GlycoMimetics Reports First Quarter 2018 Results
Based on guidance from the
US Food and Drug Administration( FDA), announced study design for GlycoMimetics-sponsored Phase 3 trial of candidate GMI-1271 in relapsed/refractory AML
- Signed study startup agreement with European consortium to prepare to conduct a trial in a second AML indication, i.e., both newly diagnosed patients who cannot tolerate intensive chemotherapy and myelodysplastic syndrome (MDS) patients with a high risk of leukemia
Raised net proceeds of approximately
$128.4 millionin a common stock offering, bringing quarter-end cash to $242.6 millionand extending expected cash runway through top-line data from GlycoMimetics-sponsored Phase 3 study in relapsed/refractory AML
“Our first-quarter 2018 accomplishments reflected both progress and
“Our overall plan also includes a trial in
The company will host a conference call and webcast today at
Key Operational Highlights for the First Quarter of 2018:
Based on guidance from the
US Food and Drug Administration( FDA), the company announced its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in individuals with relapsed/refractory AML. The single pivotal trial is planned to enroll approximately 380 adult patients at 30 to 40 centers in the United States, Canada, Europeand Australia, with enrollment expected to begin in the third quarter of 2018.
The company entered into an agreement with the
Haemato Oncology Foundation for Adultsin the Netherlands, or HOVON, to initiate clinical trial startup activities to evaluate GMI-1271 in adults with newly diagnosed AML but who cannot tolerate intensive chemotherapy, as well as in patients with myelodysplastic syndrome, or MDS, with a high risk of leukemia.
The company’s strategic partner Pfizer continues to enroll individuals
with sickle cell disease in its Phase 3 clinical study of rivipansel
for the treatment of vaso-occlusive crisis.
GlycoMimeticscontinues to expect rivipansel to advance to an anticipated topline Phase 3 readout in the fourth quarter of 2018.
First Quarter 2018 Financial Results:
Cash position: As of
March 31, 2018, GlycoMimeticshad cash and cash equivalents of $242.6 millionas compared to $123.9 millionas of December 31, 2017. GlycoMimeticssuccessfully completed a follow-on public offering of 8,050,000 shares netting proceeds of approximately $128.4 million.
R&D Expenses: The Company’s research and development expenses
$9.0 millionfor the quarter ended March 31, 2018as compared to $5.9 millionfor the first quarter of 2017. The increase was due to on-going costs related to manufacturing and process development for GMI-1271.
G&A Expenses: The Company’s general and administrative expenses
$2.9 millionfor the quarter ended March 31, 2018as compared to $2.1 millionfor the quarter ended March 31, 2017. The increase was due to higher patent, legal and non-cash stock-based compensation expenses.
Shares Outstanding: Shares outstanding as of
March 31, 2018were 42,490,110.
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. The
Rivipansel, the most advanced drug candidate in the
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, as well as the company’s belief that its cash resources
will be sufficient to meet its anticipated cash requirements through the
receipt of top-line data from the planned Phase 3 clinical trial of
GMI-1271 in individuals with relapsed/refractory AML. 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 March 31,|
|Cost and expenses:|
|Research and development expense||9,022||5,879|
|General and administrative expense||2,855||2,092|
|Total costs and expenses||11,877||7,971|
|Loss from operations||(11,877||)||(7,971||)|
|Net loss and comprehensive loss||$||(11,513||)||$||(7,932||)|
|Net loss per share - basic and diluted||$||(0.33||)||$||(0.34||)|
|Weighted average shares - basic and diluted||35,156,090||23,480,432|
|Balance Sheet Data|
|March 31,||December 31,|
|Cash and cash equivalents||$||242,632||$||123,925|