GlycoMimetics Reports Program Updates and First Quarter 2017 Results
- Completed enrollment in the first of two patient cohorts in the Phase 1/2 acute myeloid leukemia (AML) trial of GMI-1271
- Presented preclinical data for GMI-1271 and GMI-1359 in multiple myeloma at AACR Annual Meeting 2017
- Company management will host a conference call on Thursday, May 18, 2017 at 8:30 a.m. Eastern time to provide an update on development programs
"In the first quarter of 2017,
Company management will host a conference call on Thursday, May 18,
2017 at 8:30 a.m. Eastern time to provide a clinical data update from
the abstracts for the upcoming ASCO conference. A question and answer
session with the
Key Operational Highlights for the First Quarter of 2017:
- The first of two patient cohorts in the Phase 2 portion of the AML trial of GMI-1271 has completed enrollment. This cohort is comprised of 25 patients 60 years of age or older with newly diagnosed AML. The study is designed to evaluate the potential of GMI-1271, GlycoMimetics' E-selectin antagonist drug candidate, in combination with chemotherapy, as a treatment for patients with both newly diagnosed and relapsed/refractory AML. Enrollment in the study's second cohort is expected to complete in the middle of this year. The two arms combined will enroll a total of about 90 patients.
Pre-clinical research supporting the potential of two of its drug
candidates, GMI-1271 and GMI-1359, against multiple myeloma was shared
via an oral presentation at the
American Association for Cancer Research(AACR) Annual Meeting 2017. Combination therapy of carfilzomib with GMI-1271 or GMI-1359 prolonged survival of mice with multiple myeloma over treatment with carfilzomib alone.
The company announced that it will provide an update on clinical data
from its Phase 1/2 study of GMI-1271 in AML at the 2017
American Society for Clinical Oncologyin Chicago. GMI-1271 is an antagonist of E-selectin, for which prior clinical data has shown an emerging and differentiated potential efficacy and safety profile.
First Quarter 2017 Financial Results:
Cash position: As of
March 31, 2017, GlycoMimeticshad cash and cash equivalents of $34.6 millionas compared to $40.0 millionas of December 31, 2016. Subsequent to March 31, 2017, the Company has raised an additional $3.8 millionin net proceeds under the at-the-market facility.
R&D Expenses: The Company's research and development expenses
$5.9 millionfor the quarter ended March 31, 2017as compared to $5.5 millionfor the first quarter of 2016. The increase was due to on-going costs associated with the clinical trials for GMI-1271 in AML and MM, partially offset by a decrease in expenses related to manufacturing and process development for GMI-1271.
G&A Expenses: The company's general and administrative expenses
$2.1 millionfor both the quarters ended March 31, 2017and 2016.
Shares Outstanding: Shares outstanding as of
March 31, 2017were 23,855,934.
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.
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.
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 enrollment in and completion of clinical trials and
the presentation of clinical data at scientific conferences. 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
|Condensed Statements of Operations|
|(In thousands, except share and per share data)|
Three months ended
|Cost and expenses:|
|Research and development expense||5,879||5,519|
|General and administrative expense||2,092||2,056|
|Total costs and expenses||7,971||7,575|
|Loss from operations||(7,971||)||(7,575||)|
|Net loss and comprehensive loss||$||(7,932||)||$||(7,555||)|
|Net loss per share - basic and diluted||$||(0.34||)||$||(0.40||)|
|Weighted average shares - basic and diluted||23,480,432||19,071,838|
|Balance Sheet Data|
|Cash and cash equivalents||$||34,591||$||40,042|
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