GlycoMimetics, Inc. (NASDAQ:GLYC) presented in a poster at the 57th American Society of Hematology (ASH) Annual Meeting first-in-human Phase 1 results that showed a favorable safety, pharmacokinetic and biomarker profile for its drug candidate GMI-1271, which is being investigated as a treatment for acute myeloid leukemia (AML) and other blood cancers.

“We are encouraged to see this biomarker evidence, demonstrating the ability of GMI-1271 to target and reduce E-selectin as predicted,” said Helen Thackray, M.D., Vice President and Chief Medical Officer of GlycoMimetics. “We will continue to test the safety and effectiveness of GMI-1271 for AML in our Phase 1/2 trial, and we expect to report an initial top line data set from that trial in the middle of 2016.”

The data presented at ASH, prepared by researchers at GlycoMimetics and the University of Michigan, is from two Phase 1 studies of 52 healthy volunteers. It showed that GMI-1271 was well tolerated with no serious adverse effects, demonstrating increased concentrations in plasma that were dose-dependent. Several key biomarker findings supportive of the targeted mechanism of the drug were reported, including the absence of any increase in bleeding times compared to low molecular weight heparin and the absence of a rise in CD34+ hematopoietic stem cells (an indication that the compound does not adversely stimulate the bone marrow to release primitive cells). In addition, increasing doses of GMI-1271 significantly reduced levels of the biomarker E-selectin, a cell adhesion molecule that binds to cancer cells and is a key component of drug resistance by blood cancers.

GMI-1271 targets E-selectin, a cell adhesion molecule that aids in blood cancer cell resistance to chemotherapy. Preclinical studies have shown on a cellular level how GMI-1271 can overcome E-selectin-induced resistance to chemotherapy in AML and other blood cancers. The drug candidate is in a Phase 1/2 clinical study designed to evaluate its safety, pharmacokinetics (PK) and efficacy when used together with chemotherapy for AML. Preclinical studies have also shown beneficial effect on thrombosis without increasing bleeding time. University of Michigan researchers are evaluating the drug for potential to aid in the treatment of thrombosis.

The abstract (Abstract #1004), entitled “First in Human Phase 1 Single Dose Escalation Studies of the E-Selectin Antagonist GMI-1271 Show a Favorable Safety, Pharmacokinetic, and Biomarker Profile,” is available at ASH’s website.

About GlycoMimetics, Inc.

GlycoMimetics is a clinical stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics entered into an exclusive license agreement with Pfizer for rivipansel in October 2011. Under the license agreement, Pfizer is responsible for the clinical development, regulatory approval and potential commercialization of rivipansel, which is currently being evaluated in a Phase 3 study for treatment of vaso-occlusive crisis of sickle cell disease.

GlycoMimetics’s wholly-owned drug candidate (GMI-1271) for AML and other blood disorders is also in clinical trials. Glycomimetics are molecules that mimic the structure of carbohydrates involved in important biological processes. Using its expertise in carbohydrate chemistry and knowledge of carbohydrate biology, GlycoMimetics is developing a pipeline of glycomimetic drug candidates that inhibit disease-related functions of carbohydrates, such as the roles they play in inflammation, cancer and infection. Learn more at www.glycomimetics.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding the clinical development of the GMI-1271 and the presentation of data. Actual results may differ materially from those in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the company’s annual report on Form 10-K that was filed with the U.S. Securities and Exchange Commission on March 16, 2015, and other filings the company makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.