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Share Name | Share Symbol | Market | Type |
---|---|---|---|
GlycoMimetics Inc | NASDAQ:GLYC | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.0021 | 0.69% | 0.3075 | 0.3075 | 0.3076 | 0.3246 | 0.2984 | 0.30 | 3,111,872 | 20:41:32 |
GlycoMimetics, Inc. (NASDAQ: GLYC) today reported progress on its clinical development programs and its financial results for the third quarter and nine months ended September 30, 2017.
The Company will host a conference call and webcast to provide a corporate update and report its third-quarter 2017 financial results 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 8794188. 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, participant code 8794188.
“In the third quarter of 2017, we initiated productive discussions with the FDA to review data emerging from the ongoing Phase 1/2 clinical trial of our specific E-selectin inhibitor product candidate, GMI-1271, for the treatment of acute myeloid leukemia (AML) and to plan a mid-2018 start of the Phase 3 trial. The discussions reflect the FDA’s granting of Breakthrough Therapy designation to GMI-1271 for the treatment of relapsed/refractory AML patients. Our focus is on finalizing the design of the registrational trial in relapsed/refractory disease. While in the near term we are preparing to provide an update on the GMI-1271 program via two oral presentations at the ASH meeting, we also continue to make progress across our clinical pipeline and in the preclinical arena,” stated Rachel King, Chief Executive Officer.
Key Operational Highlights for the Third Quarter of 2017:
Third Quarter 2017 Financial Results:
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 that has now completed enrollment, GMI-1271 is being evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations in this trial, patients treated with GMI-1271 together with standard chemotherapy have achieved higher than expected remission rates based on historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in these patient populations has been well tolerated with minimal adverse effects.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. Since E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow, the Company believes that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of both liquid and solid tumors that affect the bone marrow, as compared to targeting CXCR4 alone. GMI-1359 is currently being evaluated in a Phase 1 clinical trial.
About Rivipansel
Rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis (VOC) in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by GlycoMimetics’ strategic collaborator, Pfizer. Sickle cell disease is a genetic disease that, according to the U.S. Centers for Disease Control and Prevention, affects millions of people throughout the world, including an estimated 90,000 to 100,000 people in the United States. VOC is one of the most severe complications of sickle cell disease.
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, is being evaluated in an ongoing Phase 1/2 clinical trial as a potential treatment for AML and in a Phase 1 clinical trial for the treatment of multiple myeloma. The FDA has granted GMI-1271 Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory disease. GlycoMimetics has also 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 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.
GlycoMimetics, Inc. Condensed Statements of Operations (In thousands, except share and per share data)Three months ended September 30,
Nine months ended September 30, (Unaudited) (Unaudited) 2017 2016 2017 2016 Revenue $ - $ 18 $ - $ 18 Cost and expenses: Research and development expense 5,780 5,921 17,380 17,221 General and administrative expense 2,402 1,984 7,016 6,352 Total costs and expenses 8,182 7,905 24,396 23,573 Loss from operations (8,182 ) (7,887 ) (24,396 ) (23,555 ) Other income 232 32 373 74 Net loss and comprehensive loss $ (7,950 ) $ (7,855 ) $ (24,023 ) $ (23,481 ) Net loss per share - basic and diluted $ (0.24 ) $ (0.34 ) $ (0.86 ) $ (1.14 ) Weighted average shares - basic and diluted 32,724,010 23,049,347 27,814,781 20,638,129 GlycoMimetics, Inc. Balance Sheet Data (In thousands) September 30, December 31, 2017 2016 (unaudited) Cash and cash equivalents $ 112,873 $ 40,042 Working capital 107,357 34,187 Total assets 115,822 42,388 Total liabilities 7,258 7,087 Stockholders' equity 108,564 35,301
View source version on businesswire.com: http://www.businesswire.com/news/home/20171108005448/en/
GlycoMimetics, Inc.Investor Contact:Shari Annes, 650-888-0902sannes@annesassociates.comorMedia Contact:Jamie Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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