Y-mAbs Therapeutics Plans To Deprioritize Omburtamab For Pediatric Cancer, Cuts One Third Of Workforce
Y-mAbs Therapeutics Inc (NASDAQ: YMAB) announced a strategic restructuring plan to extend its cash runway into Q1 of 2026 and prioritize resources on the commercialization and potential label extension of Danyelza and development of the SADA (Self-Assembly DisAssembly PRIT 2-STEP) technology platform.
The company plans to discuss omburtamab at its upcoming Type A meeting with the FDA; however, it has assumed a deprioritization of the omburtamab program, including all indications, in designing its restructuring plan and in its estimates for 2023.
In October, FDA's adcomm voted 16 to 0 that the company had not provided sufficient evidence to conclude that omburtamab improves overall survival.
In addition, the company plans to deprioritize other pipeline programs, including activities relating to GD2-GD3 Vaccine and CD33 bispecific antibody constructs.
Y-mAbs will reduce its workforce by approximately 35% by the end of May 2023.
Operating expenses, including restructuring costs expected to be recognized in Q1 2023, are expected to decrease by approximately 28% to $115-120 million, compared to previously announced 2022 guidance for operating expenses of $162-167 million.
The total cash burn for FY23 is expected to be $50-55 million.
Estimated DANYELZA net product revenues for FY23 are expected to be $60-65 million, compared to approximately $47-48 million expected for FY22.
Price Action: YMAB shares are down 10.40% at $4.58 on the last check Thursday.
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