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May 23, 2015 1:03 AM ET

Biotechnology

Company Overview of GlycoMimetics, Inc.

Company Overview

GlycoMimetics, Inc., a clinical stage biotechnology company, focuses on the discovery and development of glycomimetic drugs to address unmet medical needs resulting from diseases in the United States. The company develops lead product rivipansel, a glycomimetic drug candidate that has completed Phase II clinical trials for the treatment of vaso-occlusive crisis, a debilitating and painful condition that occurs periodically throughout the life of a person with sickle cell disease. It also develops GMI-1271, a specific E-selectin antagonist to treat acute myeloid leukemia and other hematologic cancers; and GMI-1051 and other drug candidates for pseudomonas virulence factors. The company has a ...

401 Professional Drive

Suite 250

Gaithersburg, MD 20879

United States

Founded in 2003

34 Employees

Phone:

240-243-1201

Fax:

240-243-1018

Key Executives for GlycoMimetics, Inc.

Co-Founder, Chief Executive Officer, President and Director
Age: 55
Total Annual Compensation: $417.0K
Chief Financial Officer and Principal Accounting Officer
Age: 40
Total Annual Compensation: $285.4K
Chief Medical Officer and Vice President of Clinical Development
Age: 46
Total Annual Compensation: $345.0K
Chief Scientific Officer, Vice President of Research and Director
Age: 61
Total Annual Compensation: $309.8K
Compensation as of Fiscal Year 2014.

GlycoMimetics, Inc. Key Developments

GlycoMimetics, Inc. Initiates Phase 1/2 Clinical Trial of GMI-1271 as Potential Treatment for Acute Myeloid Leukemia in Combination with Chemotherapy

GlycoMimetics, Inc. announced that the first patient has been dosed in a Phase 1/2 clinical study designed to evaluate the safety, pharmacokinetics (PK) and efficacy of GMI-1271, a novel and proprietary E-selectin antagonist in the company’s pipeline, when used in combination with chemotherapy in patients with acute myeloid leukemia (AML). GlycoMimetics is initially exploring the clinical use of the drug candidate in hematologic malignancies following the successful completion of a Phase 1 healthy volunteer study late last year. The Company announced last week that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug designation to GMI-1271 for treatment of AML. This Phase 1/2, open-label multicenter study is designed to determine safety, PK and efficacy of GMI-1271 in combination with chemotherapy in male and female adult patients with AML. Study sites are located in the United States, Australia and Ireland. While the primary objective is to analyze safety, additional endpoints include: mobilization of AML blasts, effect on neutropenia, time to and duration of remission, evaluation of event-free survival and evaluation of the overall survival probability at six- and 12-months. Approximately 77 subjects will be enrolled. The study will include a dose escalation phase followed by expansion of the study once the dose for the Phase 2 portion has been selected. AML: Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults, and it is estimated that there will be over 18,000 new cases and over 10,000 deaths from the disease in 2014. Unlike other cancers that start in an organ and spread to the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow and as a result, impede normal blood cell production. While leukemic cells move into the blood, the lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment options for AML are chemotherapy and stem cell transplantation, both of which can destroy cancer cells but do not reduce the related side effects.

FDA Grants Orphan Drug Designation to GlycoMimetics’ GMI-1271 for Treatment of Acute Myleogenous Leukemia (AML)

GlycoMimetics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to GMI-1271, a novel and proprietary E-selectin antagonist in the company’s pipeline for treatment of patients with acute myeloid leukemia (AML). GlycoMimetics is currently recruiting patients in a Phase 1/2, open-label multicenter study designed to evaluate the safety, pharmacokinetics and efficacy of GMI-1271 in combination with chemotherapy in adult patients with AML; a Phase 1 study in healthy volunteers was completed last year. The FDA’s Orphan Drug designation program is designed to promote the development of promising therapeutics for the treatment of rare diseases affecting fewer than 200,000 people in the United States. Orphan Drug designation includes benefits such as a potential seven-year period of U.S. marketing exclusivity after approval. Other potential advantages include protocol assistance, the ability to apply for research funding, tax credits for certain research expenses, and regulatory fee waivers. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults, and it is estimated that there were over 18,000 new cases and over 10,000 deaths from the disease in 2014. Unlike other cancers that start in an organ and spread to the bone marrow, AML is associated with rapid growth of abnormal white blood cells that gather in the bone marrow and, as a result, impede normal blood cell production. While leukemic cells move into the blood, the lack of normal blood cells can lead to a number of symptoms, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment options for AML include chemotherapy and stem cell transplantation, both of which can destroy cancer cells but do not reduce the related side effects.

GlycoMimetics, Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015

GlycoMimetics, Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported loss from operations of $7,113,000, net loss and comprehensive loss of $7,109,000 or $0.37 per basic and diluted share compared to the loss from operations of $5,107,000, net loss and comprehensive loss of $5,102,000 or $0.30 per basic and diluted share for the same quarter year ago. The company reported no revenue for the quarter ended March 31, 2015 or the quarter ended March 31, 2014.

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