GlycoMimetics Reports Second Quarter 2018 Results and Highlights Recent Company Achievements
Announced a Cooperative Research and Development Agreement (CRADA) to
collaborate with the
National Cancer Institute(NCI) and the Alliance for Clinical Trials in Oncology to fund a planned pivotal Phase 3 trial to evaluate uproleselan (GMI-1271) in older, newly diagnosed acute myeloid leukemia (AML) patients eligible for intensive chemotherapy
- Continued to select new clinical sites and ready previously-selected sites for the company’s sponsored Phase 3 pivotal trial
Presented preclinical research at the
American Association for CancerResearch (AACR) Annual Meeting 2018 in Chicago suggesting the potential anti-cancer activity of two of GlycoMimetics’ drug candidates, uproleselan and GMI-1359, as treatments for AML, metastasis in osteosarcoma and other cancers
“Our second-quarter 2018 accomplishments reflect significant progress as
we finalized our plans to conduct a comprehensive Phase 3 development
program for uproleselan across the spectrum of AML. With our
announcement in May of an NCI CRADA, in addition to the previously
announced trial in
Key Operational Highlights for the Second Quarter of 2018:
The company’s agreement with the NCI, part of the National Institutes
of Health (NIH), provides for
GlycoMimeticsto collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled clinical trial testing the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are eligible for intensive chemotherapy. The trial will be funded by the NCI. GlycoMimeticswill provide uproleselan as well as financial support to augment data analysis and monitoring. Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis, will lead this Phase 3 trial. The primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study.
At the AACR annual meeting, the company highlighted data from
preclinical models of selected cancers in which uproleselan and
GMI-1359, a dual antagonist of E-selectin and CXCR4, exhibited
anti-cancer activity. Key findings from the preclinical research
- Uproleselan could potentially be used with a hypomethylating agent, such as 5-azacitidine, to treat AML patients not healthy enough for intensive chemotherapy.
- GMI-1359 mobilized tumor-reactive T-cells from bone marrow, which could enhance effectiveness of treatments despite tumor resistance.
- Both tumor growth and metastasis of osteosarcoma to lung tissue were reduced with GMI-1359 treatment.
The company’s strategic partner Pfizer continues to enroll individuals
with sickle cell disease (SCD) in its Phase 3 clinical study of
rivipansel for the treatment of vaso-occlusive crisis (VOC). Pfizer
GlycoMimeticsthat enrollment is approximately 75% complete and is estimated to be completed in early 2019, with top-line data expected to be available in the second quarter of 2019.
Second Quarter 2018 Financial Results:
Cash position: As of
June 30, 2018, GlycoMimeticshad cash and cash equivalents of $229.4 millionas compared to $123.9 millionas of December 31, 2017. In March 2018, GlycoMimeticscompleted a public offering of 8,050,000 shares of common stock, yielding net proceeds of $128.4 million.
R&D Expenses: The Company’s research and development expenses
$9.3 millionfor the quarter ended June 30, 2018as compared to $5.7 millionfor the prior year quarter. The increase was primarily due to higher manufacturing costs for uproleselan clinical supplies as the Company prepares for our planned Phase 3 clinical trial and to meet our supply obligations for clinical trials of uproleselan conducted by or in collaboration with third parties. This increase was offset in part by a decrease in clinical trial expenses as patient enrollment for our Phase 1/2 clinical trial of uproleselan was completed in May 2017.
G&A Expenses: The Company’s general and administrative expenses
$2.8 millionfor the quarter ended June 30, 2018as compared to $2.5 millionfor the prior year quarter. The increase was primarily due to higher patent and other legal expenses.
Shares Outstanding: Shares outstanding as of
June 30, 2018were 43,055,424.
The company will host a conference call and webcast tomorrow,
About Uproleselan (GMI-1271)
Uproleselan 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, uproleselan was evaluated in both newly diagnosed
elderly and relapsed/refractory patients with AML. In both populations,
patients treated with uproleselan 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
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 multiple myeloma (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 June 30,||Six months ended June 30,|
|Cost and expenses:|
|Research and development expense||9,302||5,722||18,324||11,601|
|General and administrative expense||2,847||2,522||5,702||4,614|
|Total costs and expenses||12,149||8,244||24,026||16,215|
|Loss from operations||(12,149||)||(8,244||)||(24,026||)||(16,215||)|
|Net loss and comprehensive loss||$||(11,279||)||$||(8,142||)||$||(22,792||)||$||(16,073||)|
|Net loss per share - basic and diluted||$||(0.26||)||$||(0.30||)||$||(0.58||)||$||(0.63||)|
|Weighted average shares - basic and diluted||42,809,840||27,239,902||38,982,965||25,360,167|
|Balance Sheet Data|
|June 30,||December 31,|
|Cash and cash equivalents||$||229,435||$||123,925|