GlycoMimetics Plans Strategic Review and Restructuring

GlycoMimetics, Inc. (Nasdaq: GLYC), a biotechnology firm focused on developing therapies for cancer and inflammatory diseases, has announced a strategic review and corporate restructuring plan. The company has engaged Lucid Capital Markets to act as a strategic advisor. The initiative is aimed at exploring a range of strategic alternatives to deliver value to shareholders and further the clinical development of their promising drug candidates, uproleselan and GMI-1687.

Harout Semerjian, the CEO of GlycoMimetics, stated that the organization is committed to acting in the best interests of patients, employees, and shareholders. He emphasized that both uproleselan and GMI-1687 have the potential to address significant unmet needs in their respective therapeutic areas. The company is focused on finding partners to advance these programs and is proud of its team’s dedication to improving patient lives.

As of March 31, 2024, GlycoMimetics reported having approximately $31.3 million in cash and cash equivalents. The corporate restructuring and streamlining of operations are expected to significantly reduce future operating expenses and extend the company’s financial runway into the second quarter of 2025.

A key focus of GlycoMimetics is the ongoing National Cancer Institute (NCI) Phase 2/3 study of uproleselan for newly diagnosed acute myeloid leukemia (AML) patients. This adaptive study, conducted by the NCI and the Alliance for Clinical Trials in Oncology, targets adults aged 60 and older who are fit for intensive chemotherapy. The trial is evaluating the addition of uproleselan to a standard chemotherapy regimen (cytarabine/daunorubicin) versus chemotherapy alone. The Phase 2 portion of the study completed enrollment of 267 patients in December 2021.

AML is the most common acute leukemia in adults, with nearly 21,000 new cases diagnosed annually in the United States. Despite available treatments, the prognosis for AML patients remains poor. Newly diagnosed AML has the lowest 5-year survival rate among leukemias at 31.7%, and the rate drops to 10% for those with relapsed or refractory disease.

Uproleselan, discovered and developed by GlycoMimetics, is an investigational E-selectin antagonist. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy and Fast Track designations for uproleselan as a potential treatment for adult AML patients with relapsed or refractory disease. The Chinese National Medical Products Administration has also granted Breakthrough Therapy designation for the drug. E-selectin is a molecule involved in leukocyte adhesion, and in AML, it helps leukemic cells survive and evade treatment. Uproleselan is designed to disrupt this binding, thereby preventing leukemic cells from using the protective niche of the bone marrow environment.

GlycoMimetics has also developed GMI-1687, a highly potent E-selectin antagonist that is bioavailable after subcutaneous administration. This second-generation compound has potential applications in oncology and inflammatory diseases, with initial clinical development focusing on sickle-cell disease (SCD). E-selectin plays a significant role in vaso-occlusive events (VOEs) associated with SCD, such as vaso-occlusive pain crises, acute chest syndrome, stroke, and splenic sequestration. If successfully developed and approved, subcutaneous administration of GMI-1687 may provide a patient-controlled, point-of-care treatment option.

GlycoMimetics, headquartered in Rockville, MD, is dedicated to discovering and developing glycobiology-based therapies for cancer and inflammatory diseases. Their approach leverages the role of carbohydrates in cell recognition to develop small molecule drugs that alter carbohydrate-mediated recognition in various diseases. The company aims to create transformative therapies for conditions with high unmet medical needs.