Patients continue to live longer than expected, so clinical trial will have to continue longer than they expected before they fully unblind the results.
[Has the standard of care improved since they initially designed the study?]
Significant progress in strengthening leadership, raising capital, and preparing for final results of the uproleselan Phase 3 study in relapsed/refractory (R/R) acute myeloid leukemia (AML)
Interim utility analysis used high statistical threshold and resulted in independent Data Monitoring Committee (DMC) recommending trial continue to final survival events, projected to occur in the first half of 2024; DMC also expressed no safety concerns about the trial
Cash and cash equivalents expected to fund current operations to year end 2024
… GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the quarter and year ended December 31, 2022. Cash and cash equivalents as of December 31, 2022 were $47.9 million. After year-end, the company raised an additional $28.7 million in net proceeds from its "at-the-market" (ATM) sales facility.
"In 2022, we made great strides in our continued organizational evolution, strengthening our leadership team and financial position as we aspire to become a commercial-stage company capable of delivering uproleselan to R/R AML patients in need of innovative new treatment options," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "Patients continue to live longer in our pivotal Phase 3 study of uproleselan, with duration of median follow-up for the blinded, pooled patient population now at a remarkable 25 months. Our Phase 3 AML trial projects to have the longest duration of median follow-up at time of primary analysis of any study, to our knowledge, previously conducted in this disease area. We remain optimistic and excited about the potential of uproleselan to improve overall survival in R/R AML."
… GlycoMimetics strengthened its clinical and commercial leadership team in 2022 and early 2023 with the appointments of Edwin Rock, MD, Ph.D. as Chief Medical Officer, Deepak Tiwari as Vice President of Technical Operations, Bruce Johnson as Chief Commercial Officer, and most recently, Chinmaya Rath as Chief Business Officer.