NEW YORK - Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB), a biopharmaceutical company specializing in cancer treatments, has announced new clinical and preclinical data for its therapies naxitamab and GD2-SADA in neuroblastoma. The findings were presented at the American Academy of Cancer Research Special Conference on September 6-7, 2024, in Toronto, Canada.
The study on naxitamab, titled "Disease control in patients treated with naxitamab for refractory/relapsed high-risk neuroblastoma," was shared on September 7 during poster session B. The interim analysis from Trial 201 (NCT03363373) showed a 63% disease control rate in patients with high-risk neuroblastoma with residual disease in the bone or bone marrow. These patients were treated with naxitamab in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Chief Medical Officer Vignesh Rajah, MBBS, DCH, MRCP (UK), highlighted the importance of maintaining disease control for patients at high risk of disease progression.
In another study, "GD2-SADA, a bispecific fusion protein that forms self-assembling and disassembling (SADA) GD2-avid tetramers with high affinity for chelated radiolanthanides" (poster #A075), researchers presented data on September 6. The study demonstrated strong binding between GD2-SADA and DOTA-chelated terbium, a metal useful in medical diagnosis and therapy. The self-assembly and disassembly of GD2-SADA allow for targeted delivery of cytotoxic radiation to tumors with minimal exposure to non-targeted areas.
These findings are informing ongoing pharmacokinetic/pharmacodynamic (PK/PD) modeling and the initial dosing in Trial 1001 (NCT05130255), a Phase 1 trial of GD2-SADA PRIT with 177Lu-DOTA in adolescent and adult patients with GD2-positive solid tumors, and the planned Trial 1002 for pediatric patients with high-risk neuroblastoma.
Y-mAbs Therapeutics has licensed both naxitamab-gqgk, a treatment for high-risk neuroblastoma, and the SADA technology for radioimmunotherapy from Memorial Sloan Kettering Cancer Center (MSK), which has institutional financial interests in the compounds and technology.
The company continues to focus on the development of novel radioimmunotherapy and antibody-based therapeutic cancer products, aiming to improve patient outcomes. This article is based on a press release statement from Y-mAbs Therapeutics, Inc.
In other recent news, Y-mAbs Therapeutics has reported mixed results in its second-quarter earnings for 2024, with a 10% increase in total DANYELZA net product revenue to $22.8 million, driven by a 55% surge in international orders. However, the firm experienced a 4% drop in US DANYELZA revenue, falling to $15.2 million, attributed to new competitive therapies and ongoing clinical trials. The company's full-year net revenue is projected between $87 million and $95 million, with a net loss of $9.2 million reported for Q2.
Cantor Fitzgerald has initiated coverage on Y-mAbs, providing an Overweight rating and a price target of $20.00, citing the company's innovative approach to radiopharmaceuticals. Meanwhile, BMO Capital Markets has adjusted its price target for Y-mAbs, bringing it down to $25.00 from the previous $26.00, while maintaining an Outperform rating for the stock.
In the wake of these developments, Y-mAbs has been focusing on its proprietary pretargeting radioimmunotherapy (PRIT) platform, SADA, which is designed to enhance the delivery of radiopharmaceuticals to tumor cells. The company is also progressing with its Phase I trial for GD2-SADA, with Cohort 5 currently being tested. These recent developments present Y-mAbs Therapeutics with both opportunities and challenges in the evolving landscape of radiopharmaceuticals.
InvestingPro Insights
As Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) presents promising data for its cancer treatments, investors and stakeholders may be keen to understand the company's financial health and market performance. According to InvestingPro data, Y-mAbs boasts a market capitalization of approximately $623.53 million, reflecting the market's current valuation of the company. The firm's commitment to innovation in cancer therapy is reflected in its impressive gross profit margin, which stands at 88.62% for the last twelve months as of Q2 2024. This metric underscores the company's efficiency in managing production costs relative to its revenue, a positive sign for potential investors.
Despite not being profitable over the last twelve months, with a negative operating income margin of -31.94%, Y-mAbs has managed to maintain a strong return over the past year, with a 187.86% price total return. This performance may be indicative of investor confidence in the company's growth prospects and its therapies' potential market impact. Additionally, an InvestingPro Tip highlights that the company holds more cash than debt on its balance sheet, providing it with a solid liquidity position to fund its operations and research endeavors.
Investors should note that Y-mAbs does not pay a dividend, which is common for companies in growth phases and those reinvesting earnings into research and development. Furthermore, two analysts have revised their earnings forecasts downwards for the upcoming period, suggesting that investors may want to keep an eye on future earnings announcements. For those looking for more in-depth analysis, InvestingPro offers additional tips on Y-mAbs Therapeutics, Inc., which can be found at https://www.investing.com/pro/YMAB.
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