GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results for the quarter ended September 30, 2019 and highlighted recent business developments. Quarter-end cash and cash equivalents were $170.9 million.
“In the third quarter of 2019, we continued to progress the late-stage clinical development of our wholly-owned product candidate, uproleselan. Our Company-sponsored Phase 3 trial in relapsed or refractory AML patients and the NCI-sponsored Phase 3 trial for newly diagnosed patients with AML both advanced during the quarter. We are also working with the Duke Cancer Institute towards initiating a single center, proof-of-mechanism Phase 1b trial for GMI-1359, our dual antagonist of E-selectin and CXCR-4, in breast cancer patients with bone metastases,” said Rachel King, GlycoMimetics’ Chief Executive Officer.
Ms. King continued, “We are also very much looking forward to the ASH meeting in December, which has always been an important conference for us, and this year is no different. The key takeaway for us at this year’s ASH meeting is that data from multiple preclinical and clinical settings show that E-selectin ligand expression on leukemic cells is correlated with poor survival in AML. The data indicate that E-selectin ligand expression is a key driver of environmental-mediated chemoresistance in AML and suggest that uproleselan has the potential to break this chemoresistance, and thereby improve clinical outcomes. Based on this expanding dataset, we are exploring how use of biomarkers may help us in advancing our clinical program.
“Finally, as previously announced, Pfizer reported that its Phase 3 clinical trial evaluating rivipansel in SCD failed to meet its primary endpoint and key secondary endpoints. Of course, this is disappointing, but for some time our operational focus has been on our uproleselan program in AML, and we continue to focus our efforts on diligently and efficiently progressing that exciting clinical program,” Ms. King added.
Key Third-Quarter 2019 and Recent Operational Developments:
- GlycoMimetics’ pivotal Phase 3 trial of uproleselan in relapsed/refractory AML continued to initiate and activate clinical sites and to enroll patients in the U.S., Australia and now in Europe.
- Investigators continued to enroll patients in the NCI-sponsored Phase 3 clinical trial designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy.
- Pfizer announced that the Phase 3 clinical trial evaluating rivipansel in SCD failed to meet the primary endpoint and key secondary endpoints.
- As part of a commitment to eliminate certain non-core research and development spending, GlycoMimetics discontinued plans to collaborate with the Haemato Oncology Foundation for Adults in the Netherlands on a Phase 2 trial of uproleselan in newly-diagnosed patients unfit for chemotherapy.
- The Company continued to work closely with the Duke Cancer Institute to initiate a Phase 1b proof-of-mechanism clinical trial of GMI-1359 in individuals with breast cancer whose tumors have spread to bone. The trial will evaluate safety and biomarkers of cancer cell mobilization in individuals with hormone receptor positive metastatic breast cancer. The trial will be conducted at Duke University and is expected to initiate during the fourth quarter.
Third Quarter 2019 Financial Results:
- Cash position: As of September 30, 2019, GlycoMimetics had cash and cash equivalents of $170.9 million as compared to $209.9 million as of December 31, 2018.
- R&D Expenses: The Company’s research and development expenses increased to $10.7 million for the quarter ended September 30, 2019 as compared to $9.7 million for the third quarter of 2018. This increase was primarily the result of expenses relating to the Company’s Phase 3 clinical trial of uproleselan in relapsed or refractory AML patients and supporting the clinical trials of uproleselan conducted by or in collaboration with third parties.
- G&A Expenses: The Company’s general and administrative expenses increased to $3.4 million for the quarter ended September 30, 2019 as compared to $2.8 million for the third quarter of 2018. The increase was due to higher patent, legal and non-cash stock-based compensation expenses.
- Shares Outstanding: Shares outstanding as of September 30, 2019 were 43,359,949.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 9845948. To access the live audio webcast, or the subsequent archived recording, visit the “Investors – Events & Presentations” section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.-Business Wire