrease of approximately 1%[77]. Regulatory and Market Challenges - The company expects to continue facing challenges in the commercialization of DANYELZA and other product candidates due to market acceptance and regulatory hurdles[9].

Revenue Performance - Reported net product revenues of $20.9 million for Q1 2025, an 8% increase from $19.4 million in Q1 2024[5] - U.S. DANYELZA net product revenues decreased by 28% to $13.4 million in Q1 2025, driven by clinical study enrollments and market dynamics[10] - Ex-U.S. DANYELZA net product revenues increased by $6.7 million to $7.5 million in Q1 2025, supported by new marketing initiatives in Western and Eastern Asia[11] - Total revenues for Q1 2025 were $20,904,000, an increase of 7.3% compared to $19,931,000 in Q1 2024[34] Financial Guidance - Management reiterates full year 2025 guidance with total revenues expected between $75 million and $90 million[25] - Second quarter 2025 total revenue guidance is projected to be between $17 million and $19 million[22] Expenses - Research and development expenses decreased to $11.4 million in Q1 2025 from $13.3 million in Q1 2024, primarily due to timing of clinical trials[17] - Selling, general, and administrative expenses increased to $13.1 million in Q1 2025 from $11.4 million in Q1 2024, attributed to higher personnel costs and business realignment expenses[18] - Total operating costs and expenses for Q1 2025 were $24,446,000, slightly down from $24,742,000 in Q1 2024, a decrease of 1.2%[34] - Research and development expenses for Q1 2025 were $11,359,000, a decrease of 14.4% compared to $13,267,000 in Q1 2024[34] - Selling, general, and administrative expenses increased to $13,087,000 in Q1 2025, up from $11,425,000 in Q1 2024, an increase of 14.5%[34] Profitability - The company reported a net loss of $5.2 million for Q1 2025, an improvement from a net loss of $6.6 million in Q1 2024[20] - Net loss for Q1 2025 was $5,196,000, a decrease from a net loss of $6,629,000 in Q1 2024, representing a 21.6% improvement[34] - Gross profit remained consistent at $17.9 million for Q1 2025, with gross margins decreasing to 86% from 89% in Q1 2024[16] - The company reported a gross profit of $17,903,000 for Q1 2025, compared to $17,834,000 in Q1 2024, reflecting a slight increase[34] Cash Position - Cash and cash equivalents as of March 31, 2025, were $60.3 million, with anticipated revenues expected to support operations into 2027[21] - Cash and cash equivalents decreased to $60,310,000 as of March 31, 2025, down from $67,234,000 at the end of 2024, a decline of 10.4%[32] Asset Management - The total assets decreased to $112,613,000 as of March 31, 2025, down from $119,904,000 at the end of 2024, a decline of 6.1%[32] Strategic Focus - The company anticipates continued growth in DANYELZA and plans to optimize its commercial potential[26] - The company is focused on expanding its clinical development efforts and exploring new strategic partnerships to enhance its market position[26]

Core Viewpoint - Y-mAbs Therapeutics, Inc. is set to hold a virtual Radiopharmaceutical R&D update on May 28, 2025, focusing on its ongoing clinical trials and pipeline strategy for cancer treatment [1][2]. Group 1: Upcoming Event Details - The virtual update will cover Part A clinical data from the ongoing Phase 1 GD2-SADA clinical trial, including pharmacokinetic and dosimetry data [2]. - The update will also include information on nonclinical optimization studies for the GD2-SADA asset and plans for clinical implementation [2]. - The duration of the update is expected to be 90 minutes, with a live audio webcast available on the company's Investor Relations website [3]. Group 2: Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [4]. - The company utilizes technologies such as the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies generated using the Y-BiClone platform [4]. - The product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in specific patient populations [4].

Core Viewpoint - Y-mAbs Therapeutics reported solid financial results for Q1 2025, highlighting growth in DANYELZA net product revenue and advancements in its SADA PRIT platform, while also managing operational costs prudently [2][4][20]. Financial Results - Total net product revenues for Q1 2025 were $20.9 million, an 8% increase from $19.4 million in Q1 2024 [4][7]. - U.S. DANYELZA net product revenues decreased by 28% to $13.4 million, while Ex-U.S. revenues increased by $6.7 million to $7.5 million [8][9]. - Gross profit remained stable at $17.9 million, with gross margins of 86% in Q1 2025 compared to 89% in Q1 2024 [14]. - Operating costs included $11.4 million in R&D expenses, down from $13.3 million in the previous year, and $13.1 million in SG&A expenses, up from $11.4 million [15][16]. - The net loss for Q1 2025 was $5.2 million, or ($0.12) per share, an improvement from a net loss of $6.6 million, or ($0.15) per share, in Q1 2024 [18]. Corporate Developments - The National Comprehensive Cancer Network updated its guidelines to include DANYELZA as a Category 2A treatment option for high-risk neuroblastoma [5]. - The first patient was dosed in the Phase 1 clinical trial (Trial 1201) for CD38-SADA pretargeted radioimmunotherapy in relapsed/refractory non-Hodgkin Lymphoma [5][6]. - The company plans to host a virtual R&D update on May 28, 2025, to discuss clinical data and future strategies [4][12]. Cash Position and Guidance - As of March 31, 2025, Y-mAbs had cash and cash equivalents of $60.3 million, expected to support operations into 2027 [19][25]. - The company reiterated its full-year 2025 revenue guidance of $75 million to $90 million and projected Q2 2025 revenues between $17 million and $19 million [20][21].

Core Viewpoint - Y-mAbs Therapeutics, Inc. announced that naxitamab-gqgk (DANYELZA®) has been recommended as a Category 2A treatment option for high-risk neuroblastoma by the National Comprehensive Cancer Network (NCCN) [1][2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [8] - The company’s product pipeline includes DANYELZA (naxitamab-gqgk), which is the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in patients who have shown a partial response, minor response, or stable disease to prior therapy [8] Product Information - Naxitamab-gqgk (DANYELZA) was granted accelerated approval by the FDA on November 25, 2020, for pediatric patients aged one year and older and adult patients with relapsed or refractory high-risk neuroblastoma [3] - The approval was based on efficacy results from two single-arm, open-label trials [3] - DANYELZA is indicated for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) [6] - The product includes a Boxed Warning for serious infusion-related reactions and neurotoxicity [6] NCCN Guidelines - The NCCN is a not-for-profit alliance of 33 leading cancer centers focused on advancing quality cancer care [4] - The inclusion of DANYELZA in the NCCN Guidelines reinforces its position as a leading anti-GD2 therapy for high-risk neuroblastoma [2]