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, 2017.
“Highlighting the fourth quarter of 2017, GlycoMimetics presented a robust data set for its Phase 1/2 study of GMI-1271 for the treatment of AML patients. This data provided the basis for discussions with the U.S. FDA focused on a Phase 3 trial design – the result of which we announced yesterday. The ongoing discussions were made possible via our Breakthrough Therapy designation for GMI-1271 for the treatment of relapsed/refractory AML patients, and we now plan to initiate our own Phase 3 trial in this patient population later this year,” noted Rachel King, Chief Executive Officer.
Recent Operational Highlights:
Fourth Quarter 2017 Financial Results:
The company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 1453008. A webcast replay will be available via the “Investors” tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 1453008.
About GMI-1271
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. In a Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and MM or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 is currently in Phase 1 testing in healthy volunteers.
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' 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, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is currently being evaluated in a Phase 1 clinical trial for the treatment of multiple myeloma. The FDA granted GMI-1271 Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory disease. GlycoMimetics has also recently initiated a Phase 1 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, including the expected timing of completion of clinical trials 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 to be filed with the U.S. Securities and Exchange Commission (SEC) on March 6, 2018, 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.
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GlycoMimetics, Inc. |
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Condensed Statements of Operations |
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(In thousands, except share and per share data) |
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| Three months ended December 31, |
Year ended December 31, |
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| 2017 | 2016 | 2017 | 2016 | ||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||
| Revenue | $ | - | $ | - | $ | - | $ | 18 | |||||||||||||||||
| Costs and expenses: | |||||||||||||||||||||||||
| Research and development expense | 6,720 | 6,060 | 24,100 | 23,282 | |||||||||||||||||||||
| General and administrative expense | 2,816 | 2,298 | 9,832 | 8,650 | |||||||||||||||||||||
| Total costs and expenses | 9,536 | 8,358 | 33,932 | 31,932 | |||||||||||||||||||||
| Loss from operations | (9,536 | ) | (8,358 | ) | (33,932 | ) | (31,914 | ) | |||||||||||||||||
| Other income | 278 | 29 | 651 | 104 | |||||||||||||||||||||
| Net loss and net comprehensive loss | $ | (9,258 | ) | $ | (8,329 | ) | $ | (33,281 | ) | $ | (31,810 | ) | |||||||||||||
| Net loss per common share – basic and diluted | $ | (0.27 | ) | $ | (0.36 | ) | $ | (1.13 | ) | $ | (1.50 | ) | |||||||||||||
| Weighted average common shares – basic and diluted | 34,138,681 | 23,110,862 | 29,395,756 | 21,256,312 | |||||||||||||||||||||
| GlycoMimetics, Inc. | |||||||||||||||||||||||||
| Balance Sheet Data | |||||||||||||||||||||||||
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| December 31, | December 31, | ||||||||||||||||||||||||
| 2017 | 2016 | ||||||||||||||||||||||||
| Cash and cash equivalents | $ | 123,925 | $ | 40,042 | |||||||||||||||||||||
| Working capital | 119,045 | 34,187 | |||||||||||||||||||||||
| Total assets | 128,583 | 42,388 | |||||||||||||||||||||||
| Total liabilities | 8,882 | 7,087 | |||||||||||||||||||||||
| Total stockholders' equity | 119,701 | 35,301 | |||||||||||||||||||||||
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For GlycoMimetics:
Investors:
Shari Annes, 650-888-0902
sannes@annesassociates.com
or
Media:
Jamie
Lacey-Moreira, 410-299-3310
jamielacey@presscommpr.com
