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Y-mAbs Therapeutics Inc (YMAB) Earnings Call Presentation
2025-05-28 14:30
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 ...
Y-mAbs Presents GD2-SADA PRIT Trial in Progress Poster at the Advances in Neuroblastoma Research Meeting
GlobeNewswire News Room· 2025-05-26 14:00
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]
Y-mAbs to Host Virtual Radiopharmaceutical R&D Update on May 28, 2025
Globenewswire· 2025-05-13 11:05
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].
Y-mAbs Reports First Quarter 2025 Financial Results and Recent Corporate Developments
Globenewswire· 2025-05-13 10:35
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].
Y-mAbs Announces Update to National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma to Include Naxitamab-gqgk (DANYELZA®)
Globenewswire· 2025-05-07 11:05
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]
Y-mAbs to Announce First Quarter 2025 Financial and Operating Results on May 13, 2025
Globenewswire· 2025-05-06 11:05
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]
Y-mAbs Presents Translational Pharmacokinetics of CD38-SADA from Pretargeted RIT Platform at 2025 American Association for Cancer Research (AACR) Annual Meeting
Globenewswire· 2025-04-27 19:00
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]
Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating CD38-SADA Pre-targeted Radioimmunotherapy in Relapsed/Refractory Non-Hodgkin Lymphoma
Globenewswire· 2025-04-25 11:35
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]
Y-mAbs(YMAB) - 2024 Q4 - Earnings Call Transcript
2025-03-04 20:03
Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) Q4 2024 Earnings Conference Call March 4, 2025 8:00 AM ET Company Participants Courtney Dugan - Head-IR Michael Rossi - President & CEO Doug Gentilcore - Senior VP & Head of DANYELZA Business Unit Natalie Tucker - Radiopharmaceutical Business Unit Head Peter Pfreundschuh - CFO Conference Call Participants Alec Stranahan - Bank of America Michael Wolf - Morgan Stanley Jeff Jones - Oppenheimer Nicole Germino - Truist Li Watsek - Cantor Fitzgerald William Maughan - Clear ...