Radiopharmaceutical R&D Update May 28, 2025 Mike Rossi President and Chief Executive Officer Natalie Tucker SVP, Radiopharmaceutical Business Unit Head Norman LaFrance, MD Chief Medical and Development Officer Additional Team Members Available During Q&A Disclaimer Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. The forward-looking statements involve substantial risks and uncertainties. All statem ...

Summary of Y-mAbs Therapeutics Inc (YMAB) Conference Call on May 28, 2025 Company Overview - **Company**: Y-mAbs Therapeutics Inc (YMAB) - **Focus**: Development of next-generation therapies, particularly in the field of radiopharmaceuticals and immunotherapy for cancer treatment [4][5] Key Industry Insights - **Radiopharmaceuticals**: The company aims to address significant gaps in the current radiopharmaceutical space through innovative approaches, including pre-targeting to reduce off-target toxicity and enhance treatment efficacy [6][8] - **Theranostic Platform**: YMAB is working towards a fully operational theranostic platform that combines novel radioimmunotherapies with diagnostic tools [6] Core Points Discussed 1. **Clinical Trial Updates**: - The company reported on the progress of its GD2 SADA Phase 1 clinical trial (Trial 1,001), achieving the primary endpoint of safety and tolerability [14][24] - The trial included 23 patients, with a diverse representation across various cancer types, including sarcoma, melanoma, and high-risk neuroblastoma [22][41] 2. **Safety Profile**: - No dose-limiting toxicities or serious adverse events were observed, indicating a robust safety profile for the GD2 SADA protein and Luedota [24][29] - Most adverse events were mild (grade one and two), with nausea and lymphopenia being the most common [26][28] 3. **Pharmacokinetics (PK)**: - The PK of GD2 SADA protein was found to be predictable and dose-dependent, which is crucial for optimizing dosing intervals and maximizing therapeutic indices [30][41] - The study demonstrated that higher concentrations of GD2 SADA showed slower clearance rates, which is beneficial for treatment efficacy [32] 4. **Tumor Uptake Analysis**: - Expanded evaluations showed a higher number of patients with tumor uptake than initially reported, indicating the potential for broader patient eligibility for treatment [42][67] - The company emphasized the importance of using SPECT imaging to identify GD2 expression, which may lead to better patient selection [59][67] 5. **Future Development Plans**: - YMAB plans to initiate a bridge study in early 2026 to evaluate the new Proteus radiohapton, with results expected by the end of 2026 [46][81] - The company is also working on a GD2 PET diagnostic to enhance patient selection and expedite the development of its therapeutic programs [51][78] 6. **Target Evaluation**: - The company has narrowed down potential high-value targets for its pre-targeting platform, focusing on cancers with high unmet needs, particularly in lung, women's, and gastrointestinal cancers [47][48] Additional Important Insights - **Modular Platform**: The introduction of the Proteus radiohapton is expected to improve tumor uptake and reduce off-target effects, enhancing the overall therapeutic index [45][69] - **Regulatory Engagement**: YMAB is actively working with the FDA on its next IND for a new GD2 PET diagnostic, which is anticipated to facilitate the development of its therapeutic assets [46][51] - **Patient-Centric Approach**: The company emphasizes a patient-centric treatment model, allowing for personalized therapy based on individual tumor characteristics and responses [10][10] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting the company's strategic direction and advancements in the field of radiopharmaceuticals.

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].