Full Press Release Details
GLYCOMIMETICS REPORTS FOURTH QUARTER AND YEAR-END 2016 RESULTS
ROCKVILLE, MD, March 1, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) today reported progress on its clinical development programs and its financial results for the fourth quarter and year ended December 31, 2016.
In 2016, GlycoMimetics made significant progress across its clinical pipeline, perhaps most significantly in the maturing data from our study of GMI-1271, an E-selectin antagonist, in acute myeloid leukemia (AML). Starting early in the year, continuing mid-year at the European Hematology Association (EHA), and finally, in December at the 58th Annual American Society of Hematology (ASH) Annual Meeting, we presented results from the Phase 2 portions of this study, in both newly diagnosed and relapsed/refractory patients. The ongoing trial is expected to complete enrollment in the first half of this year. Importantly the data to date suggest a very real potential for bringing a differentiated commercial product to this vastly underserved market.
Beyond this program, we initiated two new trials in 2016, a Phase 1 clinical trial of GMI-1271 in multiple myeloma (MM), and a Phase 1 clinical trial of our next drug candidate GMI-1359, a dual antagonist of both E-selectin and CXCR4, in healthy volunteers. These accomplishments position us for significant news flow in 2017. In addition, the Phase 3 trial of rivipansel being conducted by Pfizer continues to enroll sickle cell patients with the goal of completion of enrollment in the second half of 2018, said Rachel King, GlycoMimetics' Chief Executive Officer.
Key Operational Highlights for the Fourth Quarter of 2016:
Fourth Quarter 2016 Financial Results:
GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug's potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at ASH meetings, GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on cancer and sickle cell disease. GlycoMimetics' most advanced drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer. GlycoMimetics' wholly-owned drug candidate, GMI-1271, an E-selectin antagonist, is being evaluated in an ongoing Phase 1/2 clinical trial as a potential treatment for AML and in a Phase 1 clinical trial as a potential treatment for MM. GlycoMimetics has also recently completed dosing in a clinical trial with a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. 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 company's drug candidates and the presentation of clinical 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 (SEC) on March 1, 2017, and other filings GlycoMimetics 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.
Source: GlycoMimetics
Email: sannes@annesassociates.com
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Condensed Statements of Operations
(In thousands, except share and per share data)
| Three months ended December 31, | Year ended December 31, | |||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||
| (Unaudited) | ||||||||||||
| Revenue | $ | $ | 35 | $ | 18 | $ | 20,071 | |||||
| Costs and expenses: | ||||||||||||
| Research and development expense | 6,060 | 6,961 | 23,282 | 25,050 | ||||||||
| General and administrative expense | 2,298 | 1,962 | 8,650 | 7,805 | ||||||||
| Total costs and expenses | 8,358 | 8,923 | 31,932 | 32,855 | ||||||||
| Loss from operations | (8,358) | (8,888) | (31,914) | (12,784) | ||||||||
| Other income | 29 | 6 | 104 | 15 | ||||||||
| Net loss and comprehensive loss | $ | (8,329) | $ | (8,882) | $ | (31,810) | $ | (12,769) | ||||
| Net loss per common share basic and diluted | $ | (0.36) | $ | (0.47) | $ | (1.50) | $ | (0.67) | ||||
| Weighted average common shares basic and diluted | 23,110,862 | 19,043,234 | 21,256,312 | 19,010,587 |
| December 31, | December 31, | ||||||
| 2016 | 2015 | ||||||
| Cash and cash equivalents | $ | 40,042 | $ | 46,803 | |||
| Working capital | 34,187 | 39,497 | |||||
| Total assets | 42,388 | 48,462 | |||||
| Total liabilities | 7,087 | 7,991 | |||||
| Total stockholders' equity | 35,301 | 40,472 |