GlycoMimetics Reports Third Quarter 2018 Results and Highlights Recent Company Achievements
Continued to select new clinical sites and ready previously-selected
sites in the U.S.,
Europe, Canadaand Australiafor the company-sponsored Phase 3 pivotal trial in relapsed/refractory AML; study now open for enrollment
- Received notice of Japanese patent issuance in August for uproleselan (GMI-1271) composition of matter as well as pharmaceutical formulations, expiring in December 2032
November 1, announced that six abstracts have been accepted for oral and poster presentations at the Annual Meeting of the American Society of Hematology(ASH) in December
- An oral presentation at the Annual ASH meeting provides new and updated clinical outcomes data and subgroup analyses which continue to demonstrate potential benefit of treatment with uproleselan when added to chemotherapy
“During the third quarter, we focused our activity on planning and initiating GlycoMimetics’ comprehensive clinical program to evaluate uproleselan across the spectrum of AML. We expect to announce enrollment of the first patient in our own Phase 3 pivotal study of “upro” in relapsed/refractory patients within a very short period of time, as initiation activity is well underway at many sites, and enrollment is now open. Support among investigators for this trial as well as for our two consortia-led trials is strong. We believe that the data contained in the abstracts selected for oral and poster presentations at the ASH meeting reinforce the benefits already shared at prior medical meetings and bolster our confidence in upro’s potential to change the treatment paradigm in AML, whether patients have AML that is relapsed, refractory, or newly diagnosed,” said Rachel King, GlycoMimetics Chief Executive Officer.
Key Operational Highlights for the Third Quarter of 2018:
The company’s strategic partner Pfizer continued 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
GlycoMimeticsin August that enrollment was 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.
The GMI-sponsored pivotal Phase 3 trial of uproleselan in
relapsed/refractory AML is being initiated across multiple
investigative sites in the US, and work continues to expand to
clinical sites across
Europe, Canadaand Australia.
Planning advanced for the
National Cancer Institute(NCI) collaborative study of uproleselan in newly diagnosed patients fit for chemotherapy; a protocol including an interim analysis of event-free survival was finalized and posted on clinicaltrials.gov.
Planning continued for the collaborative
Haemato Oncology Foundation for Adultsin the Netherlands(HOVON) European study of uproleselan in newly diagnosed patients unfit for chemo with a goal of trial initiation in 2019.
Third Quarter 2018 Financial Results:
Cash position: As of
September 30, 2018, GlycoMimeticshad cash and cash equivalents of $219.8 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
$9.7 millionfor the quarter ended September 30, 2018as compared to $5.8 millionfor the prior year quarter. The increase was primarily due to an increase in clinical trial expenses related to the start-up of the Phase 3 clinical trial of uproleselan and higher manufacturing expenditures for uproleselan clinical supplies 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.
G&A Expenses: The Company’s general and administrative expenses
$2.8 millionfor the quarter ended September 30, 2018as compared to $2.4 millionfor the prior year quarter. The increase was primarily due to higher patent and other legal expenses.
Shares Outstanding: Shares outstanding as of
September 30, 2018were 43,137,227.
The company will host a conference call and webcast today at
About Uproleselan (GMI-1271)
Uproleselan (yoo’ pro le’sel an) 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
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. GlycoMimetics has completed a Phase 1 clinical trial of GMI-1359 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 enrollment in and conduct of clinical trials, the presentation
of clinical data, and expiration of issued patents. 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 September 30,||Nine months ended September 30,|
|Cost and expenses:|
|Research and development expense||9,729||5,780||28,053||17,380|
|General and administrative expense||2,790||2,402||8,492||7,016|
|Total costs and expenses||12,519||8,182||36,545||24,396|
|Loss from operations||(12,519||)||(8,182||)||(36,545||)||(24,396||)|
|Net loss and comprehensive loss||$||(11,575||)||$||(7,950||)||$||(34,367||)||$||(24,023||)|
|Net loss per share - basic and diluted||$||(0.27||)||$||(0.24||)||$||(0.85||)||$||(0.86||)|
|Weighted average shares - basic and diluted||43,069,282||32,724,010||40,345,071||27,814,781|
|Balance Sheet Data|
|September 30,||December 31,|
|Cash and cash equivalents||$||219,829||$||123,925|