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]

NEW YORK, April 25, 2025 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced that the first patient has been administered both the first protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial evaluating the Company’s Self-Assembly and Disassembly ...

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 67.7 million, reflecting a decrease of USD 11.4 million from the previous year [13][47] - The net loss for Q4 2024 was USD 6.8 million, compared to a net loss of USD 1 million in Q4 2023, with a full year net loss of USD 29.7 million [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 saw continued institutional adoption of DANYELZA, with 7 new hospital formularies added in 2024 [24] Company Strategy and Development Direction - The company announced a strategic realignment to establish 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][17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from competition, particularly from naxitamab trials, but expressed confidence in DANYELZA's growth potential [12] - 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, general, and 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 [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 [63][64] 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 [113] Question: What drives fluctuations in cost of goods sold? - Variations in batch costs and inventory write-offs contribute to fluctuations in cost of goods sold [115][117]

Y-mAbs Therapeutics, Inc. (YMAB) came out with a quarterly loss of $0.15 per share versus the Zacks Consensus Estimate of a loss of $0.13. This compares to loss of $0.02 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -15.38%. A quarter ago, it was expected that this company would post a loss of $0.14 per share when it actually produced a loss of $0.16, delivering a surprise of -14.29%.Over the last four quarters, the company ...

Drug Development and Approval - DANYELZA (naxitamab-gqgk) received accelerated FDA approval in November 2020 for treating pediatric and adult patients with relapsed or refractory high-risk neuroblastoma [703]. - The ongoing pivotal-stage multicenter trial (Study 201) for DANYELZA aims to enroll a minimum of 80 evaluable patients, with 109 patients currently enrolled and expected completion by March 31, 2027 [704]. - A Phase 2 trial evaluating naxitamab in combination with standard induction therapy for newly diagnosed high-risk neuroblastoma is ongoing, with 12 patients treated so far [707]. - The company is considering advancing a diagnostic tool for GD2 to support potential pivotal trials in GD2-related indications [706]. Financial Performance - The company reported an accumulated deficit of $487.1 million as of December 31, 2024, with a net loss of $29.7 million for the year [721]. - Total revenues increased by $2.9 million, or 3%, from $84.8 million in 2023 to $87.7 million in 2024, driven by a 400% increase in license revenue [766]. - Net product revenue rose from $84.3 million in 2023 to $85.2 million in 2024, with international revenue increasing by $2.7 million, or 16%, while U.S. revenue decreased by $1.8 million, or 3% [768]. - Gross profit decreased from $73.5 million in 2023 to $72.7 million in 2024, resulting in a gross margin decline from 87% to 82% due to a less favorable price mix [774][775]. - The net loss for 2024 was $29.7 million, compared to a net loss of $21.4 million in 2023, representing an increase in loss of $8.2 million, or 38% [766]. Research and Development - Research and development expenses have decreased compared to historical averages, with a focus on the commercialization and potential label extension of DANYELZA [738]. - Research and development expenses decreased by $5.2 million, or 10%, from $54.2 million in 2023 to $49.0 million in 2024, primarily due to a reduction in milestone and license acquisition costs [778][779]. - The transition of DANYELZA manufacturing from Greenville, North Carolina, to Monza, Italy, is expected to occur in the second half of 2026, potentially increasing research and development expenses due to the FDA approval process [738]. - The company has deprioritized several pipeline programs, including the GD2-GD3 Vaccine and CD33 bispecific antibody constructs, to focus on DANYELZA and SADA PRIT technology [715]. Operational Changes - A strategic restructuring plan was completed in May 2023, resulting in a 35% reduction in workforce to extend cash resources and prioritize DANYELZA commercialization [715]. - A business realignment plan announced in January 2025 aims to optimize operations and is expected to reduce the workforce by up to 13% by the first half of 2026 [716]. - The company has deprioritized the development of omburtamab and other product candidates, focusing resources on DANYELZA and SADA PRIT technology [738]. Revenue and Expenses - Selling, general, and administrative expenses primarily include employee-related costs, legal fees, and compliance-related expenses [739]. - Selling, general, and administrative expenses increased by $9.7 million, or 22%, from $44.9 million in 2023 to $54.6 million in 2024, influenced by legal settlements and increased personnel costs [781]. - Cost of goods sold increased by $3.6 million, or 32%, from $11.4 million in 2023 to $15.0 million in 2024, including $0.6 million in inventory write-offs [773]. - License revenue for 2024 totaled $2.5 million, a significant increase from $0.5 million in 2023, primarily due to a new distribution agreement with Nobelpharma [771][772]. Cash Flow and Financing - As of December 31, 2024, the company had cash and cash equivalents of $67.2 million, down from $78.6 million in 2023, and expects this to be sufficient to fund operations into 2027 [785]. - Net cash used in operating activities decreased to $15.7 million in 2024 from $27.2 million in 2023, representing a 42% reduction [787]. - Net cash provided by financing activities increased significantly to $4.3 million in 2024 from $0.1 million in 2023, a 4,211% increase [791]. - The company plans to advance the development of pipeline programs and may need substantial additional funding for ongoing operations [793]. Market and Economic Factors - The company faces potential pricing pressures and inflationary factors that may adversely affect operating results and cash flows [802]. - The company cannot assure that it will be able to obtain additional capital from new financing or collaborations, which may affect its research and development programs [793]. - Total operating lease commitments as of December 31, 2024, amount to $1.883 million, with $942,000 due within one year [799]. - The company has entered into sublicenses and distribution agreements in various regions, including Eastern Europe and Japan, which may impact future revenue [801].

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. reported financial results for Q4 and full year 2024, highlighting a total revenue of $26.5 million for Q4 and $87.7 million for the full year, marking a 13% and 3% increase respectively compared to the previous year [5][8][23] - The company experienced a strategic realignment in January 2025, establishing two business units focused on DANYELZA and Radiopharmaceuticals to enhance clinical development and commercial growth [6][5] - The U.S. DANYELZA net product revenues decreased by 12% in Q4 and 3% for the full year, while international revenues increased significantly by 78% in Q4 and 16% for the full year [9][10] Financial Performance - Total revenues for Q4 2024 were $26.5 million, a 13% increase from $23.4 million in Q4 2023, driven by a $2.0 million increase in license revenue and a $1.1 million increase in net product revenues [7] - For the full year 2024, total revenues reached $87.7 million, up from $84.8 million in 2023, with a $2.9 million increase attributed to license and net product revenues [8] - The company reported a net loss of $6.8 million for Q4 2024, compared to a net loss of $1.0 million in Q4 2023, and a full year net loss of $29.7 million versus $21.4 million in 2023 [23] Business Developments - The company established two business units in January 2025 to optimize resources and advance its SADA PRIT platform while driving DANYELZA's commercial growth [6][5] - Y-mAbs appointed Doug Gentilcore as Senior Vice President, Head of DANYELZA Business Unit, bringing over two decades of experience in the pharmaceutical industry [6] - The company presented pharmacokinetics data for GD2-SADA at major industry conferences, providing insights into tumor exposure and plasma elimination [6] Revenue Breakdown - U.S. DANYELZA net product revenues for Q4 2024 were $16.8 million, down 12% from the previous year, while international revenues were $7.7 million, up 78% [9][10] - The company recognized $2.0 million in license revenue in Q4 2024, with total license revenues for the year at $2.5 million, including contributions from partners in Latin America and Japan [12][15] - The cost of goods sold for Q4 2024 was $7.6 million, leading to a gross profit of $18.9 million, down from $21.3 million in Q4 2023 [13][16] Future Guidance - Management provided guidance for 2025, anticipating total revenues between $75 million and $90 million and total operating costs between $129 million and $134 million [29][25] - The company expects to maintain sufficient cash and cash equivalents to fund operations into 2027, with a total annual cash investment projected between $25 million and $30 million [29][24]

Core Insights - Y-mAbs Therapeutics, Inc. announced interim data from a Phase 2 clinical trial of naxitamab combined with GM-CSF for treating relapsed/refractory high-risk neuroblastoma, published in Nature Communications [1][2] Group 1: Clinical Trial Results - The Phase 2 trial (Trial 201, NCT03363373) involved patients with relapsed/refractory high-risk neuroblastoma, showing an overall response rate (ORR) of 50% (95% CI: 36-64%, N = 52) [2][3] - Complete response (CR) and partial response (PR) rates were 38% and 12%, respectively, with 58% of responders having refractory disease and 42% having relapsed disease [3] - Among patients with evaluable bone disease, the bone compartment response was 58% (29/50), with CR at 40% and PR at 18% [3] - The bone marrow compartment response was 74% (17/23; CR, 74%) [3] - One-year overall survival was 93% (95% CI: 80-98%) and progression-free survival was 35% (95% CI: 16-54%) [3] Group 2: Safety Profile - In the safety population (N=74), treatment-related adverse events were primarily infusion-related (90%), with hypotension (58% Grade 3 and 3 Grade 4 AEs) and bronchospasm (18% Grade 3) being the most common [4] - Grade 3 pain, a known effect of anti-GD2 immunotherapy, was frequently observed but generally resolved within 15 minutes post-infusion [4] Group 3: Company Overview - Y-mAbs is focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [6] - The company’s product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma after prior therapy [6]

Company Overview - Y-mAbs Therapeutics, Inc. (YMAB) is expected to report a year-over-year decline in earnings despite higher revenues for the quarter ended December 2024, with a consensus EPS estimate of a loss of $0.13 per share, reflecting a -550% change from the previous year [1][3] - Revenues are anticipated to be $27.2 million, which represents a 16.4% increase compared to the same quarter last year [3] Earnings Expectations - The earnings report is scheduled for release on March 4, 2025, and could lead to stock price movements depending on whether the actual results exceed or fall short of expectations [2] - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4] Earnings Surprise Prediction - The Most Accurate Estimate for Y-mAbs Therapeutics is higher than the Zacks Consensus Estimate, resulting in a positive Earnings ESP of +31.65%, suggesting a bullish outlook from analysts [10] - The company currently holds a Zacks Rank of 3 (Hold), indicating a moderate expectation of beating the consensus EPS estimate [11] Historical Performance - In the last reported quarter, Y-mAbs Therapeutics was expected to post a loss of $0.14 per share but actually reported a loss of $0.16, resulting in a surprise of -14.29% [12] - Over the past four quarters, the company has only beaten consensus EPS estimates once [13] Industry Context - In the broader context of the Zacks Medical - Biomedical and Genetics industry, Apellis Pharmaceuticals, Inc. (APLS) is also expected to report a loss of $0.39 per share for the same quarter, reflecting a year-over-year change of +46.6% [17] - Apellis Pharmaceuticals has an Earnings ESP of -44.73% and a Zacks Rank of 3, making it challenging to predict a beat on the consensus EPS estimate [18]