Y-mAbs Therapeutics, under the ticker YMAB, has initiated a significant Phase 1 clinical trial targeting relapsed or refractory non-Hodgkin Lymphoma. The first patient has been given both the initial protein dose and the Lu-DOTA imaging dose, marking the start of its innovative treatment approach utilizing the Self-Assembly and Disassembly Pre-targeted Radioimmunotherapy platform.
This trial, recognized as Trial 1201, adopts a dose-escalation, open-label, single-arm, and multi-center format to evaluate both the safety and tolerability of the CD38-SADA: Lu-DOTA Drug Complex. The core of this study is to assess the precision of the pre-targeted delivery system. The CD38-SADA protein, known for its high affinity binding to lymphoma cells, is administered first, followed by a radioactive Lu-DOTA payload. This strategy is intended to specifically target tumor-bound CD38-SADA molecules, thereby reducing radiation exposure to healthy tissues.
Part A of the trial focuses on escalating the CD38-SADA doses while keeping the Lu-DOTA payload constant. It aims to identify the optimal dosage and timing between the two administrations. Key measurements for this phase include tumor imaging outcomes and documenting dose-limiting toxicities during the evaluation period.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 11 analysts, the average target price for Y-mAbs Therapeutics Inc (YMAB, Financial) is $15.82 with a high estimate of $26.00 and a low estimate of $3.00. The average target implies an upside of 283.01% from the current price of $4.13. More detailed estimate data can be found on the Y-mAbs Therapeutics Inc (YMAB) Forecast page.
Based on the consensus recommendation from 11 brokerage firms, Y-mAbs Therapeutics Inc's (YMAB, Financial) average brokerage recommendation is currently 2.1, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Based on GuruFocus estimates, the estimated GF Value for Y-mAbs Therapeutics Inc (YMAB, Financial) in one year is $11.50, suggesting a upside of 178.45% from the current price of $4.13. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Y-mAbs Therapeutics Inc (YMAB) Summary page.
YMAB Key Business Developments
Release Date: March 04, 2025
- Total Revenue: $87.7 million for the full year 2024.
- DANYELZA Net Product Revenues: $85.2 million for the full year 2024; $24.5 million for Q4 2024, a 5% increase from Q4 2023.
- International DANYELZA Revenues: $7.7 million for Q4 2024, a 78% increase from Q4 2023.
- US DANYELZA Revenues: $16.8 million for Q4 2024, a 12% decline from Q4 2023.
- Licensing Revenue: $2 million for Q4 2024; $2.5 million for the full year 2024.
- Research and Development Expenses: $12.2 million for Q4 2024; $49 million for the full year 2024, a decrease from $54.2 million in 2023.
- Selling and General Administrative Expenses: $12.4 million for Q4 2024; $54.6 million for the full year 2024.
- Net Loss: $6.8 million for Q4 2024; $29.7 million for the full year 2024.
- Cash and Cash Equivalents: $67.2 million as of December 31, 2024.
- 2025 Revenue Guidance: $75 million to $90 million for the full year.
- 2025 Operating Expenses Guidance: $129 million to $134 million, including cost of goods sold.
- 2025 Cash Investment Guidance: $25 million to $30 million.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Y-mAbs Therapeutics Inc (YMAB, Financial) achieved total revenue of $87.7 million for the full year 2024, within their guidance range.
- DANYELZA maintained a steady share of the US anti-GD2 market between 15% and 17%.
- The company successfully expanded its international presence, with a 78% increase in international DANYELZA net product revenues in Q4 2024.
- Y-mAbs Therapeutics Inc (YMAB) ended 2024 with $67.7 million in cash and cash equivalents, supporting their plans through 2027.
- The company announced a strategic realignment into two distinct business units to accelerate development and maximize potential.
Negative Points
- Y-mAbs Therapeutics Inc (YMAB) faced competition in the US market, impacting DANYELZA's growth.
- US DANYELZA net product revenues declined by 12% in Q4 2024 compared to the same period in 2023.
- The company reported a net loss of $6.8 million for Q4 2024, an increase from the previous year's loss.
- Research and development expenses decreased, but the company still faces high operating expenses.
- Challenges in patient enrollment for the CD38 SADA Phase 1 trial were noted, impacting trial progress.
