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]

Core Insights - Y-mAbs Therapeutics, Inc. is set to report its first quarter 2025 results on May 13, 2025, before market opening [1] - A conference call and webcast will be held on the same day at 8:00 a.m. ET to discuss the results, with a live audio webcast available on the company's Investor Relations website [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 [3] - The company utilizes advanced technologies such as the Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy Platform (PRIT) and bispecific antibodies from the Y-BiClone platform [3] - Y-mAbs has a broad product pipeline, including DANYELZA® (naxitamab-gqgk), which is the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in specific patient conditions [3]

Core Insights - Y-mAbs Therapeutics, Inc. presented preclinical and translational pharmacokinetics (PK) data of CD38-SADA at the 2025 AACR Annual Meeting, focusing on its potential for cancer treatment [1][2] Group 1: Presentation Details - The poster titled "Preclinical and translational pharmacokinetic (PK) modeling of the self-assembling and disassembling (SADA) bispecific fusion protein CD38-SADA for first-in-human (FIH) pretargeted radioimmunotherapy (PRIT)" was presented, detailing plasma concentrations of CD38-SADA in animal models [2][5] - The presentation took place on April 27, 2025, from 2:00 p.m. to 5:00 p.m. CT at Poster Section 25 [5] Group 2: Research Findings - The study characterized the concentration- and time-dependent equilibrium between CD38-SADA tetramers and monomers, with the model showing that low molecular weight CD38-SADA monomers cleared from plasma 20 times faster than the tetramers [3] - The preclinical PK model provided insights into the circulating levels of CD38-SADA protein in vivo, which informed the design and initial dosing regimen of the first-in-human Phase 1 Trial 1201 [4] Group 3: Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [6] - The company's product pipeline includes DANYELZA®, the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [6] Group 4: CD38-SADA PRIT Technology - CD38-SADA is a bispecific fusion protein that binds to CD38 and Lu-DOTA, facilitating a two-step pre-targeted radioimmunotherapy process [7][8] - The technology has shown robust anti-tumor efficacy in preclinical studies and is currently being investigated in adults with relapsed, progressive, or refractory non-Hodgkin lymphoma [8]

Core Insights - Y-mAbs Therapeutics has initiated its Phase 1 clinical trial (Trial 1201) for the CD38-SADA Pre-targeted Radioimmunotherapy (PRIT) platform aimed at treating relapsed or refractory non-Hodgkin Lymphoma (r/r NHL) [1][3] - The trial focuses on the safety and tolerability of the CD38-SADA: Lu-DOTA Drug Complex, with the first patient successfully administered both the protein and imaging doses [1][2] - The SADA PRIT platform is designed to enhance targeted delivery of therapeutic agents while minimizing radiation exposure to normal tissues [2][6] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company specializing in novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [5] - The company’s product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [5] Technology and Innovation - The CD38-SADA is a bispecific fusion protein that binds to CD38-expressing lymphoma cells and delivers a radioactive payload for localized irradiation [6] - The SADA technology was developed by researchers at MSK and is exclusively licensed to Y-mAbs, indicating a strong collaboration between the two entities [4]

I have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this space.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wr ...

Financial Data and Key Metrics Changes - Total revenue for the full year 2024 was USD 87.7 million, within the guidance range of USD 87 million to USD 95 million [11] - DANYELZA net product revenues for the full year 2024 were USD 85.2 million, with a fourth quarter revenue of USD 24.5 million, representing a 5% increase compared to the same period in 2023 [22][41] - The company ended 2024 with cash and cash equivalents of USD 67.2 million, a decrease of USD 11.4 million from the previous year [47] - The net loss for the fourth quarter 2024 was USD 6.8 million, compared to a net loss of USD 1 million in the same quarter of 2023 [46] Business Line Data and Key Metrics Changes - DANYELZA maintained a steady market share of 15% to 17% in the U.S. anti-GD2 market [11][23] - International DANYELZA net product revenues in Q4 2024 were USD 7.7 million, a 78% increase compared to Q4 2023, driven by the launch of a named patient program in Western Asia [26][42] - The company recorded USD 2 million in licensing revenue for Q4 2024, compared to no licensing revenue in Q4 2023 [43] Market Data and Key Metrics Changes - DANYELZA's estimated total share of the U.S. anti-GD2 market remained steady, with 69 accounts ordering the product as of December 31, 2024 [23] - The company faced competition from new market entrants and ongoing clinical trials, impacting U.S. revenues [22][41] Company Strategy and Development Direction - The company announced a strategic realignment into two distinct business units: DANYELZA and Radiopharmaceuticals, aimed at accelerating the development of the SADA PRIT platform [14][16] - The focus is on expanding radiopharmaceutical capabilities and improving capital efficiencies while maximizing DANYELZA's potential [15][16] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from competition but expressed confidence in DANYELZA's growth potential and the strength of its international markets [12][22] - The company anticipates total net revenue for 2025 to be between USD 75 million and USD 90 million, with a first quarter guidance of USD 18 million to USD 21 million [48][49] Other Important Information - Research and development expenses decreased to USD 49 million for the year ended December 31, 2024, from USD 54.2 million in 2023 [44] - Selling and general administrative expenses increased to USD 54.6 million for the year ended December 31, 2024, primarily due to legal settlements and personnel costs [45] Q&A Session Summary Question: Should we expect a flat trajectory for DANYELZA revenue in 2025? - Management indicated plans to accelerate growth, with some ramp-up expected as they support clinical trials and seek additional market penetration [54][55] Question: What tissues will be important for dose selection in the upcoming SADA update? - Key areas include the kidney, liver, and bone marrow, with a focus on potential dose-limiting toxicities [62][63] Question: Can you provide a breakdown of the 2025 OpEx guidance? - The OpEx guidance of USD 116 million to USD 121 million excludes cost of goods, with SG&A costs expected to grow slightly from the previous year [68][72] Question: How will investigator-sponsored studies impact DANYELZA revenue? - Continued investment in investigator-sponsored trials is expected to increase market penetration and support additional indications [76][78] Question: What are the market dynamics in neuroblastoma with the introduction of DFMO? - DFMO may provide temporary solutions, but patients will likely return to anti-GD2 therapies as their condition progresses [112][113] Question: What drives fluctuations in cost of goods sold? - Variations in batch costs and inventory write-offs contribute to fluctuations in COGS [116][117]