GlycoMimetics Reports Fourth Quarter and Year-End 2017 Results
In an oral presentation of data from its Phase 1/2 AML trial of
GMI-1271 at the American Society of Hematology Annual Meeting (ASH),
- Improvements in median overall survival compared to historical matched controls for two AML patient populations
- Improvements in other clinical outcomes, including durability of remission in high-risk patients plus safety and tolerability data, including low mucositis rates
In a second oral presentation at the ASH meeting,
GlycoMimeticshighlighted the underlying, differentiated mechanism of action for GMI-1271, including its ability to enhance sensitivity to chemotherapy.
- The Phase 3 trial of rivipansel remains on track for completion during the second half of 2018.
GlycoMimeticswas included in the Nasdaq Biotechnology Index® (NBI), effective Monday, December 18, 2017.
Conference call scheduled for
8:30 a.m.this morning, dial-in and webcast details below.
“Highlighting the fourth quarter of 2017,
Recent Operational Highlights:
In the Phase 1/2 clinical trial, acute myeloid leukemia (AML) patients
treated with GMI-1271, a specific E-selectin inhibitor, together with
standard chemotherapy, consistently performed better than would be
expected based on historical controls, which have been derived from
results from third party clinical trials evaluating standard
chemotherapy, even with a population consisting of very high-risk
patients based on age, disease status, and cytogenetic risk
factors. The updated data announced at ASH in
December 2017reinforced earlier findings that disrupting the relationship between leukemic cells and the protective bone marrow microenvironment, when combined with chemotherapy, could improve outcomes for patients with AML.
Investigators continue to evaluate GMI-1271 as a therapy for multiple
myeloma in a European trial that has been expanded beyond its initial
Irelandto include other European Unionclinical centers. Preliminary results from this study are expected in the first quarter of 2019. GlycoMimeticscontinues to evaluate its product candidate, GMI-1359, which simultaneously targets both E-selectin and the chemokine CXCR4, in a Phase 1 dose-escalation study in healthy volunteers.
- Ongoing preclinical work is being focused on a new pipeline program targeted at the galectins, a biological target potentially important in treating certain cancers and fibrosis.
- In the Phase 3 trial of rivipansel, being conducted by our collaborator Pfizer, investigators are evaluating patients hospitalized for vaso-occlusive crisis of sickle cell disease. Pfizer reports that the study remains on track for completion in the second half of 2018.
Fourth Quarter 2017 Financial Results:
Cash position: As of
December 31, 2017, GlycoMimeticshad cash and cash equivalents of $123.9 millionas compared to $40.0 millionas of December 31, 2016.
R&D Expenses: The Company’s research and development expenses
$6.7 millionfor the quarter ended December 31, 2017as compared to $6.1 millionfor the fourth quarter of 2016. Research and development expenses increased by $0.8 million to $24.1 millionfor the year ended December 31, 2017, from $23.3 millionin the year ended December 31, 2016. During the year ended December 31, 2017, there was an increase in the manufacturing costs related to the clinical supplies for GMI-1271 as we advance towards a planned Phase 3 clinical trial, which increase was offset in part by a decrease in clinical expenses as the GMI-1271 Phase 2 clinical enrollment was completed in May 2017.
G&A Expenses: The Company’s general and administrative expenses
$2.8 millionfor the quarter ended December 31, 2017as compared to $2.3 millionfor the fourth quarter of 2016. General and administrative expenses for the year ended December 31, 2017increased to $9.8 millionas compared to $8.7 millionin the prior year. These increases were primarily due to increased labor-related costs and stock-based compensation expense.
Shares Outstanding: Shares outstanding as of
December 31, 2017were 34,359,799.
The company will host a conference call and webcast today at
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.
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.
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.
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
Condensed Statements of Operations
(In thousands, except share and per share data)
|Three months ended December 31,||
Year ended December 31,
|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||)|
|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||)||$||(1.50||)|
|Weighted average common shares – basic and diluted||34,138,681||23,110,862||29,395,756||21,256,312|
|Balance Sheet Data|
|December 31,||December 31,|
|Cash and cash equivalents||$||123,925||$||40,042|
|Total stockholders' equity||119,701||35,301|
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Shari Annes, 650-888-0902
Jamie Lacey-Moreira, 410-299-3310