Glycomimetics Inc (GLYC) SEC Filing 10-Q Quarterly Report for the period ending Friday, September 30, 2022

EXHIBIT 99.1

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GlycoMimetics Reports Highlights and Financial Results for Third Quarter 2022

ROCKVILLE, Md.--(BUSINESS WIRE) – November 9, 2022-- 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 third quarter ended September 30, 2022. Cash and cash equivalents as of September 30, 2022, were $51.6 million.

“Blinded pooled survival data in our pivotal Phase 3 study show patients living longer than what would be expected based on publicly available historical data. We approached the FDA as we felt an ethical obligation to conduct an interim analysis and have the independent DMC assess whether the prolonged survival observed is linked to treatment with uproleselan,” said Harout Semerjian, Chief Executive Officer. “We are pleased the FDA is aligned with our position. Whether the DMC recommends that we continue the study as originally planned or immediately unblind for full analysis, we remain confident and excited in the potential of uproleselan to improve outcomes in relapsed/refractory AML.”

The statistical plan cleared with FDA is for the independent DMC to review efficacy and safety data at around 80% of planned survival events. The company has initiated the required regulatory and Institutional Review Board (IRB) approvals to amend the protocol to conduct the interim utility analysis and share the data with the DMC by end of Q1 2023. The DMC is then expected to meet to review the data and recommend whether the study should continue as planned or should be immediately unblinded for full analysis, which could occur if the efficacy data from treatment with uproleselan in combination with standard chemotherapy is observed to be compelling.

As part of its ongoing monitoring of blinded pooled survival data within the Phase 3 pivotal study, the company is now projecting the final survival events trigger to occur around year-end 2023. This change in timeline is the result of patients continuing to live longer than observed in historical benchmarks used to design the study and was the primary rationale for the company to approach the FDA regarding conduct of an interim utility analysis.